Reliable rapid tests identify with certainty
Created: 2/8/2022Updated: 2/8/2022 1:03 PM
Rapid antigen tests: high sensitivity is crucial.
© Hangzhou Alltest Biotech Co.Ltd
Corona test centers are reaching their capacity, making rapid antigen tests all the more important.
The selection is large, as are the differences in quality.
How to find the right test.
In addition to vaccines, rapid antigen tests are an elementary part of fighting the pandemic.
Especially since infections with Covid-19 are increasing and test centers are reaching their capacity limits.
Given the large number of tests available, it is not easy for the layperson to identify reliable products.
Not all tests sold by manufacturers/distributors in pharmacies, drugstores, supermarkets, and online are safe
.
Rosa Wu, Vice-President R&D of Hangzhou AllTest Biotech Co., Ltd, shows what to look out for when selecting the test and refers to the websites of the Paul Ehrlich Institute (PEI) and the Federal Institute for Drugs and Medical Devices ( BfArM).
These maintain regularly updated lists of approved tests and thus offer consumers, companies and the public sector important orientation.
Rapid antigen tests for personal use have been approved since the beginning of 2021
.
It is easy to use, as is the case with the PEI-approved AllTest antigen rapid test, which delivers a result after about 15 minutes: Depending on the product variant, a swab is taken from the nose or spit into a container, and the sample is then treated according to the instructions and has a result after a short time: SARS-CoV-2 positive or negative.
Corona tests: High sensitivity required
The tests that are available are constantly changing, as manufacturers keep improving their products.
In order to obtain approval, providers submit all the necessary documentation on the product to the Federal Institute for Drugs and Medical Devices and the tests themselves to the Paul-Ehrlich-Institut for evaluation.
Only those antigen rapid tests are approved that meet the strict requirements of the test centers.
The decisive factor is the amount of virus that is necessary for the test to deliver a positive result.
The sooner the test works - that is, the more sensitive it is to small amounts of virus in a sample - the more informative it is.
A value of 75 percent to a Ct value of less than or equal to 25 is considered the minimum accepted sensitivity. The Ct value (cycle threshold value) is a measure of the amount of virus in the sample.
The lower this value, the fewer multiplication cycles were necessary before the increase in the viral genome becomes exponential, and the higher the virus concentration in the sample - and the higher the risk of infection in the person tested.
Alltest Rapid Antigen Test © Hangzhou Alltest Biotech Co.Ltd
AllTest rapid antigen tests achieve the required sensitivity
Not all products achieve this value right away.
Critical products for failed products can therefore be found on the internet again and again.
For example, scientists from the Paul-Ehrlich-Institut tested around 122 SARS-CoV-2 rapid antigen tests or rapid antigen tests with CE marking offered in Germany in 2021.
About a fifth of these did not achieve the required sensitivity, including a rapid test from Hangzhou AllTest Biotech, which is no longer in circulation.
In the meantime, AllTest has made significant improvements.
The new products meet the minimum requirements of the PEI with very good results
: The Hangzhou AllTest saliva test scores 100 percent, while the manufacturer's nasal swab test scores 90 percent.
The high level of reliability has recently been confirmed by other institutions – including the Therapeutic Goods Administration (TGA) – and studies.
The website of the Paul-Ehrlich-Institut or the Federal Institute for Drugs and Medical Devices offers the latest version of the reliable SARS-CoV-2 antigen rapid test.
Contact
HANGZHOU ALLTEST BIOTECH CO.,LTD
550 Yinhai street, Hangzhou Economic and Technologic Development Area 310018, PR China
Web: http://www.alltests.com.cn/