Some light reading about the test kit instructions
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Posted On: 01/24/2021 12:38:27 PM
Some light reading about the test kit instructions to help pass the time over the weekend.
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Other coronaviruses are capable of causing illnesses ranging from the common cold to more severe diseases such as Middle East respiratory syndrome( MERS). It ...
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ARS-CoV-2 Antigen Rapid Qualitative Test
Instructions for Use
For prescription only
For in vitro diagnostic use only
Please read these instructions completely before beginning testing of
specimens.
INTENDED USE
The SARS-CoV-2 Antigen Rapid Qualitative Test is a colloidal gold
immunochromatography intended for the qualitative detection of nucleocapsid antigens
from SARS-CoV-2 in human nasal swabs or throat swabs from individuals who are
suspected of COVID-19 by their healthcare provider. within the first five days of the onset
of symptoms.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is
generally detectable in upper respiratory samples or lower respiratory samples during the
acute phase of infection. Positive results indicate the presence of viral antigens, but clinical
correlation with patient history and other diagnostic information is necessary to determine
infection status. Positive results do not rule out bacterial infection or co-infection with
other viruses. The agent detected may not be the definite cause of disease.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole
basis for treatment or patient management decisions, including infection control decisions.
Negative results should be considered in the context of a patient’s recent exposures, history
and the presence of clinical signs and symptoms consistent with COVID-19, and
confirmed with a molecular assay, if necessary for patient management.
The SARS-CoV-2 Antigen Rapid Qualitative Test is intended for use by trained clinical
laboratory personnel specifically instructed and trained in the techniques of in vitro
diagnostic procedures, and proper infection control procedures and individuals similarly
trained in point of care settings.
SUMMARY
SARS-CoV-2 belongs to the broad family of viruses known as coronaviruses. It is a
positive-sense single-stranded RNA (+ssRNA) virus. Other coronaviruses are capable of
causing illnesses ranging from the common cold to more severe diseases such as Middle
East respiratory syndrome(MERS). It is the seventh known coronavirus to infect people,
after 229E, NL63, OC43, HKU1, MERS-CoV, and the original SARS-CoV. Protein
modeling experiments on the spike (S) protein of the virus suggest that it has sufficient
affinity to the angiotensin converting enzyme 2 (ACE2) receptors of human cells to use
them as a mechanism of cell entry. Studies have shown that SARS-CoV-2 has a higher
affinity to human ACE2 than the original SARS virus strain.
SARS-CoV-2 infections cause COVID-19 disease. People who have confirmed COVID-
19 have a range of symptoms, from people with little to no symptoms to people being
severely sick and dying. Symptoms can include: fever, tiredness, and dry cough.. Some
patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea.
These symptoms are usually mild and begin gradually. Some people become infected but
don’t develop any symptoms and don't feel unwell. Most people (about 80%) recover from
the disease without needing special treatment. Around 1 out of every 6 people who gets
COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and
those with underlying medical problems like high blood pressure, heart problems or
diabetes, are more likely to develop serious illness. About 2% of people with the disease
have died. People with fever, cough and difficulty breathing should seek medical attention.
Human-to-human transmission of the virus has been confirmed and occurs primarily via
respiratory droplets from coughs and sneezes within a range of about 6 feet (1.8m). Viral
RNA has also been found in stool specimens from infected patients. It is possible that the
virus can be infectious even during the incubation period, but this has not been proven,
and the WHO stated on 1 February 2020 that "transmission from asymptomatic cases is
likely not a major driver of transmission" at this time.
The median incubation time is estimated to be approximately 5 days with symptoms
estimated to be present within 12 days of infection.3 The symptoms of COVID-19 are
similar to other viral respiratory diseases and include fever, cough, shortness of breath.
PRINCIPLES OF THE PROCEDURE
This reagent is based on colloidal gold immunochromatography assay.
During the test, specimen extracts are applied to the test cartridges. If there were SARS-
CoV-2 antigen in the extract, the antigen will bind to the SARS-CoV-2 monoclonal
antibody. During lateral flow, the complex will move along the nitrocellulose membrane
toward the end of the absorbent paper. When passing the test line (line T, coated with
another SARS-CoV-2 monoclonal antibody) the complex is captured by SARS-CoV-2
antibody on test line resulting in coloring on line T; when passing the line C, colloidal
gold-labeled goat anti-rabbit IgG is captured by control line (line C, coated with rabbit IgG)
resulting in coloring on line C.
REAGENTS
The following components are included in the SARS-CoV-2 Antigen Rapid Qualitative
Test for rapid detection of SARS-CoV-2 kit
Materials Provided:
25-Test Kit:
1. SARS-CoV-2 Antigen Test Cartridge (25): Monoclonal anti-SARS antibodies
2.Extraction Tubes (25)
3.Extraction solution: 2 bottles/kit (enough for 25 test)
4.Instructions for use 1 copy/kit
5.QC Card (located on kit box)
Optional Materials:
1.Throat Swabs (25)
2.Nasal Swabs (25)
Materials Required but not provided:
1. Timer
2 Tube rack for specimens
3.Any necessary personal protective equipment
4.External control set (including 1negative controls and 1 positive controls).
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use.
2. This test has been authorized only for the detection of proteins from SARS-CoV-2, not
for any other viruses or pathogens.
3. Do not use this kit beyond the expiration date printed on the outside carton.
4. Do not use the kit to evaluate patient specimens if either the positive control swab or
negative control swab fail to give expected results.
5. Test results are meant to be visually determined.
6. To avoid erroneous results, specimens must be processed as indicated in the assay
procedure section.
7. Do not reuse any kit components.
8. When collecting a nasal swab sample, use the nasal swab supplied in the kit. Use of
alternative swabs may result in false negative results.
9. Proper specimen collection, storage and transport are critical to the performance of this
test.
10. Specific training or guidance is recommended if operators are not experienced with
specimen collection and handling procedures. Wear protective clothing such as laboratory
coats, disposable gloves, and eye protection when specimens are collected and evaluated.
Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency
Virus, may be present in clinical specimens. Standard precautions and institutional
guidelines should always be followed in handling, storing, and disposing of all specimens
and all items contaminated with blood or other body fluids.
11. The SARS-CoV-2 external positive control have been prepared from recombinant viral
proteins and do not contain infectious material.
12. Dispose of used test kits as biohazardous waste in accordance with federal, state and
local requirements.
13. For additional information on hazard symbols, safety, handling and disposal of the
components within this kit, please refer to the Safety Data Sheet (SDS) located at bd.com.
14. Wear suitable protective clothing, gloves, and eye/face protection when handling the
contents of this kit.
STORAGE CONDITIONS & PERIOD OF VALIDITY
1. Store extraction solution at 2-30℃, the shelf life is 24 months tentatively.
2. Store the test cartridge at 2-30℃, the shelf life is 24months tentatively.
3.Test Cartridge should be used right after opening the pouch.
Reagents and devices must be at room temperature (15–30 °C) when used for testing.
SPECIMEN COLLECTION AND HANDING
Specimen Collection and Preparation
Throat Swab Specimen Collection:
Let the patient's head tilt slightly, mouth open, and make "ah" sounds, exposing the
pharyngeal tonsils on both sides. Hold the swab and wipe the pharyngeal tonsils on both
sides of the patient with moderate force back and forth for at least 3 times.
Nasal Swab Specimen Collection:
1.Insert the swab into one nostril of the patient. The swab tip should be inserted up to 2.5
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cm (1 inch) from the edge of the nostril.
2.Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and
cells are collected
3. Using the same swab, repeat this process for the other nostril to ensure that an adequate
sample is collected from both nasal cavities. Withdraw the swab from the nasal cavity.
① ② ③
Specimen Transport and Storage:
Samples should be tested as soon as possible after collection. Based on data generated with
influenza virus, throat swabs are stable for up to 24-hours at room temperature or 2° to
8°C.
TEST METHODS
The test should be operated at room temperature（15-30℃）.
1. Place the extraction tube with opening facing up. Press the extraction solution bottle to
drip 6 drops of extract solution into the extractor tube without touching the edge of the
tube.
2. The extraction of specimen: Put the swab had collected specimen into the extraction
tube, hold and press the swab head against the wall of tube with force while rotating the
swab for about 10 seconds to release the antigen into the extraction solution from the swab
head.
3. Removing swab: Squeeze the swab head while removing the swab in order to remove
as much liquid as possible from the swab. Dispose of swabs according to biohazard waste
disposal regulations.
4. Install the nozzle cap onto the extraction tube.
5. Loading: drip 2 drops of extraction solution into the sample well of the test cartridge,
and start the timer.
6. Read the results at 20~30 minutes. Strong positive results can be reported at 20 minutes,
however, negative results must be reported after 30 minutes. If positive signal appears after
30 minutes, it should not be reported as positive.
Drip extract solution Extraction Removing swab
Install the nozzle Loading Reading
INTERPRETATION OF TEST RESULTS
Line C must be colored to have a valid test result.
Valid results:
Negative result: There is coloration on line C only showing as following picture,
suggesting that there is no SARS-CoV-2 antigen in the specimen.
Positive result: There are coloration on both line C and line T showing as follow pictures,
suggesting that there is SARS-CoV-2 antigen in the specimen.
Invalid result: There is no coloration on line C, as shown in the following pictures. The
test is invalid or an error in operation occurred. Repeat the assay with a new cartridge.
REPORTING OF RESULTS
Positive Test:
Positive for the presence of SARS-CoV-2 antigen. Positive results indicate the presence of
viral antigens, but clinical correlation with patient history and other diagnostic information
is necessary to determine infection status. Positive results do not rule out bacterial infection
or co-infection with other viruses. The agent detected may not be the definite cause of
disease. Laboratories within the United States and its territories are required to report all
positive results to the appropriate public health authorities.
Negative Test :
Negative results are presumptive. Negative test results do not preclude infection and
should not be used as the sole basis for treatment or other patient management decisions,
including infection control decisions, particularly in the presence of clinical signs and
symptoms consistent with COVID-19, or in those who have been in contact with the virus.
It is recommended that these results be confirmed by a molecular testing method, if
necessary, for patient management Control.
Invalid:
Do not report results. Repeat the test.
QUALITY CONTROL
The SARS CoV-2 Antigen Control Set (catalog number: 1339) is available to purchase
separately from Xiamen Biotime Biotechnology Co., Ltd as external controls. The control
set can be ordered through website (www.biotime.cn), telephone (+86-592-6883156) and
email (baotai@biotime.cn). One negative and one positive control are included in the
control set. Returning expected test results for each control in the control set indicates
appropriate performance of SARS-CoV-2 Antigen Rapid Qualitative Test. If any control
of the control set fail to provide the expected result, reasons that have led to failure
including the test kit, the operator, the environment, the test procedure and any other causes
which may affect the test result should be analyzed and corrective action taken. Clinical
specimens can be run in the Biotime SARS-CoV-2 Antigen Rapid Qualitative Test. If all
the control set results observed are the expected results. Please refer to the Instructions For
Use of Biotime SARS-CoV-2 Antigen Control Set for expected test results as well as other
information. It is recommended that the controls are tested when:
A. A new operator uses the kit;
B. A new lot of test kits is used;
C. A new shipment of kits is used;
D. The temperature used during storage of the kit falls outside of the recommended
conditions;
E. The temperature of the test area falls outside of 15-30°C;
F. To verify a higher than expected frequency of positive or negative results;
G. To investigate the cause of repeated invalid results; or
H. A new test environment is used (e.g., natural light vs. artificial light).
I. As required by external quality control procedures and in accordance with local, state
and federal regulations or accreditation requirements.
NOTE: Prepare kit control swabs and test using the same procedure as used for patient
specimens. Failure of the external/procedural controls will generate an invalid test result.
If the kit controls do not perform as expected, do not report patient results. Contact Xiamen
Biotime Biotechnology Co., Ltd Technical Services at (+86-592-6883577) and email
(baotai@biotime.cn).
LIMITATIONS OF THE PROCEDURE
1.Clinical performance was evaluated with frozen samples, and test performance may be
different with fresh samples.
2.Users should test specimens as quickly as possible after specimen collection.
3.Positive test results do not rule out co-infections with other pathogens.
4.Results from SARS-CoV-2 Antigen Rapid Qualitative Test should be correlated with the
clinical history, epidemiological data, and other data available to the clinician evaluating
the patient.
5.A false-negative test result may occur if the level of viral antigen in a sample is below
the detection limit of the test or if the sample was collected or transported improperly;
therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
6.The amount of antigen in a sample may decrease as the duration of illness increases.
Specimens collected after day 5 of illness are more likely to be negative compared to a RT-
PCR assay.
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7.Failure to follow the test procedure may adversely affect test performance and/or
invalidate the test result.
8.The contents of this kit are to be used for the qualitative detection of SARS-CoV-2
antigens from throat or nasal swab specimens only.
9.The kits for rapid detection of SARS-Cov-2 can detect both viable and non-viable SARS-
CoV-2 material. The SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of
SARS-CoV-2 performance depends on antigen load and may not correlate with other
diagnostic methods performed on the same specimen.
10.Negative test results are not intended to rule in other non-SARS-CoV-2 viral or bacterial
infections.
11.Positive and negative predictive values are highly dependent on prevalence rates.
Positive test results are more likely to represent false positive results during periods of
little/no SARS-CoV-2 activity when disease prevalence is low. False negative test results
are more likely when prevalence of disease caused by SARS-CoV-2 is high.
12.This device has been evaluated for use with human specimen material only.
13.Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2
viruses that have undergone minor amino acid changes in the target epitope region.
14.The performance of this test has not been evaluated for use in patients without signs
and symptoms of respiratory infection and performance may differ in asymptomatic
individuals.
15.Sensitivity of the test after the first five days of the onset of symptoms has been
demonstrated to decrease as compared to a RT-PCR SARS-CoV-2 assay.
16.The kit was validated with the assorted swabs. Use of alternative swabs may result in
false negative results.
17.Specimen stability recommendations are based upon stability data from influenza
testing and performance may be different with SARS-CoV-2. Users should test specimens
as quickly as possible after specimen collection, and within one hour after specimen
collection.
18.The validity of SARS-CoV-2 Antigen Rapid Qualitative Test has not been proven for
dentification/confirmation of tissue culture isolates and should not be used in this capacity.
CLINICAL PERFORMANCE
The performance of the Biotime SARS-CoV-2 Antigen Rapid Qualitative Test for rapid
detection of SARS-CoV-2 was established with 295 direct nasal swab or throat swab
prospectively collected and enrolled from individual symptomatic patients (within 5 days
of onset) who were spected of COVID-19. As with all antigen tests, performance may
decrease as days since symptom onset increases. For each type, four kinds of samples from
the same person were tested by Company’s Kit. We selected 25 positive and 25 negative
sample. P1-P25 of samples are from infected people, and NI-N25 are from uninfected
people. P21-P25 are weekly positive.
Method PCR Test
Total
Results
Biotime Results
Results positive Negative
positive 72 0 72
Negative 3 220 223
Total Results 75 220 295
* 95% Confidence Interval
ANALYTICAL PERFORMANCE
LIMIT OF DETECTION (ANALYTICAL SENSITIVITY)
LOD of human sputum matrix
The LOD for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-
CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 antigen (bei
Resources NR-52286). The material was supplied frozen at a concentration of TCID50 of
3.40 x105 per mL.
In this study, designed to estimate the LOD of the assay when using a direct throat swab, the
starting material was spiked into a volume of pooled human sputum obtained from healthy
donors and confirmed negative for SARS-CoV-2. An initial range finding study was
performed testing devices in triplicate using a 10-fold dilution series of 3 replicates per
concentration. At each dilution, 50 µL samples were added to swabs and then tested in the
assay using the procedure appropriate for patient throat swab specimens. A concentration
was chosen between the last dilution to give 3 positive results and the first to give 3 negative
results. Using this concentration, the LOD was further refined with a 2-fold dilution series
of 3 replicates per concentration. The last dilution demonstrating 100% positivity was then
tested in an additional 20 replicates tested in the same way.
Starting Material
Concentration
Estimated
LOD No. Positive/Total % Positive
3.40 x 105 TCID50/mL 4.25 x 10²
TCID50/mL 19/20 95%
LOD of human nasal swab specimen matrix
The LOD for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-
CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 (bei
Resources NR-52286). The material was supplied frozen at a concentration of TCID50 of
3.40 x105
per mL.
In this study, designed to estimate the LOD of the assay when using a direct throat swab, the
starting material was spiked into a volume of pooled human nasal swab specimen obtained
from healthy donors and confirmed negative for SARS-CoV-2. An initial range finding study
was performed testing devices in triplicate using a 10-fold dilution series of 3 replicates per
concentration. At each dilution, 50 µL samples were added to swabs and then tested in the
assay using the procedure appropriate for patient nasal swab specimens. A concentration was
chosen between the last dilution to give 3 positive results and the first to give 3 negative
results. Using this concentration, the LOD was further refined with a 2-fold dilution series
of 3 replicates per concentration. The last dilution demonstrating 100% positivity was then
tested in an additional 20 replicates tested in the same way.
Starting Material
Concentration Estimated LOD No. Positive/Total % Positive
3.40 x 105
TCID50/mL
3.40 x 102
TCID50/mL 19/20 95%
CROSS REACTIVITY (ANALYTICAL SPECIFICITY)
Human sputum matrix
Cross-reactivity of the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of
SARS-CoV-2 was evaluated by testing a panel of high prevalence respiratory pathogens
that could potentially cross-react with the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2. Each organism and virus spiked into negative throat
specimen was wet-tested in triplicate. The final concentration of each organism is
documented in the following table
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
Relative Sensitivity: 72/75 96.00% (88.75%～99.17%)
Relative Specificity: 220/220 100.00% (98.34%～100.00%)
Accuracy: 292/295 98.98% (97.06%～99.79%)
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18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii
(PJP) 2.0 x 106 TCID50/mL NO
Note :1 TCID50/mL≈0.7CFU/ml
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react.
Human nasal swab specimen matrix
Cross-reactivity of the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of
SARS-CoV-2 was evaluated by testing a panel of high prevalence respiratory pathogens
that could potentially cross-react with the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2. Each organism and virus spiked into negative nasal
specimen was wet-tested in triplicate. The final concentration of each organism is
documented in the following table.
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii (PJP) 2.0 x 106 TCID50/mL NO
Note :1 TCID50/mL≈0.7CFU/ml
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react.
MICROBIAL INTERFERENCE STUDIES
Human sputum matrix
The microbial interference studies for the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-
inactivated SARS-CoV-2 (bei Resources NR-52286).
The material was supplied frozen at a concentration of TCID50 of 3.40 x105
per mL. the
starting material was spiked into a volume of pooled human sputum (the most challenging
respiratory matrix) obtained from healthy donors and confirmed negative for SARS-CoV-
2. Based on the LOD studies, a low (3x LoD) SARS-CoV-2 concentration of 1.275x 103
TCID50/mL was chosen. The specimen was confirmed positive for SARS-CoV-2 with
faintly line on Line T. Furthermore, the above-mentioned specimen was divided into
30.Finally, the microorganism indicated below was respectively spiked into the divided
specimen to obtain microbial interference specimens that SARS-CoV-2 is present in a
specimen with one microorganism.
Each microbial interference specimen was tested individually. At each test, 50 µL samples
were added to swab. The results shows that the specimen was confirmed positive for
SARS-CoV-2 with faintly line on Line T. Based on the study, no appreciable interference
was observed for the following substances at the spiked levels indicated below in sputum
matrix.
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
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16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii (PJP) 2.0 x 106 TCID50/mL NO
Human nasal swab specimen matrix
The microbial interference studies for the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-
inactivated SARS-CoV-2 (bei Resources NR-52286).
The material was supplied frozen at a concentration of TCID50 of 3.40 x105
per mL. the
starting material was spiked into a volume of pooled nasal swab specimen (the most
challenging respiratory matrix) obtained from healthy donors and confirmed negative for
SARS-CoV-2. Based on the LOD studies, a low (3x LoD) SARS-CoV-2 concentration of
1.02x 103 TCID50/mL was chosen. The specimen was confirmed positive for SARS-CoV-
2 with faintly line on Line T. Furthermore, the above-mentioned specimen was divided
into 30.Finally, the microorganism indicated below was respectively spiked into the
divided specimen to obtain microbial interference specimens that SARS-CoV-2 is present
in a specimen with one microorganism.
Each microbial interference specimen was tested individually. At each test, 50 µL samples
were added to swab. The results shows that the specimen was confirmed positive for
SARS-CoV-2 with faintly line on Line T. Based on the study, no appreciable interference
was observed for the following substances at the spiked levels indicated below in nasal
swab specimen matrix.
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii (PJP) 2.0 x 106 TCID50/mL NO
Endogenous Interference Substances Studies:
Human sputum matrix
A study was performed demonstrate that eighteen (18) potentially interfering substances
that may be found in the lower respiratory tract do not cross-react or interfere with the
detection of SARS-CoV-2 in the SARS-CoV-2 Antigen Rapid Qualitative Test.
S.N Interfering Substance Concentration
Cross-
Reactive
Results
Interference
Results**
1 Whole Blood 4% Negative Positive
2 Mucin 0.50% Negative Positive
3 Ricola (Menthol) 1.5 mg/mL Negative Positive
4
Sucrets
(Dyclonin/Menthol) 1.5 mg/mL Negative Positive
5
Chloraseptic
(Menthol/Benzocaine 1.5 mg/mL Negative Positive
6 Naso GEL (NeilMed) 5% v/v Negative Positive
7
CVS Nasal Drops
(Phenylephrine) 15% v/v Negative Positive
8 Afrin (Oxymetazoline) 15% v/v Negative Positive
9
CVS Nasal Spray
(Cromolyn) 15% v/v Negative Positive
10 Nasal Gel
(Oxymetazoline) 10% v/v Negative Positive
11 Zicam 5% v/v Negative Positive
12 Homeopathic (Alkalol) 1:10 dilution Negative Positive
13 Fisherman’s Friend 1.5 mg/mL Negative Positive
14 ore Throat Phenol Spray 15% v/v Negative Positive
15 Tobramycin 4μg/mL Negative Positive
Innova Medical Group Inc.
16 Mupirocin 10 mg/mL Negative Positive
17 Fluticasone Propionate 5% v/v Negative Positive
18 Tamiflu (Oseltamivir
Phosphate) 5mg/mL Negative Positive
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react or interfere.
Human nasal swab specimen matrix
A study was performed demonstrate that eighteen (18) potentially interfering substances
that may be found in the upper respiratory tract do not cross-react or interfere with the
detection of SARS-CoV-2 in the SARS-CoV-2 Antigen Rapid Qualitative Test.
S.N Interfering Substance Concentration
Cross-
Reactive
Results
Interference
Results**
1 Whole Blood 4% Negative Positive
2 Mucin 0.50% Negative Positive
3 Ricola (Menthol) 1.5 mg/mL Negative Positive
4
Sucrets
(Dyclonin/Menthol) 1.5 mg/mL Negative Positive
5
Chloraseptic
(Menthol/Benzocaine 1.5 mg/mL Negative Positive
6 Naso GEL (NeilMed) 5% v/v Negative Positive
7
CVS Nasal Drops
(Phenylephrine) 15% v/v Negative Positive
8 Afrin (Oxymetazoline) 15% v/v Negative Positive
9
CVS Nasal Spray
(Cromolyn) 15% v/v Negative Positive
10 Nasal Gel
(Oxymetazoline) 10% v/v Negative Positive
11 Zicam 5% v/v Negative Positive
12 Homeopathic (Alkalol) 1:10 dilution Negative Positive
13 Fisherman’s Friend 1.5 mg/mL Negative Positive
14 ore Throat Phenol Spray 15% v/v Negative Positive
15 Tobramycin 4μg/mL Negative Positive
16 Mupirocin 10 mg/mL Negative Positive
17 Fluticasone Propionate 5% v/v Negative Positive
18 Tamiflu (Oseltamivir
Phosphate) 5mg/mL Negative Positive
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react or interfere.
HIGH DOSE HOOK EFFECT
As part of the LoD study the highest concentration of heat-inactivated SARS-CoV-2 stock
available (TCID50 of 3.40 x105
per mL) was tested. There was no Hook effect detected.
INDEX OF SYMBOLS
Symbol Description Symbol Description
In vitro diagnostic
medical device
Do not re-use
Expiry date
Consult instructions for
use
Warning, please refer
to the instruction
Manufacturer
Store at 2-30℃ Lot number
Keep away from
sunlight
Keep dry
European authorized
representative
Don’t use the product
when the package is
damaged
Date of manufacture Biological risks
For Prescription Only CE mark
Sterilized using
ethylene oxide
IN VITRO DIAGNOSTIC MEDICAL DEVICE TECHNICAL
ASSISTANCE
For technical assistance, call Biotime Technical Services at +86-592-688-3577, email
baotai@biotime.cn, or visit Biotime website at http:// www.biotime.cn.
GENERAL INFORMATION
Manufactured by:
Xiamen Biotime Biotechnology Co., Ltd
Address: 3F/4F, No. 188, Pingcheng South Road, Haicang District, Xiamen, Fujian,
361026, P.R.China
Tel: +86-592-6883577
Fax: +86-592-6882362
www.biotime.cn
Manufactured for: Innova Medical Group Inc.
Innova Medical Group Inc.
Address: 718 S. Primrose Ave, Monrovia, CA 91016, USA
Tel: 626-239 0025
Fax: 626-239 0038
www.innovamedgroup.com
Version: A/02
Issuing date: 2020-07-01
Search: cdn.website-editor.net › filesPDF Innova SARS-Cov-2 Antigen Test IFU
Other coronaviruses are capable of causing illnesses ranging from the common cold to more severe diseases such as Middle East respiratory syndrome( MERS). It ...
6 pages·1 MB
ARS-CoV-2 Antigen Rapid Qualitative Test
Instructions for Use
For prescription only
For in vitro diagnostic use only
Please read these instructions completely before beginning testing of
specimens.
INTENDED USE
The SARS-CoV-2 Antigen Rapid Qualitative Test is a colloidal gold
immunochromatography intended for the qualitative detection of nucleocapsid antigens
from SARS-CoV-2 in human nasal swabs or throat swabs from individuals who are
suspected of COVID-19 by their healthcare provider. within the first five days of the onset
of symptoms.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is
generally detectable in upper respiratory samples or lower respiratory samples during the
acute phase of infection. Positive results indicate the presence of viral antigens, but clinical
correlation with patient history and other diagnostic information is necessary to determine
infection status. Positive results do not rule out bacterial infection or co-infection with
other viruses. The agent detected may not be the definite cause of disease.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole
basis for treatment or patient management decisions, including infection control decisions.
Negative results should be considered in the context of a patient’s recent exposures, history
and the presence of clinical signs and symptoms consistent with COVID-19, and
confirmed with a molecular assay, if necessary for patient management.
The SARS-CoV-2 Antigen Rapid Qualitative Test is intended for use by trained clinical
laboratory personnel specifically instructed and trained in the techniques of in vitro
diagnostic procedures, and proper infection control procedures and individuals similarly
trained in point of care settings.
SUMMARY
SARS-CoV-2 belongs to the broad family of viruses known as coronaviruses. It is a
positive-sense single-stranded RNA (+ssRNA) virus. Other coronaviruses are capable of
causing illnesses ranging from the common cold to more severe diseases such as Middle
East respiratory syndrome(MERS). It is the seventh known coronavirus to infect people,
after 229E, NL63, OC43, HKU1, MERS-CoV, and the original SARS-CoV. Protein
modeling experiments on the spike (S) protein of the virus suggest that it has sufficient
affinity to the angiotensin converting enzyme 2 (ACE2) receptors of human cells to use
them as a mechanism of cell entry. Studies have shown that SARS-CoV-2 has a higher
affinity to human ACE2 than the original SARS virus strain.
SARS-CoV-2 infections cause COVID-19 disease. People who have confirmed COVID-
19 have a range of symptoms, from people with little to no symptoms to people being
severely sick and dying. Symptoms can include: fever, tiredness, and dry cough.. Some
patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea.
These symptoms are usually mild and begin gradually. Some people become infected but
don’t develop any symptoms and don't feel unwell. Most people (about 80%) recover from
the disease without needing special treatment. Around 1 out of every 6 people who gets
COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and
those with underlying medical problems like high blood pressure, heart problems or
diabetes, are more likely to develop serious illness. About 2% of people with the disease
have died. People with fever, cough and difficulty breathing should seek medical attention.
Human-to-human transmission of the virus has been confirmed and occurs primarily via
respiratory droplets from coughs and sneezes within a range of about 6 feet (1.8m). Viral
RNA has also been found in stool specimens from infected patients. It is possible that the
virus can be infectious even during the incubation period, but this has not been proven,
and the WHO stated on 1 February 2020 that "transmission from asymptomatic cases is
likely not a major driver of transmission" at this time.
The median incubation time is estimated to be approximately 5 days with symptoms
estimated to be present within 12 days of infection.3 The symptoms of COVID-19 are
similar to other viral respiratory diseases and include fever, cough, shortness of breath.
PRINCIPLES OF THE PROCEDURE
This reagent is based on colloidal gold immunochromatography assay.
During the test, specimen extracts are applied to the test cartridges. If there were SARS-
CoV-2 antigen in the extract, the antigen will bind to the SARS-CoV-2 monoclonal
antibody. During lateral flow, the complex will move along the nitrocellulose membrane
toward the end of the absorbent paper. When passing the test line (line T, coated with
another SARS-CoV-2 monoclonal antibody) the complex is captured by SARS-CoV-2
antibody on test line resulting in coloring on line T; when passing the line C, colloidal
gold-labeled goat anti-rabbit IgG is captured by control line (line C, coated with rabbit IgG)
resulting in coloring on line C.
REAGENTS
The following components are included in the SARS-CoV-2 Antigen Rapid Qualitative
Test for rapid detection of SARS-CoV-2 kit
Materials Provided:
25-Test Kit:
1. SARS-CoV-2 Antigen Test Cartridge (25): Monoclonal anti-SARS antibodies
2.Extraction Tubes (25)
3.Extraction solution: 2 bottles/kit (enough for 25 test)
4.Instructions for use 1 copy/kit
5.QC Card (located on kit box)
Optional Materials:
1.Throat Swabs (25)
2.Nasal Swabs (25)
Materials Required but not provided:
1. Timer
2 Tube rack for specimens
3.Any necessary personal protective equipment
4.External control set (including 1negative controls and 1 positive controls).
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use.
2. This test has been authorized only for the detection of proteins from SARS-CoV-2, not
for any other viruses or pathogens.
3. Do not use this kit beyond the expiration date printed on the outside carton.
4. Do not use the kit to evaluate patient specimens if either the positive control swab or
negative control swab fail to give expected results.
5. Test results are meant to be visually determined.
6. To avoid erroneous results, specimens must be processed as indicated in the assay
procedure section.
7. Do not reuse any kit components.
8. When collecting a nasal swab sample, use the nasal swab supplied in the kit. Use of
alternative swabs may result in false negative results.
9. Proper specimen collection, storage and transport are critical to the performance of this
test.
10. Specific training or guidance is recommended if operators are not experienced with
specimen collection and handling procedures. Wear protective clothing such as laboratory
coats, disposable gloves, and eye protection when specimens are collected and evaluated.
Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency
Virus, may be present in clinical specimens. Standard precautions and institutional
guidelines should always be followed in handling, storing, and disposing of all specimens
and all items contaminated with blood or other body fluids.
11. The SARS-CoV-2 external positive control have been prepared from recombinant viral
proteins and do not contain infectious material.
12. Dispose of used test kits as biohazardous waste in accordance with federal, state and
local requirements.
13. For additional information on hazard symbols, safety, handling and disposal of the
components within this kit, please refer to the Safety Data Sheet (SDS) located at bd.com.
14. Wear suitable protective clothing, gloves, and eye/face protection when handling the
contents of this kit.
STORAGE CONDITIONS & PERIOD OF VALIDITY
1. Store extraction solution at 2-30℃, the shelf life is 24 months tentatively.
2. Store the test cartridge at 2-30℃, the shelf life is 24months tentatively.
3.Test Cartridge should be used right after opening the pouch.
Reagents and devices must be at room temperature (15–30 °C) when used for testing.
SPECIMEN COLLECTION AND HANDING
Specimen Collection and Preparation
Throat Swab Specimen Collection:
Let the patient's head tilt slightly, mouth open, and make "ah" sounds, exposing the
pharyngeal tonsils on both sides. Hold the swab and wipe the pharyngeal tonsils on both
sides of the patient with moderate force back and forth for at least 3 times.
Nasal Swab Specimen Collection:
1.Insert the swab into one nostril of the patient. The swab tip should be inserted up to 2.5
Innova Medical Group Inc.
cm (1 inch) from the edge of the nostril.
2.Roll the swab 5 times along the mucosa inside the nostril to ensure that both mucus and
cells are collected
3. Using the same swab, repeat this process for the other nostril to ensure that an adequate
sample is collected from both nasal cavities. Withdraw the swab from the nasal cavity.
① ② ③
Specimen Transport and Storage:
Samples should be tested as soon as possible after collection. Based on data generated with
influenza virus, throat swabs are stable for up to 24-hours at room temperature or 2° to
8°C.
TEST METHODS
The test should be operated at room temperature（15-30℃）.
1. Place the extraction tube with opening facing up. Press the extraction solution bottle to
drip 6 drops of extract solution into the extractor tube without touching the edge of the
tube.
2. The extraction of specimen: Put the swab had collected specimen into the extraction
tube, hold and press the swab head against the wall of tube with force while rotating the
swab for about 10 seconds to release the antigen into the extraction solution from the swab
head.
3. Removing swab: Squeeze the swab head while removing the swab in order to remove
as much liquid as possible from the swab. Dispose of swabs according to biohazard waste
disposal regulations.
4. Install the nozzle cap onto the extraction tube.
5. Loading: drip 2 drops of extraction solution into the sample well of the test cartridge,
and start the timer.
6. Read the results at 20~30 minutes. Strong positive results can be reported at 20 minutes,
however, negative results must be reported after 30 minutes. If positive signal appears after
30 minutes, it should not be reported as positive.
Drip extract solution Extraction Removing swab
Install the nozzle Loading Reading
INTERPRETATION OF TEST RESULTS
Line C must be colored to have a valid test result.
Valid results:
Negative result: There is coloration on line C only showing as following picture,
suggesting that there is no SARS-CoV-2 antigen in the specimen.
Positive result: There are coloration on both line C and line T showing as follow pictures,
suggesting that there is SARS-CoV-2 antigen in the specimen.
Invalid result: There is no coloration on line C, as shown in the following pictures. The
test is invalid or an error in operation occurred. Repeat the assay with a new cartridge.
REPORTING OF RESULTS
Positive Test:
Positive for the presence of SARS-CoV-2 antigen. Positive results indicate the presence of
viral antigens, but clinical correlation with patient history and other diagnostic information
is necessary to determine infection status. Positive results do not rule out bacterial infection
or co-infection with other viruses. The agent detected may not be the definite cause of
disease. Laboratories within the United States and its territories are required to report all
positive results to the appropriate public health authorities.
Negative Test :
Negative results are presumptive. Negative test results do not preclude infection and
should not be used as the sole basis for treatment or other patient management decisions,
including infection control decisions, particularly in the presence of clinical signs and
symptoms consistent with COVID-19, or in those who have been in contact with the virus.
It is recommended that these results be confirmed by a molecular testing method, if
necessary, for patient management Control.
Invalid:
Do not report results. Repeat the test.
QUALITY CONTROL
The SARS CoV-2 Antigen Control Set (catalog number: 1339) is available to purchase
separately from Xiamen Biotime Biotechnology Co., Ltd as external controls. The control
set can be ordered through website (www.biotime.cn), telephone (+86-592-6883156) and
email (baotai@biotime.cn). One negative and one positive control are included in the
control set. Returning expected test results for each control in the control set indicates
appropriate performance of SARS-CoV-2 Antigen Rapid Qualitative Test. If any control
of the control set fail to provide the expected result, reasons that have led to failure
including the test kit, the operator, the environment, the test procedure and any other causes
which may affect the test result should be analyzed and corrective action taken. Clinical
specimens can be run in the Biotime SARS-CoV-2 Antigen Rapid Qualitative Test. If all
the control set results observed are the expected results. Please refer to the Instructions For
Use of Biotime SARS-CoV-2 Antigen Control Set for expected test results as well as other
information. It is recommended that the controls are tested when:
A. A new operator uses the kit;
B. A new lot of test kits is used;
C. A new shipment of kits is used;
D. The temperature used during storage of the kit falls outside of the recommended
conditions;
E. The temperature of the test area falls outside of 15-30°C;
F. To verify a higher than expected frequency of positive or negative results;
G. To investigate the cause of repeated invalid results; or
H. A new test environment is used (e.g., natural light vs. artificial light).
I. As required by external quality control procedures and in accordance with local, state
and federal regulations or accreditation requirements.
NOTE: Prepare kit control swabs and test using the same procedure as used for patient
specimens. Failure of the external/procedural controls will generate an invalid test result.
If the kit controls do not perform as expected, do not report patient results. Contact Xiamen
Biotime Biotechnology Co., Ltd Technical Services at (+86-592-6883577) and email
(baotai@biotime.cn).
LIMITATIONS OF THE PROCEDURE
1.Clinical performance was evaluated with frozen samples, and test performance may be
different with fresh samples.
2.Users should test specimens as quickly as possible after specimen collection.
3.Positive test results do not rule out co-infections with other pathogens.
4.Results from SARS-CoV-2 Antigen Rapid Qualitative Test should be correlated with the
clinical history, epidemiological data, and other data available to the clinician evaluating
the patient.
5.A false-negative test result may occur if the level of viral antigen in a sample is below
the detection limit of the test or if the sample was collected or transported improperly;
therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
6.The amount of antigen in a sample may decrease as the duration of illness increases.
Specimens collected after day 5 of illness are more likely to be negative compared to a RT-
PCR assay.
Innova Medical Group Inc.
7.Failure to follow the test procedure may adversely affect test performance and/or
invalidate the test result.
8.The contents of this kit are to be used for the qualitative detection of SARS-CoV-2
antigens from throat or nasal swab specimens only.
9.The kits for rapid detection of SARS-Cov-2 can detect both viable and non-viable SARS-
CoV-2 material. The SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of
SARS-CoV-2 performance depends on antigen load and may not correlate with other
diagnostic methods performed on the same specimen.
10.Negative test results are not intended to rule in other non-SARS-CoV-2 viral or bacterial
infections.
11.Positive and negative predictive values are highly dependent on prevalence rates.
Positive test results are more likely to represent false positive results during periods of
little/no SARS-CoV-2 activity when disease prevalence is low. False negative test results
are more likely when prevalence of disease caused by SARS-CoV-2 is high.
12.This device has been evaluated for use with human specimen material only.
13.Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2
viruses that have undergone minor amino acid changes in the target epitope region.
14.The performance of this test has not been evaluated for use in patients without signs
and symptoms of respiratory infection and performance may differ in asymptomatic
individuals.
15.Sensitivity of the test after the first five days of the onset of symptoms has been
demonstrated to decrease as compared to a RT-PCR SARS-CoV-2 assay.
16.The kit was validated with the assorted swabs. Use of alternative swabs may result in
false negative results.
17.Specimen stability recommendations are based upon stability data from influenza
testing and performance may be different with SARS-CoV-2. Users should test specimens
as quickly as possible after specimen collection, and within one hour after specimen
collection.
18.The validity of SARS-CoV-2 Antigen Rapid Qualitative Test has not been proven for
dentification/confirmation of tissue culture isolates and should not be used in this capacity.
CLINICAL PERFORMANCE
The performance of the Biotime SARS-CoV-2 Antigen Rapid Qualitative Test for rapid
detection of SARS-CoV-2 was established with 295 direct nasal swab or throat swab
prospectively collected and enrolled from individual symptomatic patients (within 5 days
of onset) who were spected of COVID-19. As with all antigen tests, performance may
decrease as days since symptom onset increases. For each type, four kinds of samples from
the same person were tested by Company’s Kit. We selected 25 positive and 25 negative
sample. P1-P25 of samples are from infected people, and NI-N25 are from uninfected
people. P21-P25 are weekly positive.
Method PCR Test
Total
Results
Biotime Results
Results positive Negative
positive 72 0 72
Negative 3 220 223
Total Results 75 220 295
* 95% Confidence Interval
ANALYTICAL PERFORMANCE
LIMIT OF DETECTION (ANALYTICAL SENSITIVITY)
LOD of human sputum matrix
The LOD for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-
CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 antigen (bei
Resources NR-52286). The material was supplied frozen at a concentration of TCID50 of
3.40 x105 per mL.
In this study, designed to estimate the LOD of the assay when using a direct throat swab, the
starting material was spiked into a volume of pooled human sputum obtained from healthy
donors and confirmed negative for SARS-CoV-2. An initial range finding study was
performed testing devices in triplicate using a 10-fold dilution series of 3 replicates per
concentration. At each dilution, 50 µL samples were added to swabs and then tested in the
assay using the procedure appropriate for patient throat swab specimens. A concentration
was chosen between the last dilution to give 3 positive results and the first to give 3 negative
results. Using this concentration, the LOD was further refined with a 2-fold dilution series
of 3 replicates per concentration. The last dilution demonstrating 100% positivity was then
tested in an additional 20 replicates tested in the same way.
Starting Material
Concentration
Estimated
LOD No. Positive/Total % Positive
3.40 x 105 TCID50/mL 4.25 x 10²
TCID50/mL 19/20 95%
LOD of human nasal swab specimen matrix
The LOD for the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of SARS-
CoV-2 was established using limiting dilutions of heat-inactivated SARS-CoV-2 (bei
Resources NR-52286). The material was supplied frozen at a concentration of TCID50 of
3.40 x105
per mL.
In this study, designed to estimate the LOD of the assay when using a direct throat swab, the
starting material was spiked into a volume of pooled human nasal swab specimen obtained
from healthy donors and confirmed negative for SARS-CoV-2. An initial range finding study
was performed testing devices in triplicate using a 10-fold dilution series of 3 replicates per
concentration. At each dilution, 50 µL samples were added to swabs and then tested in the
assay using the procedure appropriate for patient nasal swab specimens. A concentration was
chosen between the last dilution to give 3 positive results and the first to give 3 negative
results. Using this concentration, the LOD was further refined with a 2-fold dilution series
of 3 replicates per concentration. The last dilution demonstrating 100% positivity was then
tested in an additional 20 replicates tested in the same way.
Starting Material
Concentration Estimated LOD No. Positive/Total % Positive
3.40 x 105
TCID50/mL
3.40 x 102
TCID50/mL 19/20 95%
CROSS REACTIVITY (ANALYTICAL SPECIFICITY)
Human sputum matrix
Cross-reactivity of the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of
SARS-CoV-2 was evaluated by testing a panel of high prevalence respiratory pathogens
that could potentially cross-react with the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2. Each organism and virus spiked into negative throat
specimen was wet-tested in triplicate. The final concentration of each organism is
documented in the following table
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
Relative Sensitivity: 72/75 96.00% (88.75%～99.17%)
Relative Specificity: 220/220 100.00% (98.34%～100.00%)
Accuracy: 292/295 98.98% (97.06%～99.79%)
Innova Medical Group Inc.
18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii
(PJP) 2.0 x 106 TCID50/mL NO
Note :1 TCID50/mL≈0.7CFU/ml
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react.
Human nasal swab specimen matrix
Cross-reactivity of the SARS-CoV-2 Antigen Rapid Qualitative Test for rapid detection of
SARS-CoV-2 was evaluated by testing a panel of high prevalence respiratory pathogens
that could potentially cross-react with the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2. Each organism and virus spiked into negative nasal
specimen was wet-tested in triplicate. The final concentration of each organism is
documented in the following table.
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii (PJP) 2.0 x 106 TCID50/mL NO
Note :1 TCID50/mL≈0.7CFU/ml
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react.
MICROBIAL INTERFERENCE STUDIES
Human sputum matrix
The microbial interference studies for the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-
inactivated SARS-CoV-2 (bei Resources NR-52286).
The material was supplied frozen at a concentration of TCID50 of 3.40 x105
per mL. the
starting material was spiked into a volume of pooled human sputum (the most challenging
respiratory matrix) obtained from healthy donors and confirmed negative for SARS-CoV-
2. Based on the LOD studies, a low (3x LoD) SARS-CoV-2 concentration of 1.275x 103
TCID50/mL was chosen. The specimen was confirmed positive for SARS-CoV-2 with
faintly line on Line T. Furthermore, the above-mentioned specimen was divided into
30.Finally, the microorganism indicated below was respectively spiked into the divided
specimen to obtain microbial interference specimens that SARS-CoV-2 is present in a
specimen with one microorganism.
Each microbial interference specimen was tested individually. At each test, 50 µL samples
were added to swab. The results shows that the specimen was confirmed positive for
SARS-CoV-2 with faintly line on Line T. Based on the study, no appreciable interference
was observed for the following substances at the spiked levels indicated below in sputum
matrix.
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
Innova Medical Group Inc.
16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii (PJP) 2.0 x 106 TCID50/mL NO
Human nasal swab specimen matrix
The microbial interference studies for the SARS-CoV-2 Antigen Rapid Qualitative Test
for rapid detection of SARS-CoV-2 was established using limiting dilutions of heat-
inactivated SARS-CoV-2 (bei Resources NR-52286).
The material was supplied frozen at a concentration of TCID50 of 3.40 x105
per mL. the
starting material was spiked into a volume of pooled nasal swab specimen (the most
challenging respiratory matrix) obtained from healthy donors and confirmed negative for
SARS-CoV-2. Based on the LOD studies, a low (3x LoD) SARS-CoV-2 concentration of
1.02x 103 TCID50/mL was chosen. The specimen was confirmed positive for SARS-CoV-
2 with faintly line on Line T. Furthermore, the above-mentioned specimen was divided
into 30.Finally, the microorganism indicated below was respectively spiked into the
divided specimen to obtain microbial interference specimens that SARS-CoV-2 is present
in a specimen with one microorganism.
Each microbial interference specimen was tested individually. At each test, 50 µL samples
were added to swab. The results shows that the specimen was confirmed positive for
SARS-CoV-2 with faintly line on Line T. Based on the study, no appreciable interference
was observed for the following substances at the spiked levels indicated below in nasal
swab specimen matrix.
S.N. Potential Cross-Reactant Concentration Tested
Cross-
Reactivity
(Yes/No)
1 Human coronavirus 229E 2.0 x 105 TCID50/mL NO
2 Human coronavirus OC43 2.0 x 105 TCID50/mL NO
3 Human coronavirus NL63 2.0 x 105 TCID50/mL NO
4 SARS-coronavirus 2.0 x 105 TCID50/mL NO
5 MERS-coronavirus 2.0 x 105 TCID50/mL NO
6 Human coronavirus HKU1 2.0 x 105 TCID50/mL NO
7 Adenovirus C1 2.0 x 105 TCID50/mL NO
8 Adenovirus 71 2.0 x 105 TCID50/mL NO
9
Human Metapneumovirus
(hMPV) 2.0 x 105 TCID50/mL NO
10 Parainfluenza virus 1-4 2.0 x 105 TCID50/mL NO
11 Influenza A 2.0 x 105 TCID50/mL NO
12 Influenza B 2.0 x 105 TCID50/mL NO
13 Enterovirus 2.0 x 105 TCID50/mL NO
14 Respiratory syncytial virus 2.0 x 105 TCID50/mL NO
15 Rhinovirus 2.0 x 105 TCID50/mL NO
16 Haemophilus influenzae 2.0 x 106 TCID50/mL NO
17 Streptococcus pneumoniae 2.0 x 106 TCID50/mL NO
18 Streptococcus pyogenes 2.0 x 106 TCID50/mL NO
19 Candida albicans 2.0 x 106 TCID50/mL NO
20
Pooled human nasal wash –
representative of normal
respiratory microbial flora
2.0 x 106 TCID50/mL NO
21 Bordetella pertussis 2.0 x 106 TCID50/mL NO
22 Mycoplasma pneumoniae 2.0 x 106 TCID50/mL NO
23 Chlamydia pneumoniae 2.0 x 106 TCID50/mL NO
24 Legionella pneumophila 2.0 x 106 TCID50/mL NO
25 Mycobacterium tuberculosis 2.0 x 106 TCID50/mL NO
26 Pneumocystis jirovecii (PJP) 2.0 x 106 TCID50/mL NO
Endogenous Interference Substances Studies:
Human sputum matrix
A study was performed demonstrate that eighteen (18) potentially interfering substances
that may be found in the lower respiratory tract do not cross-react or interfere with the
detection of SARS-CoV-2 in the SARS-CoV-2 Antigen Rapid Qualitative Test.
S.N Interfering Substance Concentration
Cross-
Reactive
Results
Interference
Results**
1 Whole Blood 4% Negative Positive
2 Mucin 0.50% Negative Positive
3 Ricola (Menthol) 1.5 mg/mL Negative Positive
4
Sucrets
(Dyclonin/Menthol) 1.5 mg/mL Negative Positive
5
Chloraseptic
(Menthol/Benzocaine 1.5 mg/mL Negative Positive
6 Naso GEL (NeilMed) 5% v/v Negative Positive
7
CVS Nasal Drops
(Phenylephrine) 15% v/v Negative Positive
8 Afrin (Oxymetazoline) 15% v/v Negative Positive
9
CVS Nasal Spray
(Cromolyn) 15% v/v Negative Positive
10 Nasal Gel
(Oxymetazoline) 10% v/v Negative Positive
11 Zicam 5% v/v Negative Positive
12 Homeopathic (Alkalol) 1:10 dilution Negative Positive
13 Fisherman’s Friend 1.5 mg/mL Negative Positive
14 ore Throat Phenol Spray 15% v/v Negative Positive
15 Tobramycin 4μg/mL Negative Positive
Innova Medical Group Inc.
16 Mupirocin 10 mg/mL Negative Positive
17 Fluticasone Propionate 5% v/v Negative Positive
18 Tamiflu (Oseltamivir
Phosphate) 5mg/mL Negative Positive
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react or interfere.
Human nasal swab specimen matrix
A study was performed demonstrate that eighteen (18) potentially interfering substances
that may be found in the upper respiratory tract do not cross-react or interfere with the
detection of SARS-CoV-2 in the SARS-CoV-2 Antigen Rapid Qualitative Test.
S.N Interfering Substance Concentration
Cross-
Reactive
Results
Interference
Results**
1 Whole Blood 4% Negative Positive
2 Mucin 0.50% Negative Positive
3 Ricola (Menthol) 1.5 mg/mL Negative Positive
4
Sucrets
(Dyclonin/Menthol) 1.5 mg/mL Negative Positive
5
Chloraseptic
(Menthol/Benzocaine 1.5 mg/mL Negative Positive
6 Naso GEL (NeilMed) 5% v/v Negative Positive
7
CVS Nasal Drops
(Phenylephrine) 15% v/v Negative Positive
8 Afrin (Oxymetazoline) 15% v/v Negative Positive
9
CVS Nasal Spray
(Cromolyn) 15% v/v Negative Positive
10 Nasal Gel
(Oxymetazoline) 10% v/v Negative Positive
11 Zicam 5% v/v Negative Positive
12 Homeopathic (Alkalol) 1:10 dilution Negative Positive
13 Fisherman’s Friend 1.5 mg/mL Negative Positive
14 ore Throat Phenol Spray 15% v/v Negative Positive
15 Tobramycin 4μg/mL Negative Positive
16 Mupirocin 10 mg/mL Negative Positive
17 Fluticasone Propionate 5% v/v Negative Positive
18 Tamiflu (Oseltamivir
Phosphate) 5mg/mL Negative Positive
Based on the data generated by this study, the substances tested SARS-CoV-2 Antigen
Rapid Qualitative Test do not cross-react or interfere.
HIGH DOSE HOOK EFFECT
As part of the LoD study the highest concentration of heat-inactivated SARS-CoV-2 stock
available (TCID50 of 3.40 x105
per mL) was tested. There was no Hook effect detected.
INDEX OF SYMBOLS
Symbol Description Symbol Description
In vitro diagnostic
medical device
Do not re-use
Expiry date
Consult instructions for
use
Warning, please refer
to the instruction
Manufacturer
Store at 2-30℃ Lot number
Keep away from
sunlight
Keep dry
European authorized
representative
Don’t use the product
when the package is
damaged
Date of manufacture Biological risks
For Prescription Only CE mark
Sterilized using
ethylene oxide
IN VITRO DIAGNOSTIC MEDICAL DEVICE TECHNICAL
ASSISTANCE
For technical assistance, call Biotime Technical Services at +86-592-688-3577, email
baotai@biotime.cn, or visit Biotime website at http:// www.biotime.cn.
GENERAL INFORMATION
Manufactured by:
Xiamen Biotime Biotechnology Co., Ltd
Address: 3F/4F, No. 188, Pingcheng South Road, Haicang District, Xiamen, Fujian,
361026, P.R.China
Tel: +86-592-6883577
Fax: +86-592-6882362
www.biotime.cn
Manufactured for: Innova Medical Group Inc.
Innova Medical Group Inc.
Address: 718 S. Primrose Ave, Monrovia, CA 91016, USA
Tel: 626-239 0025
Fax: 626-239 0038
www.innovamedgroup.com
Version: A/02
Issuing date: 2020-07-01
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