The US Centers for Disease Control and Prevention (CDC) Data Tracker reported over 404 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm SARS-CoV-2 virus infections as of April 22, 2021.
Recent data compiled by Statista on April 6, 2021, indicates the USA leads all other counties in COVID-19 tests processed. Followed by India (250m) and China (160m).
As of April 20, 2021, the U.S. Food and Drug Administration (FDA) announced it had authorized 367 coronavirus diagnostic tests, including 269 molecular tests, 75 antibody tests, and 23 antigen tests during the COVID-19 pandemic. Furthermore, 49 molecular authorizations can be used with home-collected samples.
The FDA recently published A Closer Look at COVID-19 Diagnostic Testing to offer those who might purchase COVID-19 tests more technical information and resources. The COVID-19 tests most people discuss are RT-PCR, the nasal-swab test that detects viral RNA, and various antibody tests that detect if you have an immune response due to past exposure to the SARS-CoV-2, the beta coronavirus that causes COVID-19.
On January 29, 2021, the World Health Organization (WHO) published its yearly essential diagnostics list: WHO Technical Report Series, No. 1031, 2021, which includes WHO-recommended COVID-19 tests (PCR and Antigen), expands the suite of tests for vaccine-preventable and infectious diseases and non-communicable diseases (such as cancer, diabetes), and introduces a section on endocrinology, which is important for reproductive and women’s health.
The U.S. FDA published on March 16, 2021, steps to streamline the path for COVID-19 screening tools and provides information to help groups establishing testing programs. Additionally, the FDA issued a fact sheet that outlines considerations for selecting a test for use in a screening testing program. The fact sheet will help schools, workplaces, communities, and other locations as they select a test for screening and understand the difference between tests used to diagnose suspected COVID-19 compared to those used for screening asymptomatic individuals.
On March 17, the ECDC outlined the public health considerations for the use of self-tests to detect SARS-CoV-2 by public health authorities in the European Union/European Economic Area. Only rapid antigen detection tests for self-testing for direct detection of SARS-CoV-2 virus particles in infectious individuals are considered within this document.
On March 19, 2021, the FDA announced a new web page on FDA.gov, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs. This resource is intended for schools, workplaces, communities, and others looking to establish testing programs to screen people without symptoms and with no known or suspected exposure to COVID-19.
This FDA page provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and health care providers, and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations.
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 Test
Antibody testing is an important step to tell if someone has been previously infected. It will provide more understanding of the coronavirus, including how long antibodies stay in the body and if they provide immunity. There is no identified advantage of assays whether they test for IgG, IgM, and 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 Combination Tests
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, but unlike viruses cause them, says the CDC.
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.
April 2021 SARS-CoV-2 Diagnostic Test News
April 19, 2021 - Illinois-based Walgreens announced it has entered into an agreement with Abbott to sell the BinaxNOW™ Rapid Antigen Self Test over-the-counter in Walgreens stores nationwide. The test will be available for purchase in-store, curbside pick-up, and fame-day delivery for $23.99 (MSRP).
April 12, 2021 - Lucira Health, Inc. announced the U.S. FDA issued an Emergency Use Authorization for over-the-counter sale of the LUCIRA CHECK IT™ test kit that delivers PCR quality molecular accuracy in 30 minutes or less at home. It is authorized and available for individuals with or without symptoms and can be ordered from lucirahealth.com for $55.
April 5, 2021 - The U.S. FDA issued an Emergency Use Authorization to Symbiotica, Inc. For the COVID-19 Self-Collected Antibody Test System, making it the first serology test authorized for use with a blood sample self-collected at home.
April 5, 2021 - Kentucky-based Ethos Laboratories announced the validation of a high-throughput molecular test for the detection of key SARS-CoV-2 virus strains, including the UK (B.1.1.7), South Africa (B.1.351), Brazil (P.1) variants. These variants have been estimated to account for 40 percent of new infections in certain areas of the United States, making their accurate detection critical for ongoing public health strategies. Current genomic surveillance of SARS-CoV-2 variants is conducted using gene-sequencing technologies, which are not amenable to high-throughput testing; the CDC indicates that the time required to sequence a sample and submit findings into public databases is approximately 10 days. While such sequencing technologies will be critical for identifying new SARS-CoV-2 variants as they emerge worldwide, there is a significant need for high-throughput technologies capable of accurately detecting known or existing variants.
April 1, 2021 - EUROIMMUN, a PerkinElmer, Inc. Company, announced the launch of the SARS-CoV-2 NeutraLISA assay, a surrogate neutralization test intended for the detection of neutralizing antibodies against SARS-CoV-2, the pathogen causing COVID-19. The CE-marked assay adds to the Company’s broad portfolio of COVID-19 diagnostics and is currently available in more than 30 countries that accept the CE mark.
April 1, 2021 - Toronto-based SQI Diagnostics Inc. announced that it had submitted its fully completed clinical and analytical data package to the U.S. Food and Drug Administration for emergency use authorization (EUA) RALI-Dx ™ IL-6 Severity Triage Test. Subject to the acceptance of a EUA, the RALI-Dx ™ IL-6 Severity Triage Test is intended to be utilized by hospital emergency departments and labs to help clinicians identify severe inflammatory responses in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation.
March 2021 SARS-CoV-2 Diagnostic Test News
March 31, 2021 - Abbott announced today it had received U.S. Food and Drug Administration Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW™ COVID-19 Ag Self Test for detection of COVID-19 infection. This new indication allows individuals with or without symptoms to have access to this test without a prescription. Abbott will begin shipping to major food, drug, and mass merchandiser retailers in the coming weeks and expect the test to be available through some of their online store websites.
March 31, 2021 - The U.S. FDA authorized three tests with serial screening claims (testing asymptomatic individuals multiple times on a routine basis). Specific tests authorized this week: Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening; Abbott BinaxNOW (multiple configurations); Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening; Abbott BinaxNOW COVID-19 Ag Card 2 Home Test - authorized for OTC at-home serial screening with telehealth proctor; Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription; and BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription.
March 30, 2021 - Texas Governor Greg Abbott and the Texas Division of Emergency Management (TDEM) today announced creating a COVID-19 Rapid Testing Program for Texas youth summer camps. This program will help summer camps licensed by the Texas Department of State Health Services (DSHS) to conduct rapid tests of staff and campers during the summer months.
March 25, 2021 - Amazon.com Services LLC.'s subsidiary STS Lab Holdco has received an emergency use authorization (EUA202760) from the US Food and Drug Administration for a Covid-19 test kit Real-Time RT-PCR Test for Detecting SARS-CoV-2. This test is authorized for the following indications for use: Qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected by any individuals (18 years of age or older), including individuals without symptoms or other reasons to suspect COVID-19, using either (1) under the supervision of a healthcare provider or, (2) the unsupervised at home.
March 24, 2021 - New York-based LetsGetChecked announces the Food and Drug Administration (FDA) authorization of its Coronavirus home collection test now available without a prescription.
March 23, 2021 - California-based Beckman Coulter announced that its Access SARS-CoV-2 IgG II antibody assay received an Emergency Use Authorization from the U.S. Food and Drug Administration. The semi-quantitative assay measures a patient’s level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units. Lenco Diagnostic Laboratories, one of New York City’s largest privately-owned, full-service reference labs, is among the first to offer the test in its facilities across Brooklyn, NYC, and the tri-state metropolitan area. Lenco conducted an independent verification of the assay’s performance and is highly satisfied with the quality of the results.
March 23, 2021 - The U.S. FDA issued an emergency use authorization to the Twist Bioscience Corporation for their SARS-CoV-2 NGS Assay. The SARS-CoV-2 NGS Assay is a next-generation sequencing-based test for identifying SARS-CoV-2 RNA from respiratory samples, such as the nose or throat swabs and washes, from people who are suspected of having COVID-19.
March 22, 2021 - Eurofins Technologies announces its GSD NovaType II launch, its upgraded RT-PCR kit to identify mutations associated with SARS-CoV-2 variants of concern. The first GSD NovaType RT-PCR kit was launched in February 2021 and quickly supported health authorities in detecting variants in more than 100,000 COVID-19 positive patients across Europe. The new GSD NovaType II kit can now detect the N501Y and E484K mutations common to most VOC (Variants Of Concern) and the K417N mutation (specific to B.1.351 first identified in South Africa), with high sensitivity. The GSD NovaType II kit delivers results in under two hours. It is, therefore, well suited to timely screening and relieving sequencing capacities for use in epidemiological studies.
March 19, 2021 - The U.S. Food and Drug Administration issued an emergency use authorization for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).
March 17, 2021 - The U.S. FDA granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The grant of this De Novo request marks an important step in FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.
March 17, 2021 - USA's Administration to Invest More Than $12 Billion to Expand COVID-19 Testing.
March 16, 2021 - Study published by PLOS: Accurate point-of-care serology tests for COVID-19. Conclusions - Finger-stick, POC COVID-19 antibody testing, was highly effective in identifying antibodies resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection and should be useful in assessing vaccine response.
March 15, 2021 - Pelican Diagnostics, a Canary Global Inc. company, has received CE Mark for a 25-second COVID-19 saliva test, delivering real-time results with 98% sensitivity and 100% specificity. The Pelican COVID-19 Ultra-Rapid Mobile Test for detecting SARS-CoV-2 is now cleared for sale and distribution in the European Union. The test is also under review at the U.S. Food and Drug Administration under Emergency Use Authorization for Over-the-Counter, non-prescription use, and as a self-test.
March 12, 2021 - The U.S. Food and Drug Administration alerted clinical laboratory staff, point-of-care facility staff, and health care providers that false-positive results can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. The false-positive results may be related to two issues observed by Roche. False-positive results may also lead to unnecessary isolation and additional health monitoring, delayed diagnosis and treatment, and misallocation of resources used for surveillance and prevention for other infections or health conditions. Generally, the test is designed to detect and differentiate viral nucleic acid from SARS-CoV-2, the virus that causes COVID-19, influenza A, and B viruses, in upper respiratory specimens, such as nasal swabs, from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.
March 10, 2021 - empowerDX, a Eurofins (Paris: ERF) subsidiary, announced the launch of its direct-to-consumer, FDA-emergency use authorized COVID-19 Home Collection Kit on Amazon. The kits are available to consumers and businesses for purchase without a prescription, enabling greater access to COVID-19 tests to fight against the pandemic. The empowerDX at-home COVID-19 test can detect the virus in both symptomatic and asymptomatic patients. Eurofins Viracor, an infectious disease testing laboratory for more than 35 years, developed the empowerDX test based on its own FDA EUA authorized SARS-CoV-2 RT-PCR assay. That assay offers one of the best sensitivity rates of the 117 tests submitted to the FDA SARS-CoV-2 Reference Panel1.
March 5, 2021 - The U.S. Food and Drug Administration issued an emergency use authorization for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next-generation sequencing-based test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.
March 5, 2021 - The U.S. FDA issued an emergency use authorization for the Cue COVID-19 Test for Home and Over The Counter Use. The product is a molecular nucleic acid amplification test intended to detect genetic material from the SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized by the FDA for at-home use without a prescription.
March 2, 2021 - Quest Diagnostics Marks 1-Year of COVID-19 Molecular Diagnostic Testing and More Than 40 Million COVID-19 Tests.
March 1, 2021 - The U.S. Food and Drug Administration issued an emergency use authorization for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home without needing to send a sample to a laboratory for analysis. The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
Previous Diagnostic Test News Is Available At This Link
NOTE: The information is sourced from organizations such as the CDC, NIH, WHO, and the Precision Vax news network and reviewed by Dr. Robert Carlson.