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Comparison of Two Commercial Platforms and a Laboratory-Developed Test for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA.

ABSTRACT: Mitigation of the ongoing coronavirus disease 2019 (COVID-19) pandemic requires reliable and accessible laboratory diagnostic services. In this study, the performance of one laboratory-developed test (LDT) and two commercial tests, cobas SARS-CoV-2 (Roche) and Amplidiag COVID-19 (Mobidiag), were evaluated for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory specimens. A total of 183 specimens collected from suspected COVID-19 patients were studied with all three methods to compare their performance. In relation to the reference standard, which was established as the result obtained by two of the three studied methods, the positive percent agreement was highest for the cobas test (100%), followed by the Amplidiag test and the LDT (98.9%). The negative percent agreement was lowest for the cobas test (89.4%), followed by the Amplidiag test (98.8%), and the highest value was obtained for the LDT (100%). The dilution series of positive specimens, however, suggests significantly higher sensitivity for the cobas assay in comparison with the other two assays, and the low negative percent agreement value may be due to the same reason. In general, all tested assays performed adequately. Clinical laboratories need to be prepared for uninterrupted high-throughput testing during the coming months to mitigate the pandemic. To ensure no interruption, it is critical that clinical laboratories maintain several simultaneous platforms in their SARS-CoV-2 nucleic acid testing.

SUBMITTER: Mannonen L

PROVIDER: S-EPMC7825913 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Serological assays for detection of IgG, IgM or IgA against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) play an important role in surveillance, antibody persistence, vaccine coverage and infection rate. Serological assays, including both ELISA and rapid lateral flow assays, are available commercially but the cost limits their accessibility for low resource countries. Although serological assays based on mammalian-expressed SARS-CoV-2 spike protein have been previously described these assays need to be validated using samples from local populations within the continent, or country, in which they will be used. Interpretation of results could be influenced by differences in specificity and potential for pre-existing cross-reactive antibodies. In this study, we investigated two laboratory developed serological assays, an enzyme linked immunosorbent assay (ELISA) and an immunofluorescent assay (IFA), developed using recombinant SARS-CoV-2 spike protein, for use in South African populations. The tests were compared with commercially available and South Africa Health Products Regulatory Authority (SAPHRA) approved assays. A panel of 100 residual diagnostic serum samples, collected prior to the pandemic, were tested on three separate occasions to determine a suitable cut-off value for differentiation of positive from negative samples. Specificity of 96 % and 100 % for ELISA and IFA respectively was demonstrated. A total of 82/89 serum samples collected between days 2-94 after onset of illness from patients with a positive molecular result were positive for IgG antibody. The sensitivity of the laboratory developed assays on samples collected > one week after onset of illness was shown to be 100 % and 98.8 % for ELISA and IFA respectively. Positive predictive values were 92.1 % for ELISA and 91.0 % for IFA using characterization of samples as positive based on confirmation of infection using RT-PCR. Serum samples (n = 62) collected from RT-PCR positive patients infected with either ancestral, or emerging variants such as Beta or Delta, tested positive for IgG antibody (62/62) using the laboratory developed assays confirming application of the assays regardless of currently circulating variant during the time of evaluation. High concordance was demonstrated between the laboratory developed assays and the commercial immunoassay among samples collected from South African populations, although the small sample size, especially for the comparison with commercial assays, must be noted. If all quality assurance controls are in place, the use of local laboratory developed assays for high-throughput screening in resource-constrained environments is a realistic alternative option.

Dataset Information

Comparison of Two Commercial Platforms and a Laboratory-Developed Test for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA.

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