Almost from the moment the pandemic began, high throughput testing for use in mass screening has occupied a high place on the FDA’s coronavirus diagnostics priority list. On Jan. 12, 2021, Ortho Clinical Diagnostics announced that it has received FDA emergency use authorization (EUA) for what it claims is the first high-volume SARS-CoV-2 antigen test cleared for such use.
The Vitros SARS-CoV-2 Antigen Assay Ortho’s Vitros SARS-CoV-2 Antigen test is well positioned to meet the need for mass screening because it runs on the firm’s high-volume Vitros systems (namely, the Vitros 3600 Immunodiagnostic and Vitros 5600/XT 7600 Integrated systems) that are installed in more than 5,600 labs worldwide, including 1,500 in the U.S. These systems are capable of running up to 130 of the newly cleared Vitros SARS-CoV-2 tests per hour, according to the Raritan, N.J.-based firm. Unlike most antigen tests which detect the virus samples of blood and bodily fluids, the Ortho test can be used on swabs collected in accordance with the U.S. Centers for Disease Control and Prevention’s (CDC) formulation of viral transport media (VTM), Copan Universal Transport Media, Remel M4RT VTM or Hard R99 VTM. Samples can be collected in bulk, stored at room temperature for up to 24 hours (or 48 hours with refrigeration). Ortho claims that the antigen test is a viable alternative to RT-PCR for people with known or suspected exposure to SARS-CoV-2 or who are displaying symptoms suggestive of infection. With 97.8 percent sensitivity and 99.2 percent specificity, the test “offers exceptional utility for mass-scale testing where appropriate,” according to a company statement.
Next Steps for Ortho Ortho has established itself in the non-RT-PCR coronavirus assay market in the U.S. and globally. The Vitros antigen assay received CE clearance for use in Europe in October. Shortly after, the firm scaled up production in the U.K. Now that the test has received EUA, the company expects to step up production out of its Rochester, N.Y., manufacturing facility. The antigen test expands the Ortho COVID-19 product portfolio which includes a pair of antibody tests that have both received CE marking in Europe and FDA EUA clearance in the U.S. One test detects total antibodies to SARS-CoV-2 and the other detects IgG antibodies. The firm has also received a $12.9 million grant from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to develop its trio of SARS-CoV-2 tests. Ortho said that it currently can deliver 5 million tests per month and that it will be able to increase that figure to 15 million tests per month in February. Here are the other key new FDA EUAs and international clearances announced in January 2021:
New FDA Emergency Use Authorizations (EUAs) & Approvals | Manufacturer(s) | Product |
|---|
| Ambry Genetics | EUA for Ambry COVID-19 RT-PCR Test |
| Bio-Rad Laboratories | EUA for Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay |
| United Biomedical | EUA for UBI SARS-CoV-2 ELISA antibodies test |
| SML Genetree | EUA for Ezplex SARS-CoV-2 G Kit |
| Ortho Clinical Diagnostics | Vitros SARS-CoV-2 Antigen test, first high-volume COVID-19 antigen test to get EUA |
| Phadia (Thermo Fisher Scientific subsidiary) | EUA for EliA SARS-CoV-2-Sp1 IgG Test fluoro-enzyme immunoassay |
| Abbott | 510(k) clearance for rapid handheld blood test for traumatic brain injury |
| Helix | de novo clearance for Helix Laboratory Platform, first whole-exome sequencing platform to get FDA clearance |
| Helix | 510(k) clearance for Helix Genetic Health Risk App (HRA) DTC genetic test for late-onset Alzheimer’s |
| Siemens Healthineers | EUA for Dimension Vista SARS CoV 2 IgG (COV2G) antibodies immunoassay |
| Siemens Healthineers | EUA for lab-based IL-6 assay to measure presence of interleukin-6 in human serum or plasma |
| Advaite | EUA for RapCov Rapid COVID-19 Test point of care serology test |
| Quanterix | EUA for Simoa SARS-CoV-2 N Protein Antigen Test |
| Nirmidas Biotech | EUA for MidaSpot COVID-19 Antibody Combo Detection Kit point of care test |
| Roche | EUA for Elecsys Anti-SARS-CoV-2 S electrochemiluminescence immunoassay run on firm’s Cobas E analyzers |
| Lucira Health | EUA for Lucira COVID-19 All-in-One Test Kit, first fully at-home test authorized for COVID-19 |
| GenScript Biotech | EUA for cPass SARS-CoV-2 Neutralization Antibody Detection Kit, first SARS-CoV-2 neutralizing antibody test to receive EUA |
New CE Marks & Global Certifications Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE| Manufacturer(s) | Product(s) |
|---|
| Fluidigm | Advanta Dx SARS-CoV-2 RT-PCR assay |
| Abbott | Panbio COVID-19 Ag Rapid Test Device for mass screening of the asymptomatic and self-swabbing |
| Actim | Actim ELISA SARS-CoV-2 IgG assay |
| Chembio Diagnostics | DPP SARS-CoV-2 Antigen and IgM/IgG test systems |
| Biomerica | COVID-19 Rapid Antigen Test |
| Theradiag | 4 biotherapy monitoring test kits run on firm’s i-Track 10 system and Immunodiagnostic Systems’ IDS-iSYS automated analyzer: *i-Tracker Vedolizumab
*i-Tracker Anti-Vedolizumab
*i-Tracker Ustekinumab
*i-Tracker Anti-Ustekinumab |
| Snibe Diagnostic | Maglumi SARS-CoV-2 Neutralizing Antibody Assay |
| Spectrum Solutions | Two SDNA saliva collection devices for molecular testing |
| Trinity Biotech | Captia SARS-CoV-2 IgG ELISA test |
| Shuwen Biotech | SARS-COV-2 RT-PCR Kit |
| Sona Nanotech | Rapid SARS-CoV-2 antigen test |
| BioPorto | NGALds point-of-care kidney injury test |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
|---|
| LumiraDx | Japan | SARS-CoV-2 Antigen test |
| LumiraDx | Brazil | SARS-CoV-2 Antigen test |
| DNA Genotek (OraSure Technologies subsidiary) | Canada | OMNIgene ORAL (OME-505) saliva collection device for use in SARS-CoV-2 molecular testing |
| MiRxes | Singapore | Multiplex SARS-CoV-2 and influenza A/B test |
| Excalibur Healthcare Services | U.K. | Rapid SARS COV-2 Antigen Screening test |
| GNA Biosolutions | Germany | Octea SARS-CoV-2 batch testing system |
