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20th May 2020 Author: Paul Carton
WHO Release COVID-19 Test Scores of 100%
Several PCR-based COVID-19 tests have demonstrated a 100% accuracy in an independent study, facilitated through the World Health Organization (WHO) and the Foundation for Innovative Diagnostics (FIND) collective. The tests undergo clinical specificity and sensitivity evaluation and are performed as outlined in each kit's Instructions For Use (IFU) document.
The Seegene Allplex™ 2019-nCoV Assay, which was the only kit to have three assays; targeting the E, N and RdRP genes, scored 100% accuracy in each test.
The COVID-19 RT-PCR kits that have 100% accuracy according to the WHO-FIND study are as follows:
- Boditech's ExAmplar COVID-19
- Certest's VIASURE SARS-CoV-2
- KH Medical's RADI COVID-19 Detection Kit
- Primer Design's Z-Path-COVID-19
- R-Biopharm's RIDA®GENE SARS-CoV-2
The majority of kits scoring 100% were performed on the Bio-Rad CFX96 PCR device, and some on the Roche 480 LightCycler.
Also, the rapid 45-minute point-of-care iAMP COVID-19 test from Atila BioSystems scored 100% for its ORF1A assay and 99% for its N-gene assay.
FIND is curating a global diagnostic pipeline and tracking reported global diagnostic use, and will be performing these independent studies on antibody tests in due course. The studies are being conducted at the Hôpitaux Universitaires Genève, in Geneva Switzerland, where both WHO and FIND have their headquarters.
To be part of the study, FIND invited manufacturers around the world to participate and have their kits validated to create a centralized database of test performances 'as a global public good'.
These molecular test kit studies verify the limit of detection (LOD) and the clinical performance as reported by the manufacturers. The LOD analysis is performed by using cultured viral stocks from a clinical isolate from Switzerland and quantified using an E gene standard. The clinical performance analysis is conducted on extracted samples from individuals suspected to have COVID-19 that were tested using an in-house PCR protocol that was optimized based on the Tib Molbiol assay (WHO protocol).
Date Published: 20th May 2020
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