October 8, 2020

expert reaction to study investigating a rapid point-of-care SARS-CoV-2 virus test, QIA-stat-Dx POCT, in a hospital

A study, published in the Lancet Respiratory Medicine, looked at a rapid point-of-care SARS-CoV-2 virus test, QIA-stat-Dx POCT, in a hospital.

Dr Rob Shorten, Chair of the Microbiology Committee at the Association of Clinical Biochemistry & Laboratory Medicine, said:

“This study demonstrates that this test is capable of delivering rapid, accurate results for SARS CoV-2.  Performing such tests near the patient (often termed point of care tests, or POCT) can offer great benefit in delivering a rapid diagnosis.  These can greatly aid medical teams to direct patients to the most appropriate care and allow segregation of patients that can prevent cross-infection.  Such tests are regularly used in hospitals for influenza each winter.

“This is an example of such a test that can detect and differentiate multiple infections in one go.  These tests are therefore useful when similar infections have similar symptoms.

“These tests typically test small numbers of samples, so are not useful for large-scale use.  They can however, as this study suggests, be used to rapidly diagnose an infection in an individual patient and therefore appropriately direct their subsequent care.

“The authors acknowledge that this is a real-world study with no randomisation of patients.  There could therefore be bias in the patients selected to undergo the test.  The results are very positive but the authors acknowledge that further randomised studies are need to fully evaluate the clinical usefulness of this test.”

Prof Graham Cooke, Professor of Infectious Diseases, Imperial College London, said:

“Studies of the impact of rapid testing in clinical practice are relatively uncommon.  This work from the Southampton group is particularly welcome in defining more clearly the value of rapid testing at a time when there was a high prevalence of SARS-CoV2 in hospital admissions.  Although randomisation was not possible, the investigators report clear benefits for prompt placement of patients in appropriate wards and entering clinical trials.  We can assume that now we have specific treatments available, rapid testing might also help clinicians start treatments earlier.  As we look to scale up both clinical and non-clinical testing, we’re going to need more studies like this to help us understand the role of new tests in a variety of settings.”

Prof Ravindra Gupta, Professor of Clinical Microbiology, University of Cambridge, said:

“Rapid diagnostics with nucleic acid based testing is critical for hospital functioning during the second wave.  These are welcome data from a well conducted study in hospital during the first wave.  However, the claim that it is the first to assess real world assessment of point of care is inaccurate; the SAMBA point of care testing study was published on July 15 in Cell Reports Medicine, and similarly showed faster turn around time, increased availability of isolation rooms and improved hospital functioning.  SAMBA has been implemented in numerous hospital trusts nationwide.  We however will need a combination of platforms in order to meet national demand and QIA-stat-Dx will no doubt play an important role in protecting our hospitals.”

Prof Lawrence Young, Professor of Molecular Oncology, Warwick Medical School, said:

“This is an exciting development which highlights the value of rapid near-patient testing for detecting SARS-CoV-2 infection.

“The study demonstrates that a point-of-care test (QIstat-Dx Respiratory SARS-CoV-2 Panel) is just as good as the standard PCR test used in centralised laboratories and that it can return results with a median time of 1.7 hours as compared with 21.3 hours for the standard test.  The value of this approach in rapidly identifying infected patients means that such individuals can be quickly isolated away from non-infected patients leading to improved infection control.  It also means that infected patients can be more rapidly and efficiently enrolled in clinical trials.

“There has been much discussion about the value of rapid point-of-care testing to quickly identify and isolate infected individuals in high risk settings such as hospitals and care homes.  This study confirms the value of such an approach but there are a number of limitations including the lack of randomisation of the study groups and comparisons being compromised by the fact that the point-of-care group had more severe disease.

“Nevertheless, this study heralds the advent of point-of-care testing and highlights the potential impact of this approach in managing infection in hospitals and potentially other settings (e.g. care homes, airports etc.).  Future studies with different point-of-care platforms need to be carefully performed with appropriate randomisation and control groups alongside robust comparisons with standard PCR tests.”

‘Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study’ by Nathan J Brendish et al. was published in the Lancet Respiratory Medicine at 23:30 UK time on Thursday 8 October 2020.

DOI: 10.1016/S2213-2600(20)30454-9

Declared interests

Prof Graham Cooke: “Graham Cooke is an investigator on studies evaluating rapid diagnostics, including COVIDnudge and REACT programmes,  and infection lead for the London in-vitro diagnostics co-operative.”

Prof Ravindra Gupta: “None.”

Prof Lawrence Young: “I am a scientific advisor to Abingdon Health for their COVID-19 rapid antibody test.”

None others received.