Five-minute point-of-care testing for SARS-CoV-2: Not there yet

Hogan, Catherine A.; Sahoo, Malaya K.; Huang, Chun; Garamani, Natasha; Stevens, Bryan; Zehnder, James L.; Pinsky, Benjamin A.

doi:10.1016/j.jcv.2020.104410

Cited by 33 publications

(45 citation statements)

References 2 publications

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“…Recent data support the test performance of the Cepheid Xpert SARS-CoV-2 assay, with agreement of over 99% compared to high-complexity EUA assays ( 8 , 16 , 17 ). In contrast, some studies have raised concerns regarding the diagnostic accuracy of ID NOW, with positive percent agreement ranging from 75% to 94% compared to reference assays ( 8 – 10 , 18 ). Given the poor diagnostic performance of ID NOW and uncertainty regarding the availability of Xpert Xpress cartridges, the Accula system has been touted as an interesting POCT alternative, but data were previously lacking on its clinical performance.…”

Section: Discussionmentioning

confidence: 99%

“…The Accula SARS-CoV-2 test is a POCT that requires only 30 min from sample to answer and utilizes the existing palm-sized Accula dock system originally developed for rapid influenza and respiratory syncytial virus testing. Despite the multiple potential benefits of POC assays, concern has been raised regarding their lower sensitivity for COVID-19 diagnosis than standard high-complexity molecular-based tests ( 8 – 10 ). It remains unclear whether this decreased sensitivity is due to test validation studies being limited to in silico predictions and contrived samples using reference materials, as is the case currently for the Accula SARS-CoV-2 test.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens

et al. 2020

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Background: Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for diagnosis of SARS-CoV-2. The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. Objectives: The aim of this study was to assess test performance of the Accula SARS-CoV-2 test. Study design: The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT) targeting the envelope (E) gene. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa coefficient. Results: Overall percent agreement between the assays was 84.0% (95% confidence interval [CI] 75.3 to 90.6%), PPA was 68.0% (95% CI 53.3 to 80.5%) and the kappa coefficient was 0.68 (95% CI 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test, and showed low viral load burden with a median cycle threshold value of 37.7. NPA was 100% (95% CI 94.2 to 100%). Conclusion: Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings, and for confirmatory testing in individuals with moderate to high pre-test probability of SARS-CoV-2 who test negative on Accula.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens

et al. 2020

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“…Three studies did not identify any studied platform as the "comparator" or "reference standard," and instead only reported general, nondirectional measures of agreement such as overall agreement, Cohen's Kappa, or alternatively, the calculations of PPA and NPA were identical no matter their method of calculation (Supplementary Table 1). 39 , 53 , 54 Regarding quality evaluation ( Supplementary Table 3), the samples used for calculating test performance characteristics were reported to be selected for enrichment of positive samples, 34 , 39 for diversity of viral load, 52 , 54 otherwise curated, 50 or the method of selecting samples was unreported. 49 , 51 , 53 , 55 Symptomatic status of the patients was largely unreported.…”

Section: The Agreement Of Naat Platforms Compared To Other Naat Platfmentioning

confidence: 99%

The estimation of diagnostic accuracy of tests for COVID-19: A scoping review

Axell-House

Lavingia

Rafferty

et al. 2020

Journal of Infection

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Objectives: To assess the methodologies used in the estimation of diagnostic accuracy of SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) and other nucleic acid amplification tests (NAATs) and to evaluate the quality and reliability of the studies employing those methods. Methods: We conducted a systematic search of English-language articles published December 31, 2019-June 19, 2020. Studies of any design that performed tests on ≥10 patients and reported or inferred correlative statistics were included. Studies were evaluated using elements of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) guidelines. Results: We conducted a narrative and tabular synthesis of studies organized by their reference standard strategy or comparative agreement method, resulting in six categorizations. Critical study details were frequently unreported, including the mechanism for patient/sample selection and researcher blinding to results, which lead to concern for bias. Conclusions: Current studies estimating test performance characteristics have imperfect study design and statistical methods for the estimation of test performance characteristics of SARS-CoV-2 tests. The included studies employ heterogeneous methods and overall have an increased risk of bias. Employing standardized guidelines for study designs and statistical methods will improve the process for developing and validating rRT-PCR and NAAT for the diagnosis of COVID-19.

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“…Several molecular tools allowing a diagnosis in less than an hour have been evaluated. Of these, the fastest two (the Abbott ID NOW and the Mesa Accula) with less than 30 min of delay between sampling and answer accumulated evidence of poorer diagnostic performance with a lack of sensitivity [ 5 , 6 ]. Only the Cepheid Xpert Xpress SARS-CoV-2 assay has shown to be a valuable tool with a run-time of 45−50 min with hands on time limited to 2−3 min [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19

Fournier

Zandotti

Ninove

et al. 2020

Journal of Clinical Virology

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Background With the persistent COVID-19 pandemic, there is an urgent need to use rapid and reliable diagnostic tools for highly urgent cases. Antigen tests are disappointing with their lack of sensitivity. Among molecular tools allowing a diagnosis in less than an hour, only one, the Cepheid Xpert Xpress SARS-CoV-2 assay, has exhibited a good sensitivity. However, we are also facing a global shortage of reagents and kits. Thus, it is imperative to evaluate other point-of-care molecular tests. Methods We evaluated the VitaPCR™ RT-PCR assay, whose sample analysis time is of approximately 20 min, in nasopharyngeal secretions from 534 patients presenting to our Institute, for the diagnosis of COVID-19, and compared it to our routine RT-PCR assay. We also compared the two assays with tenfold dilutions of a SARS-CoV-2 strain. Results Compared to our routine RT-PCR and the previous diagnosis of COVID-19, the sensitivity, specificity, positive and negative predictive values of VitaPCR™ can be evaluated to be 99.3 % (155/156), 94.7 % (358/378), 88.6 % (155/175) and 99.7 % (358/359), respectively. Tenfold dilutions of a SARS-CoV-2 strain show that the VitaPCR™ was more sensitive that our routine RT-PCR assay. Conclusion The VitaPCR™ SARS-CoV-2 is an accurate rapid test, suitable for clinical practice that can be performed as part of a point-of-care testing, for the rapid diagnosis of COVID-19.

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Five-minute point-of-care testing for SARS-CoV-2: Not there yet

Cited by 33 publications

References 2 publications

Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens

Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens

The estimation of diagnostic accuracy of tests for COVID-19: A scoping review

Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19

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