DiaCarta’s COVID-19 Test Ranks Top 10 Among All FDA EUA Tests Based on Limit of Detection
Richmond, California, September 2, 2020.
Based on evaluation of all the FDA EUA approved kits before July 27, 2020, DiaCarta’s QuantiVirusTM SARS-CoV-2 Multiplex Test ranks among the top 10 kits in terms of low limit of detection (LoD). DiaCarta is the top 6 company, after Perkin Elmer, Roche, Quest, RTA and BD Biosciences. The QuantiVirusTM SARS-CoV-2 Test, another RT-qPCR-based DiaCarta kit granted with FDA EUA, is top 20 on the list. The evaluation was conducted by MacKay et al. in Nature Biotechnology published on August 20.
Why is low LoD a big deal? According to Arnaout R et al., for every 10-fold increase in LoD, there is a 13% increase in false-negativity. This means tests with higher LoD significantly lower the test sensitivity, although clinical sensitivity and specificity are both over 95% for all 157 tests on the list. Surprisingly, the LoD for these tests spans 5 orders of magnitude from 0.009 to more than 100 copies per mL of sample.
“We are proud to have two viral RNA tests approved by the FDA EUA and CE-marked, both of which are highly sensitive,” Said Dr. Ramanathan Vairavan, Senior Vice President, Commercial Operations at DiaCarta, Inc. “These tests are critical for COVID-19 infection screening as we reopen the economy.”
In addition, DiaCarta has also developed the QuantiVirusTM Anti-SARS-CoV-2 IgG test, which is also filed with FDA and is CE-marked. This sensitive antibody test, once approved by FDA EUA, will add great value identifying potential blood donors for COVID-19 plasma therapy authorized by FDA EUA on August 23, although the risk reduction from the therapy may be relative rather than absolute, according to Dr. Steven Hahn, the FDA commissioner.
To help speed up COVID-19 screening, DiaCarta has validated these tests at our own CLIA lab. With three types of sample collection kits available (nasal, oral, and saliva), DiaCarta offers seamless COVID-19 testing services for healthcare providers, public health departments, businesses, and schools.
DiaCarta is a molecular diagnostics company that has developed innovative technologies to transform patient care. Its novel XNA technology provides ultra-sensitivity for ColoScape™ Colorectal Cancer Test. Powered by SuperbDNA™ technology, the company has developed revolutionary RadTox™ test that personalizes radiation therapy to mitigate adverse events. Based in Richmond, California, the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services.
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According to the recent FDA SARS-CoV-2 Reference Panel Comparative Data released on September 15, among all the FDA EUA tests with returned results, DiaCarta’s QuantiVirusTM SARS-CoV-2 Test and QuantiVirus™ SARS-CoV-2 Multiplex Test both rank within the top 3 for product sensitivity.
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