gold standard test for covid-19

Highly sensitive, Highly specific

Histopath uses Roche and ThermoFisher RT PCR platforms, both international market leaders in PCR testing. Both platforms have been validated for detection of SARS-CoV-2 RNA. Our practice has elected to use both platforms as the molecular targets vary slightly, having access to both provides the opportunity to cross check.

PCR testing amplifies minute quantities of viral RNA from samples collected using nasal / throat swabs. Because of the amplification process, the tests are extremely sensitive, detecting just a few viral particles. The published level of detection from replicate tests is 3.9 copies per reaction, which is close to the 95% hit rate of 2.9 copies per reaction, according to the Poisson distribution, expected when one RNA molecule is detected.

PCR molecular testing is currently regarded as the most reliable way to diagnose COVID-19. Other tests such as IgG/IgM rapid tests using finger prick blood are not suitable for diagnosing active infection and even when positive, cannot definitively confirm immunity to SARS-CoV-2

How PCR Works

Self Collect swabs for PCR test

PCR testing for SARS-CoV-2 requires collection of virus particles and infected cells from the nose or throat. As the test is highly sensitive, only a few particles are required. Numerous references can be found in the literature indicating that viral detection rates using patient self collected swabs from the nose / throat and swabs performed by healthcare providers are comparable. The approach has been used extensively in the United Kingdom and more recently by the Melinda and Bill Gates Foundation in the United States for influenza and Covid-19 testing. Provided adequate instruction is provided, reports indicate that the practice is reliable, safe and convenient for the patient. Some reports suggest that the approach is less traumatic for the patient.

Histopath provides self collection kits for patients for Covid-19 testing. Self collection means that patients can remain in isolation and do not need to attend clinics, avoiding contact with healthcare professionals and limiting potential transmission of the virus.

FDA approves self collection