Laboratory Medicine and Quality Assurance

Table. 2.

Clinical performance evaluation of the INCLIX TRF COVID-19 & Flu A/B Ag test using rRT-PCR results (unit: %)

Performance SARS-CoV-2 Influenza A Influenza B
Sensitivity (95% CI) 90.91 (83.07–95.32) 97.75 (92.17–99.38) 93.00 (86.25–96.57)
Specificity (95% CI) 100.00 (98.86–100.00) 100.00 (98.81–100.00) 100.00 (98.81–100.00)
PPV (95% CI) 100.00 (95.42–100.00) 100.00 (95.77–100.00) 100.00 (96.03–100.00)
NPV (95% CI) 97.56 (95.40–98.73) 99.38 (97.76–99.83) 97.78 (95.58–98.90)

Abbreviations: COVID-19, coronavirus disease 2019; rRT-PCR, real-time reverse transcription-polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; CI, confidence interval; PPV, positive predictive value; NPV, negative predictive value.

Lab Med Qual Assur 2024;46:208~213 https://doi.org/10.15263/jlmqa.2024.46.4.208
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