FDA Watch

Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks

Shortages of the nasopharyngeal swabs used to collect respiratory samples for reverse transcription polymerase chain reaction (RT-PCR) tests has impeded the efforts of laboratories to meet the unprecedented demands for COVID-19 testing. So, the August 15 announcement that a saliva-based from the Yale School of Public Health has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) is welcome news.

The Yale SalivaDirect test uses a new sample processing method allowing for collection of saliva samples in a sterile container, eliminating the need for nasopharyngeal swabs. The method also cuts out the separate nucleic acid extraction step, for which kits have also been in short supply. SalivaDirect allows for dualplex RT-qPCR method testing of low volumes of saliva treated with proteinase K followed by a heat inactivation. While the EUA allows for laboratories designated by the Yale School of Public Health, Yale will provide the SalivaDirect protocol freely to interested laboratories. “Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” noted FDA Commissioner Stephen Hahn in a statement.

SalivaDirect is the fifth saliva test for SARS-CoV-2 to receive EUA from the FDA. The others are produced by (in order of EUA issuance):

  • Rutgers Clinical Genomics Laboratory, with the original April EUA expanded in May to allow for at-home collection;
  • Phosphorous Diagnostics;
  • P23 Labs; and
  • Clinical Reference Laboratory.

Here are other key new FDA EUAs and clearances announced in August:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
LumiraDx EUA for LumiraDx SARS-CoV-2 Ag Test (third antigen test authorized for SARS-CoV-2)
LumiraDx EUA for LumiraDx SARS-CoV-2 RNA STAR assay
Sinochips Bioscience EUA for COVID-19 Nucleic Acid RT-PCR Test Kit
BioCheck EUA for BioCheck SARS-CoV-2 IgM and IgG Combo Test (serology)
23andMe 510(k) clearance for CYP2C19 Drug Metabolism Report, informing customers if their genotypes may influence their ability to respond to clopidogrel and citalopram without need for confirmatory testing
Diazyme Laboratories EUA for Diazyme DZ-Lite SARS-CoV-2 IgM test (serology)
Biomeme EUA for SARS-CoV-2 Real-Time RT-PCR Test
Solaris Diagnostics EUA for Solaris Multiplex SARS-CoV-2 Assay
Alpha Genomix Laboratories EUA for TaqPath SARS-CoV-2 Combo Assay based on Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo Kit
George Washington University EUA for GWU COVID-19 RT-PCR test
BioMérieux EUA for Vidas SARS-CoV-2 IgM test used with firm’s Vidas SARS-CoV-2 IgG test (serology)
Beijing Wantai Biological Pharmacy EUA for Wantai SARS-CoV-2 Ab ELISA test (serology)
Helix EUA for next-generation sequencing-based test to detect SARS-CoV-2 spike protein gene
Guardant Health Clearance for Guardant360 CDx, targeted next-generation sequencing liquid biopsy assay, for tumor mutation profiling in advanced cancer patients with solid malignant neoplasm
Adaptive Biotechnologies Expanded clearance for its clonoSeq assay to assess minimal residual disease in patients with chronic lymphocytic leukemia
Roche Clearance for Cobas Epstein-Barr Virus test
Quest Diagnostics EUA for technique that speeds extraction of viral RNA from patient samples
Eli Lilly and Company EUA for Lilly SARS-CoV-2 Assay
Sandia National Laboratories EUA for SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay
Xiamen Biotime Biotechnology EUA for Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test, serology assay detecting and IgG and IgM antibodies
LabCorp Reissued EUA for COVID-19 RT-PCR Test for testing asymptomatic patients and pooled sample testing
CoWin Biotech EUA for Novel Coronavirus Fast Nucleic Acid Detection Kit run on Thermo Fisher’s Applied Biosystems 7500 RT-PCR system
Helix OpCo EUA for Helix COVID-19 Test detecting SARS-CoV-2 nucleocapsid, ORF1ab and spike protein genes
Thermo Fisher Scientific Clearance for ImmunoCAP Specific IgE alpha-Gal Allergen Component blood test detecting sensitization to alpha-gal carbohydrate in red meat and assessing risk for an anaphylactic reaction

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