More details on the approved rapid antigen home te
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Posted On: 03/06/2021 11:45:35 AM
More details on the approved rapid antigen home tests in Germany.
German Stores to Begin Selling COVID-19 Rapid Antigen Tests for Home Use
Mar 05, 2021 | staff reporter
This article has been updated with additional information from the German Federal Ministry of Health.
NEW YORK – Stores in Germany will start selling COVID-19 rapid antigen tests to consumers on Saturday following approval by German regulators last month.
Germany's Federal Institute for Drugs and Medical Devices (BfArM) recently granted special approval to seven COVID-19 rapid antigen tests for home use.
The tests are expected to become widely available in supermarket chains, drug stores, pharmacies, and online over the next few weeks, starting this weekend.
The first seven tests, approved under the German Medical Devices Act, are
Healgen Scientific's Clinitest Rapid COVID-19 Self-Test (distributed by Siemens Healtcare Diagnostics),
Xiamen Boson Biotech's Rapid SARS-CoV-2 Antigen Test Card (distributed by Technomed Service),
Hangzhou Laihe Biotech's Lyer Covid-19 Antigen Schnelltest (distributed by Lissner Qi),
SD Biosensor's SARS-CoV-2 Rapid Antigen Test (distributed by MT Promedt Consulting),
Ameda Labordiagnostik's AMP Rapid Test SARS-CoV-2 Ag,
Beijing Hotgen Biotech's Coronavirus (2019-nCoV)-Antigentest, and
Aesku.Diagnostics' Aesku.Rapid SARS-CoV-2 test.
BfArM said this initial list of tests will continuously be updated and expand over time.
The institute can authorize medical devices in Germany that have not undergone the standard conformity assessment procedure for CE marking for a limited period of time and under exceptional circumstances if such authorization is in the interest of public health.
German grocery discounter Aldi said on Friday that SARS-CoV-2 rapid antigen tests manufactured in Germany will be sold in its stores starting March 6 at a price of €24.99 ($29.80) for a pack of five tests .
COVID-19 rapid antigen home tests, known in Germany as "self-tests," are expected to play an important role in the country's strategy for reopening its economy. While Germany is slowly making progress with vaccinations after a slow start, infections have remained at levels deemed too high for a full reopening. Frequent testing is supposed to speed up the process, allowing some areas of the economy to ramp up even before infections decline significantly.
Besides authorizing sales of coronavirus tests in stores, the government is also expanding the use of rapid antigen tests at existing testing sites. According to Germany's Federal Ministry of Health, starting March 8, all residents are eligible to receive at least one free rapid antigen test per week at a local test center.
In a press conference on Friday, German Health Minister Jens Spahn said that "more than enough" rapid tests are available and can be easily ordered by test centers. "Manufacturers are telling us their warehouses are full," he said.
According to Spahn, manufacturers are able to deliver 20 million self-tests per week, sufficient to allow each student to be tested twice a week, for example.
However, Spahn cautioned that expanding rapid tests and home tests doesn't provide absolute security. "Those who test positive should have their result validated immediately by a PCR test," he said. "Those who test negative should not get a false sense of security. It remains important to maintain distance, hygiene, and to wear medical facial masks."
https://www.360dx.com/point-care-testing/germ...EOhDWhKiUk
https://www.bfarm.de/DE/Medizinprodukte/Antig..._node.html
German Stores to Begin Selling COVID-19 Rapid Antigen Tests for Home Use
Mar 05, 2021 | staff reporter
This article has been updated with additional information from the German Federal Ministry of Health.
NEW YORK – Stores in Germany will start selling COVID-19 rapid antigen tests to consumers on Saturday following approval by German regulators last month.
Germany's Federal Institute for Drugs and Medical Devices (BfArM) recently granted special approval to seven COVID-19 rapid antigen tests for home use.
The tests are expected to become widely available in supermarket chains, drug stores, pharmacies, and online over the next few weeks, starting this weekend.
The first seven tests, approved under the German Medical Devices Act, are
Healgen Scientific's Clinitest Rapid COVID-19 Self-Test (distributed by Siemens Healtcare Diagnostics),
Xiamen Boson Biotech's Rapid SARS-CoV-2 Antigen Test Card (distributed by Technomed Service),
Hangzhou Laihe Biotech's Lyer Covid-19 Antigen Schnelltest (distributed by Lissner Qi),
SD Biosensor's SARS-CoV-2 Rapid Antigen Test (distributed by MT Promedt Consulting),
Ameda Labordiagnostik's AMP Rapid Test SARS-CoV-2 Ag,
Beijing Hotgen Biotech's Coronavirus (2019-nCoV)-Antigentest, and
Aesku.Diagnostics' Aesku.Rapid SARS-CoV-2 test.
BfArM said this initial list of tests will continuously be updated and expand over time.
The institute can authorize medical devices in Germany that have not undergone the standard conformity assessment procedure for CE marking for a limited period of time and under exceptional circumstances if such authorization is in the interest of public health.
German grocery discounter Aldi said on Friday that SARS-CoV-2 rapid antigen tests manufactured in Germany will be sold in its stores starting March 6 at a price of €24.99 ($29.80) for a pack of five tests .
COVID-19 rapid antigen home tests, known in Germany as "self-tests," are expected to play an important role in the country's strategy for reopening its economy. While Germany is slowly making progress with vaccinations after a slow start, infections have remained at levels deemed too high for a full reopening. Frequent testing is supposed to speed up the process, allowing some areas of the economy to ramp up even before infections decline significantly.
Besides authorizing sales of coronavirus tests in stores, the government is also expanding the use of rapid antigen tests at existing testing sites. According to Germany's Federal Ministry of Health, starting March 8, all residents are eligible to receive at least one free rapid antigen test per week at a local test center.
In a press conference on Friday, German Health Minister Jens Spahn said that "more than enough" rapid tests are available and can be easily ordered by test centers. "Manufacturers are telling us their warehouses are full," he said.
According to Spahn, manufacturers are able to deliver 20 million self-tests per week, sufficient to allow each student to be tested twice a week, for example.
However, Spahn cautioned that expanding rapid tests and home tests doesn't provide absolute security. "Those who test positive should have their result validated immediately by a PCR test," he said. "Those who test negative should not get a false sense of security. It remains important to maintain distance, hygiene, and to wear medical facial masks."
https://www.360dx.com/point-care-testing/germ...EOhDWhKiUk
https://www.bfarm.de/DE/Medizinprodukte/Antig..._node.html
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