A Novel Medical Technology for Rapid Molecular Diagnostics (Nicking Enzyme Amplification Reaction [NEAR]) - A Systematic Literature Review, Meta-Analysis

Speaker(s)

Grys M1, Pieniazek I1, Walczak J1, Debray R2, Cybulski J3, Przygodzki P4
1Arcana Institute, a Certara company, Cracow, MA, Poland, 2Abbott Rapid Diagnostics Ltd, Maidenhead, UK, 3Abbott Medical Sp. z o.o., Warsaw, Poland, 4Abbott Medical Sp. z o.o., Warszawa, Poland

Presentation Documents

OBJECTIVES: The RT-PCR method is often regarded as the "gold standard" method for the detection of SARS-COV-2. A limitation of PCR however, is the ‘time to result’. With a rapid molecular diagnostic test (intervention), results can be obtained much quicker (3-15 minutes). The objective was to to evaluate the diagnostic efficacy of one of the rapid molecular diagnostic tests for the qualitative detection of SARS-CoV-2 (COVID-19) infection, in comparison to RT-PCR.

METHODS: We systematically searched EMBASE, Medline and the Cochrane Library through November 31, 2021. All prospective studies on the diagnostic efficacy of the assessed intervention compared with RT-PCR in symptomatic patients were retrieved. Only studies conducted according to the valid protocol recommended by the manufacturer were included: dry swab collected by investigator; samples for intervention and control taken from the same anatomical place; "fresh" samples, tested shortly after collection without freezing.

RESULTS: The meta-analysis of the eligible studies (n=7; 3,493 patients) showed sensitivity of the intervention was 0.956 (95% CI: 0.918 - 0.976) and specificity was 0.995 (95% CI: 0.946-0.999) compared with the RT-PCR. In the subset of studies, which considered patients with no more than 7 days from the onset of symptoms, the sensitivity of the intervention was 0.987 (95% CI: 0.917 - 0.998) and the specificity was 0.989 (95% CI: 0.989 - 0.989) compared with the RT-PCR method.

CONCLUSIONS: There is significant unmet need for both a rapid and accurate diagnostic test to detect COVID-19. Thanks to the technology used to obtain an accurate result, clinicians can make evidence-based decisions in a short period of time. Compared to other published systematic reviews (SR), this SR showed that following the updated protocol for the intervention usage the diagnostic efficacy of the intervention increased substantially.

Code

MT31

Topic

Clinical Outcomes, Medical Technologies

Topic Subcategory

Comparative Effectiveness or Efficacy, Diagnostics & Imaging

Disease

SDC: Infectious Disease (non-vaccine), STA: Medical Devices