Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2

Rapid detection of infection is essential for stopping the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Roche SD Biosensor rapid antigen test for SARS-CoV-2 was evaluated in a nonhospitalized symptomatic population. We rapid-tested a sample onsite and compared results with those from reverse transcription PCR and virus culture. We analyzed date of onset and symptoms using data from a clinical questionnaire.

Overall test sensitivity was 84.9% (95% CI 79.1–89.4) and specificity was 99.5% (95% CI 98.7–99.8). Sensitivity increased to 95.8% (95% CI 90.5–98.2) for persons who sought care within 7 days of symptom onset. Test band intensity and time to result correlated strongly with viral load; thus, strong positive results could be read before the recommended time. Approximately 98% of all viable specimens with cycle threshold <30 were detected. Rapid antigen tests can detect symptomatic sars-cov-2 rapid antigen test nasal instructions infections in the early phase of disease, thereby identifying the most infectious persons.

 

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged >1 year ago but still keeps a strong grip not only on daily life but also on diagnostic capacities.

  • Reverse transcription PCR (RT-PCR) has been the standard for diagnosis of acute infection  but has several limitations, such as the requirement for specialized laboratory infrastructure, trained personnel, and reagents that have been in shortage globally .
  • In addition, the current turnaround time from sample collection to reporting of the result may take >48 hours (J. van Beek et al., unpub. data,compromising effectiveness of triage, isolation, and contact tracing strategies. Rapid antigen detection tests (Ag RDT) for SARS-CoV-2 appeared on the market in early 2020, but initial reports of poor performance and the lack of independent evaluation results made governments reluctant to invest and consider inclusion into testing algorithms.
  • As of February 2021, more than 140 assays are on the market , but relatively few have been extensively validated  V.M. Corman et al., unpub. data.Initial results show that these tests are suitable for detecting early-onset cases with high viral load.
  • As expected, the sensitivity of the tests is lower than that of RT-PCR, but in patients in the early phase of illness who have high viral load, performance meets World Health Organization–set criteria of >80% sensitivity and >97% specificity compared with nucleic acid detection methods .
  • Thus, these tests could be useful in identifying the most infectious persons (J. van Beek et al.). In an outbreak scenario, diagnostics with lower sensitivity but a faster result can render interventions more effective than standard tests . Implementation of Ag RDT into testing algorithms would enable rapid detection and isolation of new cases and thereby support the test, trace, and isolate strategy with the intent to stop transmission chains and reduce the impact of coronavirus disease (COVID-19).
  • In this study, we assessed the performance of the Roche SD Biosensor SARS-CoV-2 rapid antigen test compared with both RT-PCR and virus culture.
  • We conducted the field evaluation study at a large public health service testing facility in Rotterdam-Rijnmond, the Netherlands, where most visitors sought care for COVID-19 symptoms.
  • Every person >18 years of age who had an appointment for SARS-CoV-2 RT-PCR testing was invited to participate. An additional nasopharyngeal swab specimen was obtained for the Ag RDT in parallel and processed onsite to compare sensitivity and specificity to RT-PCR.
  • All samples positive by Ag RDT and PCR were cultured to correlate results with infectivity. The medical research ethics committee of Utrecht decided the study was not subject to the Medical Research Involving Human Subjects Act and did not require full review by an accredited committee (protocol no. 20-606/C).

Testing Population, Setup and Patient Recruitment

The study was conducted at the largest drive-through testing location in Rotterdam-Rijnmond, at which testing is by appointment only. Eligibility for a free-of-charge test included either presence of symptoms or close contact with a confirmed SARS-CoV-2–infected person. Most persons who requested testing had symptoms. At the entrance of the testing site, we approached all persons >18 years of age; after providing written informed consent, they were enrolled in the study and directed to one of the dedicated testing posts for sampling.

Enrolled persons were also asked to fill in a clinical questionnaire stating the reason for appointment, date of onset or end date of symptoms, and a list of symptoms (fever, sore throat, coughing, shortness of breath/tightness, runny nose, diarrhea, eye complaints, nausea, rash, chills, headache, pain when breathing, coughing phlegm, muscle pain, painful/swollen lymph nodes, fatigue, vomiting, joint pain, loss of appetite, nosebleed, other). The study was conducted for 5 days to achieve the target of 800–1,000 participants. The SARS-CoV-2 rapid antigen test distributed by Roche SD Biosensor was provided by the Ministry of Health, Welfare, and Sport.

Testing Site Setup and the Mobile Laboratory

From the 6 available testing posts, we designated 2 posts for sample collection from study participant on the basis of 3 factors: maximum number of subjects per test post (≈150/day); known number of appointments per day; and expected enrollment rate based on initial results from other study sites in the Netherlands. We expected to include a maximum of 300 persons/day. The site’s regular trained personnel performed swabbing to avoid variations to the process. Testing was done on benchtop, in a mobile laboratory unit by trained staff dressed in full personal protective equipment (goggles, FFP3 mask, gloves, and disposable gown). Samples for the Ag RDT were collected at regular intervals and processed as soon as possible within 30 mins in convenient batches (5–10 tests at a time). Swab specimens and RDT devices were inactivated in chlorine and disposed of as biohazard material. Results were recorded in a Microsoft Access database designated for this study.

Specimen Collection, Testing and Culture Procedures

Standard method for SARS-CoV-2 testing was by RT-PCR, which was conducted in parallel with the Ag RDT on separate swab specimens. Two swab specimens (1 oropharyngeal and 1 nasopharyngeal swab) were taken for RT-PCR and virus culture, placed directly in 3 mL universal transport media and shipped to the Erasmus MC viroscience diagnostic laboratory (Rotterdam, the Netherlands). For the Ag RDT evaluation, a second nasopharyngeal swab specimen was taken from the same nostril, using the swab included in the kits, to directly compare RT-PCR results with Ag RDT results.

Swabs were placed into empty tubes to transport to the mobile laboratory onsite. Routine RT-PCR testing was performed on combined oropharyngeal and one nasopharyngeal swabs in virus transport medium using the cobas SARS-CoV-2 test on the COBAS6800 (Roche Diagnostics). Because cycle threshold (Ct) values differ between PCR methods, genome copies per milliliter were calculated based on an in-house established standard curve. The leftover virus transport medium from the oropharyngeal and nasopharyngeal swabs was directly inoculated onto Vero cells clone 118 without freezing or extended storage. Samples were cultured for 7 days; once cytopathic effect was visible, the presence of SARS-CoV-2 was confirmed with immunofluorescent detection of SARS CoV-2 nucleocapsid protein.

For the Ag RDT, the SD Biosensor SARS-CoV-2 rapid antigen test distributed by Roche (reference no. 9901-NCOV-01G; lot no. QCO3020079/Sub:A-2) was performed immediately onsite following manufacturer’s instructions. A 4-grade scaling readout (−; +/−, +; ++) representing the strength of the test band was used . Time until positive results was logged as <5 min, <10 min (not part of the manufacturer’s instructions for use), or 15 min; recommended readout was 15–30 min. When results were dubious (i.e., test line barely visible or labeled as +/− but regarded as positive test result), 2 persons performed the readout.

 

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Data Analysis

We merged data from the Ag RDT, RT-PCR, virus culture, and clinical questionnaire using Microsoft Access and data performed analysis using R version 4.0.2 . Sensitivity and specificity of Ag RDT were calculated in relation to the RT-PCR results. Wilcoxon score interval was used to determine CIs of proportions.