Abstract
Background: Confirmatory testing of SARS-CoV-2 results is essential to reduce false positives, but comes at a cost of significant extra workload for laboratories and increased turnaround time. A balance must be sought. We analysed our confirmatory testing pathway to produce a more refined approach in preparation for rising case numbers. Methods: Over a 10-week low prevalence period we performed confirmatory testing on all newly positive results. Turnaround time was measured and results were analysed to identify a threshold that could be applied as a cut-off for future confirmatory testing and reduce overall workload for the laboratory. Results: Between 22/06/20 and 31/08/20 confirmatory testing was performed on 108 newly positive samples, identifying 32 false positive results (30 %). Turnaround time doubled, increasing by an extra 17 h. There was a highly statistically significant difference between initial Relative Light Unit (RLU) of results that confirmed compared to those that did not, 1176 vs 721 (P < 0.00001). RLU = 1000 was identified as a suitable threshold for confirmatory testing in our laboratory: with RLU ≥ 1000, 55/56 (98 %) confirmed as positive, whereas with RLU < 1000 only 12/38 (32 %) confirmed. Conclusions: False positive SARS-CoV-2 tests can be identified by confirmatory testing, yet this may significantly delay results. Establishing a threshold for confirmatory testing streamlines this process to focus only on samples where it is most required. We advise all laboratories to follow a similar process to identify thresholds that trigger confirmatory testing for their own assays, increasing accuracy while maintaining efficiency for when case numbers are high.
Original language | English |
---|---|
Article number | 104762 |
Number of pages | 3 |
Journal | Journal of Clinical Virology |
Volume | 136 |
DOIs | |
Publication status | Published - Mar 2021 |
Bibliographical note
Funding Information:We are very grateful to the staff of the Cambridge Clinical Microbiology and Public Health Laboratory including the laboratory managers, biomedical scientists, and all staff involved in SARS-CoV-2 testing for their dedicated work. This work was undertaken in a regional laboratory and should not be taken as a recommendation from PHE.
Publisher Copyright:
© 2021 Elsevier B.V.
Keywords
- COVID-19
- Confirmatory testing
- False positive
- Laboratory diagnosis
- SARS-CoV-2