Performance of an alternative RT-PCR procedure using residual sample from the Panbio™ Ag COVID-19 test

• Autor(a) principal: Castineiras,Terezinha Marta Pereira Pinto
• Data de Publicação: 2021
• Outros Autores: Nascimento,Érica Ramos dos Santos, Faffe,Débora Souza, Galliez,Rafael Mello, Mariani,Diana, Leitão,Isabela de Carvalho, Melo,Mayla Gabryele Miranda de, Ferreira,Orlando Costa, Tanuri,Amilcar
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Brazilian Journal of Infectious Diseases
• Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1413-86702021000500204
• topic: COVID-19; Antigen rapid test; RT-PCR

ABSTRACT Introduction: In the current standard of care (SoC) RT-PCR method for COVID-19, the patient’s swab was extracted in viral transport media (VTM). For the PanbioTM COVID-19 Ag Rapid Test, the patient swab is flushed out in extraction buffer, of which a small fraction is used for testing, leaving more than half the sample unused. This study was designed to show that RT-PCR results from the residual sample of the PanbioTM COVID-19 Ag Rapid Test (called Novel RT-PCR) are not worse than the SoC RT-PCR result. Methods: The study was performed using (1) dilution series of five patient samples, and (2) 413 patient samples comparing SOC versus Novel RT-PCR results. Results: For the dilution series samples, all tested positive by both methods. The bias between Ct values of Novel RT-PCR and SoC RT-PCR did not exceed 3.00 Ct using primers N1 and N2. A total of 413 COVID symptomatic patients seeking COVID testing were tested, of which 89 patients tested positive and 324 tested negative with SoC RT-PCR. In 324 patients who tested negative with SoC RT-PCR, 323 tested negative with Novel RT-PCR, and one (1) tested positive. Out of 89 who tested positive with SoC RT-PCR, 80 tested positive with the Novel RT-PCR, and nine patients showed a negative test result. The Overall Percent Agreement for the 413 valid patient sample pairs was 97.5 [95% CI 97 to 98]. Conclusion: The study demonstrated that the performance of the Novel RT-PCR method is acceptable compared to the SoC RT-PCR method and can be a useful tool to perform RTPCR without the need for new swab collections.