FDA released a list of coronavirus antibody tests that FAIL to meet accuracy standards and it cracks down on nearly 200 unvetted products
US regulators said 27 vendors can no longer sell their coronavirus antibody test as part of the Food and Drug Administration's (FDA) crackdown on scores of blood tests that have not yet been shown to work. The FDA on Thursday, May 21, 2020 published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products.
There are tests on the market that do not work as claimed and sadly, some sellers are price gouging in this pandemic crisis. The following serological tests had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have now been removed from that notification list. (Updated 5/22)
Artron BioResearch Inc./Artron Laboratories Inc. COVID-19 IgM/IgG Antibody Test*
BestNovo (Jiangsu)Medical Technology Co., Ltd. BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit
Biobase Biodustry(Shandong) Co., Ltd. SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
BioMedomics, Inc.COVID-19 IgM-IgG rapid test*
Bioscience(Chongqing)Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for NovelCoronavirus (2019-nCoV) IgM Antibody
Bioscience(Chongqing)Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for NovelCoronavirus (2019-nCoV) IgG Antibody
Bioscience(Tianjin)Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for NovelCoronavirus(2019-nCoV) IgM Antibody
Bioscience(Tianjin)Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for NovelCoronavirus(2019-nCoV) IgG Antibody
Boson Biotech Ltd. Co (Distributedby Pure Genetic Medical Ltd.) Rapid 2019-nCoV IgG/IgM Combo Test Card
Changchun WanchengBio-Electron Co., Ltd. COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal goldimmunochromatography)
Diazyme Laboratories,Inc. Diazyme SARS-CoV-2 Antibody Rapid Test*
Genlantis Diagnostics,Inc. CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test*
Hangzhou Clongene BiotechCo., Ltd. COMBRA COVID-19 IgM/IgG Rapid Test Cassette
Hangzhou TestseaBiotechnology Co., Ltd. One Step SARS-CoV2(COVID-19) IgG/IgM Test*
Hunan RunKunPharmaceutical Co., Ltd. SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold)*
IMMY, Inc. clarusSARS-CoV-2 Total Antibody EIA*
Jiangsu EuboBiotechnology Co., Ltd. EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
Lifeassay Test-itCOVID-19 IgM/IgG Lateral Flow Assay
Phamatech COVID19 IgG /IgM Rapid Test*
Promedical COVID-19 RapidTest
Saladax BiomedicalCOVID-19 IgG/IgM Rapid Antibody Test*
Shanghai Eugene BiotechCo., Ltd. SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
Shenzen Landwind MedicalCo., Ltd. COVID-19 IgG/IgM Rapid Test*
VITA Testing COVID-19IgM/IgG Antibody Rapid Test Kit
Zhengzhou FortuneBioscience Co., Ltd. COVID-19 Antibody Rapid Test Kit (Colloidal GoldImmunochromatography Method)
Zhengzhou FortuneBioscience Co., Ltd. COVID-19 IgM Antibody Rapid Test Kit
Zhengzhou FortuneBioscience Co., Ltd. COVID-19 IgG Antibody Rapid Test Kit
Zhongshan Bio-Tech CoLtd. SARS-CoV-2 IgM/IgG (GICA)*
Correctly identifying coronavirus antibodies requires a test to be both 'specific' and 'sensitive.' The more specific an antibody test is, the less likely it is to incorrectly identify antibodies developed to fight a different infection instead of those developed in response to SARS-CoV-2, the virus that causes COVID-19. Sensitivity is a measure of how likely a test is to pick up antibodies when they're present.
Amplicon independently validates all COVID19 IgM/IG Rapid Tests offered. In business since 1996, Amplicon proactively performs investigational research to confirm the claims of all manufacturers. Doing our due diligence is a critical part of bringing the best performing tests to Medical Professionals.
If an EUA request is not submitted by a commercial manufacturer of a serology test, or if significant problems are identified with such a test, the FDA removes the manufacturer and test from the notification list. FDA expects that the tests on this list will not be distributed.
This is where AMPLICON comes in. AMPLICON helps alleviate these concerns by independently testing the kits to make sure Clinics and Medical Professionals can trust the product inserts and the manufacturer claims of sensitivity, accuracy and specificity. When bad manufacturers are making spurious tests, our independent analysis will quickly detect and the manufacturer/distribution networks are immediately reported to the FDA.
Amplicon's OrientGene Product has been FDA EUA Authorized. Read more here.