Based on evaluation of all the FDA-EUA approved kits before July 27, 2020, DiaCarta’s QuantiVirus™ 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 QuantiVirus 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.

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.

DiaCarta has validated these tests at its 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.