The ID NOW COVID-19, a high-speed high-performance assay

Area of Science:

• Clinical diagnostics
• Molecular biology
• Infectious disease research

Background:

• The ID NOW COVID-19 assay is a rapid diagnostic tool for identifying SARS-CoV-2 infections.
• Concerns regarding the performance of the ID NOW COVID-19 assay necessitate thorough evaluation.
• Accurate and timely diagnosis is crucial for managing the COVID-19 pandemic.

Purpose of the Study:

• To evaluate the diagnostic performance of the ID NOW COVID-19 assay.
• To compare the ID NOW COVID-19 assay against a reference RT-PCR method.
• To assess the reliability of the ID NOW COVID-19 assay for clinical use.

Main Methods:

• Evaluation of 48 fresh nasopharyngeal swabs using the ID NOW COVID-19 assay.
• Comparison of ID NOW results with a reference reverse transcription-polymerase chain reaction (RT-PCR) assay.
• Calculation of positive percent agreement, negative percent agreement, and Kappa value.

Main Results:

• The ID NOW COVID-19 assay demonstrated a positive percent agreement of 94.9% and a negative percent agreement of 100% compared to RT-PCR.
• Only two false negatives were identified, with high PCR cycle threshold values (37.5 and 39.2).
• A Kappa value of 0.88 indicated substantial agreement between the two methods.

Conclusions:

• The ID NOW COVID-19 assay is a highly accurate and rapid diagnostic tool for SARS-CoV-2 detection.
• The assay's performance, especially when using universal transport media (UTM), supports its clinical utility.
• The ID NOW COVID-19 assay allows for repeat testing and further genomic analyses from the same sample, enhancing its value.