SARS-CoV-2 Tests For 2022

SARS-CoV-2 Coronavirus Tests For 2022

As of June 7, 2022, the U.S. Food and Drug Administration (FDA) confirmed it had authorized 438 tests and sample collection devices under emergency use authorizations (EUAs). And the FDA has also authorized 996 revisions since the COVID-19 pandemic began in early 2020.

The FDA updated the Antibody Testing for COVID-19: Information for Patients and Consumers. And the question and answer resources: COVID-19 Test Development and Test Uses: updated on Mar. 18, 2022.

On June 8, 2022, the ECDC issued guidance on scaling up capability and capacity to characterize SARS-CoV-2 variants. Previously, the WHO issued interim guidance on using SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing.

At-Home OTC COVID-19 Diagnostic Test

According to the CDC's report on March 25, 2022, there was a rapid increase in at-home test use between the SARS-CoV-2 Delta- and Omicron-predominant periods. And on May 16, 2022, the government confirmed every home in the U.S. is eligible to order the 3rd round of free at-home tests.

On April 29, 2022, the JAMA Network published: Comparison of Home Antigen Testing With RT-PCR and Viral Culture During SARS-CoV-2 Infection and a Research Letter in January 2022: False-Positive Results in Rapid Antigen Tests for SARS-CoV-2. The overall rate of false-positive results among the total rapid antigen test screens for SARS-CoV-2 was very low.

SARS-CoV-2 Diagnostic Test Panels

Diagnostic testing analyzes the qualitative detection of nucleic acid from the COVID-19 disease in upper and lower respiratory specimens such as nasal swabs, throat swabs, and, if possible, sputum collected from individuals who meet COVID-19 clinical and/or epidemiological criteria.

Nucleic acid amplification tests are molecular tests that detect the virus's genetic material collected from the patient.

SARS-CoV-2 Serological Antibody Test

Antibody testing is essential to tell if someone has been previously infected. In addition, it will provide more understanding of the coronavirus, including how long antibodies stay in the body. However, if they provide immunity, there is no identified advantage of assays on whether they test for IgG, IgM, IgG, or total antibody, says the CDC. The serology or antibody test measures the number of antibodies present in the blood when the body responds to a specific infection, like SARS-CoV-2.

SARS-CoV-2 Lateral Flow Tests

Lateral flow tests (LFTs) can tell you if you're infected with COVID-19 within minutes, rather than waiting 24-48 hours for the results of a PCR test. A recent Cochrane Review (March 2021) combined the results of multiple studies assessing the accuracy of LFTs and found that the average sensitivity of such tests was 72% among people with COVID-19 symptoms and 58% for people without symptoms.

SARS-CoV-2 Combination Tests

On May 16, 2022, the U.S. FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19.

The U.S. FDA assists healthcare providers in preparing for the 2020-2021 flu season during the COVID-19 pandemic by issuing emergency use authorizations for diagnostic tests to detect and differentiate the viruses that cause COVID-19 disease and influenza. While the seasonal Flu and COVID-19 are both contagious respiratory illnesses, unlike viruses that cause them, says the CDC.

SARS-CoV-2 Testing News For 2022

May 17, 2022 - BMJ Global Health published Original research: Scent dogs in the detection of COVID-19: a triple-blinded randomized trial and operational real-life screening in an airport setting - the accuracy of the dogs in identifying the samples was 92%.

May 13, 2022 - The U.S. CDC confirmed about 867 million COVID-19-related test results had been reported since the pandemic began in 2020.

April 14, 2022 - The U.S. FDA authorized the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

April 7, 2022 - The U.S. FDA announced two OTC at-home COVID-19 antigen tests. Emergency use authorizations were issued to Osang LLC for their OHC COVID-19 Antigen Self-Test, and Xiamen Boson Biotech Co., Ltd for their Rapid SARS-CoV-2 Antigen Test Card.

April 5, 2022 - KSL Diagnostics, Inc. announced the first-of-its-kind COVID-19 Immune Index™ that detects an individual’s immune response to COVID-19 and assesses the risk of infection if subsequently exposed.

March 18, 2022 - The JAMA Network published Comparative Effectiveness of Single vs. Repeated Rapid SARS-CoV-2 Antigen Testing Among Asymptomatic Individuals in a Workplace Setting. This study demonstrated that when a repeated rapid antigen test was offered to participants of an employee screening program, the estimated accuracy increased from 38% to 92% for true-positive results as determined by RT-qPCR for SARS-CoV-2.

March 18, 2022 - The FDA issued a safety communication to alert people of the potential for harm if FDA-authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions.

March 16/17, 2022 - The FDA issued a Class I Recalls for SD Biosensor STANDARD Q COVID-19 Ag Home Test and the Celltrion DiaTrust COVID-19 Ag Rapid Test.

March 11, 2022 - The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.

March 7, 2022 - Walgreens and Labcorp announced the nationwide availability of Pixel by Labcorp® COVID-19 at-home collection kit, a PCR test available through Labcorp OnDemand™ at no cost to individuals who meet clinical guidelines. Walgreens kits are provided in collaboration with the U.S. Department of Health and Human Services, which will enable more communities to access reliable, convenient testing services.

February 28, 2022 - This non-peer-reviewed study represents a non-pre-specified analysis in which we sought to determine if the sensitivity of Ag-RDT differed in participants with Delta compared to the Omicron variant. The performance of Ag-RDT is not inferior to the Omicron variant compared to the Delta variant. Furthermore, the improvement in sensitivity of Ag-RDT with serial testing is consistent between Delta and Omicron variants.

February 8, 2022 - The journal Nature Scientific Reports published a validation study of Quest Diagnostic's highly automated SARS-COV-2 variant whole genome sequencing technique. Validation studies demonstrated that the optimized workflow can process up to 2688 samples in a single sequencing run without compromising sensitivity and accuracy and with fewer amplicon dropout events compared to the standard ARTIC protocol.

February 4, 2022 - The U.S. FDA is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the U.S. In addition, it may include false labeling representing that the FDA authorizes the test. The E25Bio COVID-19 Direct Antigen Rapid Test may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.

January 31, 2022 - A study published in The JAMA Internal Medicine indicates that people using COVID home test kits may fail to self-quarantine or be unnecessarily quarantined when misinterpreting test results.

SARS-CoV-2 Testing News For 2021

To review SARS-CoV-2 testing news For 2021, please visit this webpage.

Note: If you think you have COVID-19 and need a test, contact your healthcare provider immediately. Or, contact your local health department regarding questions about testing. The FDA's COVID-19 Industry Hotline (1-888-INFO-FDA, press *) addresses questions on topics such as diagnostic testing. If you received a COVID-19 vaccination, be aware that if you have a positive test result on a SARS-CoV-2 antibody test, it is possible you were previously infected with SARS-CoV-2. A COVID-19 vaccination may also cause a positive antibody test result for some but not all antibody tests.

The information is sourced from various organizations such as the CDC, NIH, WHO, and the Precision Vax news network.