Multisite Clinical Validation of Isothermal Amplification-Based SARS-CoV-2 Detection Assays Using Different Sampling Strategies

Article Medical Laboratory Technology

Variation in LOD Across SARS-CoV-2 Assay Systems: Need for Standardization

Youvraj Sohni

Summary: Multiple SARS-CoV-2 EUA tests are being used for clinical testing across various laboratories to address the diagnostic challenges of the pandemic, but variations in performance characteristics need to be recognized. Understanding the clinical implications of these variations, especially in LOD, is crucial. Standardizing measures, international standards, and reference materials may help alleviate clinical decision-making challenges caused by cross-assay variation in LOD among different diagnostic assays.

LABORATORY MEDICINE (2021)

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Article Medicine, General & Internal

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Julien Favresse et al.

Summary: This study compared the clinical performance of five antigen detection tests for SARS-CoV-2 infection, with the VITROS automated assay showing 100% sensitivity and specificity for Ct values <= 33, outperforming rapid antigen detection tests and aligning with RT-PCR.

JOURNAL OF CLINICAL MEDICINE (2021)

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Letter Infectious Diseases

Concerns regarding the sensitivity of the OptiGene direct SARS-CoV-2 LAMP assay and its suitability for use in at-risk groups and hospital staff

Eleri S. W. Wilson-Davies et al.

JOURNAL OF INFECTION (2021)

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Letter Infectious Diseases

Critical evaluation of the methodology used by Wilson-Davies et al., (2020) entitled Concerning the Optigene Direct LAMP assay, and it's use in at-risk groups and hospital staff

Veronica Fowler et al.

JOURNAL OF INFECTION (2021)

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Editorial Material Medicine, General & Internal

Put to the test: use of rapid testing technologies for covid-19

Alex Crozier et al.

BMJ-BRITISH MEDICAL JOURNAL (2021)

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Editorial Material Medicine, General & Internal

In suspected SARS-CoV-2, rapid antigen detection tests had 67% to 73% sensitivity and 98% to 100% specificity

Steven D. Stovitz

ANNALS OF INTERNAL MEDICINE (2021)

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Review Medicine, General & Internal

Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection

Jacqueline Dinnes et al.

Summary: Accurate and rapid diagnostic tests for SARS-CoV-2 infection are crucial for managing the COVID-19 pandemic. Point-of-care antigen and molecular tests can increase access to testing and expedite clinical and public health management decisions. Studies show that antigen tests have varying sensitivity, with higher accuracy in the first week of infection, and the efficacy of molecular tests depends on the specific brand used.

COCHRANE DATABASE OF SYSTEMATIC REVIEWS (2021)

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Editorial Material Microbiology