FDA Watch

Agency Sounds the Warning on False-Positives from Becton Dickinson SARS-CoV-2 Reagents

On July 6, the U.S. Food and Drug Administration (FDA) issued a warning letter alerting clinical laboratory staff and providers of the increased risk of false-positive results from Becton Dickinson (BD) BD SARS-CoV-2 reagents for its BD Max System test.

The Warning Letter

If you are currently using the reagents for the BD Max System and get a positive result, the FDA recommends that you treat the result as presumptive and consider confirming it with another authorized test. The warning letter also calls on laboratory staff and providers to report any issues with using COVID-19 tests.

The FDA granted Emergency Use Authorization (EUA) for the BD PCR-based SARS-CoV-2 kit on April 8. The test, which detects viral nucleic acid from SARS-CoV-2 in upper respiratory specimens, was cleared for moderate- and high-complexity testing laboratories on the BD Max System using BD reagents. However, the company began receiving reports of the potential for false positives when the test was used with the reagents, including one study in which a manufacturer found that approximately 3 percent of results were false positives.

Even though the users citing accuracy concerns represented a small subset of overall true-positive results, the firm approached the FDA to discuss the problems and go over the options to improve test performance, according to a BD spokesperson. The FDA is currently working with the firm to resolve the issue and promises to provide new or additional information as the situation develops.

Takeaway

Accuracy and the risk of false positives generated by EUA COVID-19 serology tests has been an ongoing concern. However, the BD test is a molecular PCR-based assay which are generally considered more accurate and reliable than serology-based antibody tests. Even so, the BD situation seems to be a bit of an outlier limited to a particular PCR product using a particular reagent on a particular platform.


Here are some of the key new FDA EUAs and clearances announced in July:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
DiaCarta EUA for QuantiVirus SARS-CoV-2 Multiplex Test Kit
Becton Dickinson (BD) Premarket approval supplement for expanded BD Onclarity HPV Assay
BD EUA for SARS-CoV-2 antigen test
Paige 510(k) clearance for use of FullFocus digital pathology image viewer with Philips Ultra Fast scanner for primary diagnosis
Access Genetics EUA for OraRisk COVID-19 RT-PCR test
Megna Health EUA for Rapid COVID-19 IgM/IgG Combo Test Kit (serology)
Luminex EUA for xMap SARS-CoV-2 Multi-Antigen IgG Assay
Boston Heart Diagnostics EUA for Boston Heart COVID-19 RT-PCR Test
Quest Diagnostics Expanded EUA for SARS-CoV-2 RNA test for sample pooling use
Quest Diagnostics

EUA for 3 coronavirus assays:
*PF SARS-CoV-2 Assay performed with Hologic’s Panther Fusion SARS-CoV-2 RT-PCR-based test
*RC SARS-CoV-2 Assay performed with Roche automated Cobas SARS-CoV-2 RT-PCR test
*HA SARS-CoV-2 Assay

KogeneBiotech EUA for PowerChek 2019-nCoV Real-time PCR Kit
Trax Management EUA for PhoenixDx SARS-CoV-2 Multiplex
Beijing Wantai Biological Pharmacy EUA for SARS-CoV-2 Ab Rapid Test lateral flow serology assay
Diazyme Laboratories EUA for Diazyme DZ-Lite SARS-CoV-2 IgG antibody test
BioSewoom EUA for Real-Q 2019-nCoV Detection Kit
Enzo Life Sciences EUA for Ampiprobe SARS-CoV-2 Test System
Access Bio EUA for CareStart COVID-19 MDx RT-PCR test
Gene By Gene EUA for RT PCR-based SARS-CoV-2 Detection Test
Saladax Biomedical De novo clearance for MyCare Psychiatry Clozapine Assay rapid blood test for clozapine levels in psychiatric patients
Assure Tech EUA for Assure COVID-19 IgG/IgM Rapid Test Device
US Centers for Disease Control and Prevention EUA for Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay real-time RT-PCR test for simultaneous detection and differentiation of SARS-CoV-2, influenza A and influenza B
Centogene EUA for PCR-based SARS-CoV-2 test
InBios International EUA for SCoV-2 Detect IgM ELISA kit (serological)
3B Blackbio EUA for Biotech India COVID-19 test
Bioperfectus Technologies EUA for COVID-19 Coronavirus Real Time PCR Kit to detect SARS-CoV-2 ORF1ab and N genes
Omnipathology Solutions EUA for Omni COVID-19 ASSAY by RT-PCR
Biohit Healthcare EUA for SARS-CoV-2 IgM/IgG Antibody Test Kit
ADS Biotec EUA for SARS-CoV-2 Antibody Detection Kit
Ohio State University EUA for OSUWMC COVID-19 RT-PCR test
Thermo Fisher Scientific Breakthrough Device Designation for Oncomine Precision Assay to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 mutations eligible for treatment with vorasidenib
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