Supply Chain Council of European Union |

Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study


 Study design

We did a single-centre, prospective, interventional, non-randomised trial, with a contemporaneous control group, in a secondary care facility in the UK. The study design was selected because a randomised trial was considered likely to be unacceptable to many patients in the context of a pandemic caused by an organism of unknown lethality at the time. The trial took place during the first wave of the pandemic in the UK, from March 20 to April 29, 2020. All patients were recruited from the acute medical unit, emergency department, or other acute areas of Southampton General Hospital, a large acute teaching hospital in Southampton, UK. The hospital serves a population of 650 000 for secondary care, and is run by the University Hospital Southampton NHS Foundation Trust, which sponsored the trial. The study was approved by the South Central—Hampshire A research ethics committee (reference 20/SC/0138) on March 16, 2020. The protocol is available online.

One protocol amendment (notified May 29, 2020; granted June 23, 2020) was made to change the control group from a pre-implementation control group to a contemporaneous control group. This change was made in recognition of the fact that most patients tested for COVID-19 before the start of the trial were ambulatory community patients who were tested in hospital as part of the containment phase of the pandemic, and were therefore not comparable to patients presenting with acute respiratory illness who were recruited into the intervention group of the trial.


For the intervention group, eligible participants were those who met the following criteria: age 18 years or older; capacity to give written informed consent (or, where capacity was lacking, consultee assent could be obtained); a provisional decision had been made by the assessing clinical team to admit the patient to hospital; located in either the acute medical unit, emergency department, or other acute areas; could be recruited within 24 h of presentation; and had an acute respiratory illness, or did not have acute respiratory illness but was suspected to have COVID-19 according to the current Public Health England (PHE) case definition. An episode of acute respiratory illness was defined as a provisional diagnosis of acute pulmonary illness—including pneumonia, bronchitis (non-pneumonic lower respiratory tract infection), and influenza-like illness—or an acute exacerbation of a chronic respiratory illness (including exacerbation of chronic obstructive pulmonary disease, asthma, or bronchiectasis). Patients were excluded if they declined nasal or pharyngeal swabbing, or had previously been included in the study and were presenting again within 14 days after the previous enrolment. The protocol originally allowed for recruitment of symptomatic members of hospital staff; however, this provision was abandoned after only a single staff member was enrolled.

The contemporaneous control group consisted of adults aged 18 years or older who presented with acute respiratory illness or suspected COVID-19 to the emergency department or acute medical unit during the study period (March 20 to April 29, 2020). These patients were eligible for inclusion in the intervention group but were not enrolled because of the capacity of the research team—we had insufficient research staff to recruit all patients with suspected COVID-19 during the day and did not have resources to deploy research teams overnight. Patients in this group were not asked to provide consent, and we collected routinely obtained, fully de-identified data (including demographic, clinical, and outcome data) retrospectively from hospital systems after local data protection assessment and approval.


Before recruitment began, a brief validation phase took place in which the QIAstat-Dx Respiratory SARS-CoV-2 Panel was evaluated using control material, under biosafety level 2 conditions within a class 2 medical safety cabinet, as per PHE guidance. The panel received CE marking on March 18, 2020.

QIAstat-Dx® Respiratory SARS-CoV-2 Panel instructions for use (Handbook).