WHO SARS-CoV-2 Test Kit Comparative Study

WHO Evaluation Report Downloads

WHO Evaluation Report IFU

In December, 2020 WHO issued an expression of interest to manufacturers of antibody detection assays to participate in a large comparative assessment being conducted at the NRL, a WHO Collaborating Centre and authorised WHO IVD Prequalification Evaluation Laboratory, and in cooperation with other partners including FIND, Erasmus Medical Centre, Duke NUS Singapore and the International Vaccines Institute.

The evaluation protocol was designed to assess the performance characteristics of the In-vitro diagnostics devices (IVDs) using a large and diverse set of carefully selected samples (WHO).

The table below presents a summary of all of the evaluation results, test kit information and study reports.

 

For further information, please email info@nrlquality.org.au and WHElab@who.int

 

Independent NRL contracted SARS-CoV-2 IVD assessments

In addition to the study above, under contract with Peter Doherty Institute, NRL assessed the performance of 12 rapid diagnostic tests listed in the Australian Registry of Therapeutic Goods by the Therapeutic Goods Administration.

NRL also provided fee for service agreements with manufacturers for similar assessments of SARS-CoV-2 serology test kits using an established protocol

A summary of the independent NRL contracted SARS-CoV-2 IVD assessments can be viewed here