Rapid and point of care testing for SARS-CoV-2
Simon Collins, HIV i-Base
Testing for SARS-CoV-2 in most countries continues to be controversial with delayed and limited access to PCR tests.
In the UK, many NHS labs are now prioritising coronavirus over other routine services, for example, CD4 and viral load will be less frequent in HIV clinics and HIV and STI testing in PrEP services will be limited to people who are symptomatic.
The articles linked here include a review of diagnostic research and report two rapid tests recently approved by the US FDA.
Fast, portable tests come online to curb coronavirus pandemic
A review of different technologies used to diagnose CoV-2 and including development of rapid and point of care testing.
Ref: Sheridan C, Fast, portable tests come online to curb coronavirus pandemic. Nature Biotechnology (23 March 2020).
FDA approves 45-minute coronavirus test from Cepheid
First FDA approval of new rapid test for coronavirus that uses the GeneXpert technology and machines used to diagnose TB.
However, Cepheid are planning to charge double the cost for use in COVID-19 for the same cartridges used for TB (see comment below).
Ref: Cepheid PR. Xpert Xpress SARS-CoV-2 has received FDA Emergency Use Authorization. (21 March 2020.
FDA approves 15-minute coronavirus test from Abbott
FDA approval of point of care test manufactured by Abbott Laboratories that provides results within 15 minutes. The press release from Abbott includes that positive results can show within five minutes and negative results within eight minutes.
Ref: Abbott PR. Abbott launches molecular point-of-care test to detect novel coronavirus in as little as five minutes. (27 March 2020).
According to a press statement for Medecines Access Campaign, Cepheid will charge US$19.80 per test in developing countries, using machines that are used for TB, HIV and other diseases. In the world’s poorest countries, people live on less than two dollars per day.
MSF and others’ research on Cepheid’s TB test (which uses a similar test cartridge for TB for which the corporation charges $10 in developing countries), shows that the cost of goods, including manufacturing, overhead, and other expenses, for each cartridge is as low as $3, and therefore each test could be sold at a profit for $5.
Ref: MSF press statement. MSF calls for no patents or profiteering on COVID-19 drugs, tests, and vaccines in pandemic. (27 March 2020).