Comparison of a laboratory-developed test targeting the envelope gene with three nucleic acid amplification tests for detection of SARS-CoV-2

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

doi:10.1016/j.jcv.2020.104427

Cited by 40 publications

(35 citation statements)

References 5 publications

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Section: Resultsmentioning

confidence: 99%

“…19 Bulterys et al study evaluated an isothermal amplification method with rSN 82.8% and Cohen's kappa 0.86. 31 Wang, Cai, and Zhang et al evaluated one-step single-tube nested quantitative polymerase chain reaction (OSN-qRT-PCR) with Cohen's kappa of 0.737. 32 Regarding evaluation of quality (Supplementary Table 3), the majority of studies did not report how patient samples were selected for evaluation.…”

Section: The Performance Other Nucleic Acid Amplification Test Methodmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

Section: The Performance Other Nucleic Acid Amplification Test Methodmentioning

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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show abstract

“…Pool size was determined after literature review, accounting for an expected prevalence of <1% (6,7). Pools were created by combining 10 nasopharyngeal samples, and screening was performed by real-time reverse transcription PCR targeting the nucleocapsid gene (region N2) (8). We extracted demographic characteristics for a randomly selected subset of 100 persons.…”

mentioning

confidence: 99%

Retrospective Screening for SARS-CoV-2 RNA in California, USA, Late 2019

Hogan¹,

Garamani²,

Sahoo³

et al. 2020

Emerg. Infect. Dis.

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“…Atila iAMP assay showed a little decrease in sensitivity and needed the highest amount of nucleic acid (18 μL). This LAMP kit could provide faster results (1 h) than RT-PCR methods [ 78 ]. Loopamp kit based on the LAMP method was compared to the RT-PCR method for the detection SARS-CoV-2 in 76 nasopharyngeal swab samples.…”

Section: Current Detection Methods For Sars-cov-2mentioning

confidence: 99%

“…Atila iAMP showed a little decrease in sensitivity and needed the most amount of nucleic acid (18 μL). 1 h faster results than RT-PCR 80 [ 78 ] RT-LAMP CPA PSR N & Orf1ab 10 DNAcopiesμl −1 Simulated OP/NP LAMP had better LOD result for SARS-CoV-2 extracted RNA, Specific, Primer pairs designed for LAMP, CPA and PSR targeting N -sequence Excellent for a real diagnosis.LOD Lyophilized LAMP kit for Orf1ab 21.57 & N 43.14 copies/reaction 431.47 & 862.9 of CPA and PSR copies/reaction. [ 77 ] Hologic transcription TMA 5.5 × 10 2 copies in 1 out of 5 NP Sensitivity 98.1% (52/53) for TMA and 96.2% (51/53) for RT-PCR 116 [ 81 ] RT-RAA ORF1ab gene 2 copies/reaction NP/OP sputum, Nasal swab, BAL, Stool, Whole blood Sensitivity and specificity of RT-RAA was 97.63% (330/338) and 97.87% (596/609), Ultrafast speed of detection, 16 samples per run, A single person can finish 16 samples in 40 min by working with automatic DNA extraction.…”

Section: Novel Developed Technologies For Sars-cov-2 Detectionmentioning

confidence: 99%

Diagnostic techniques for COVID-19 and new developments

Sheikhzadeh

Eissa

Ismail

et al. 2020

Talanta

127

129

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COVID-19 pandemic is a serious global health issue today due to the rapid human to human transmission of SARS-CoV-2, a new type of coronavirus that causes fatal pneumonia. SARS -CoV-2 has a faster rate of transmission than other coronaviruses such as SARS and MERS and until now there are no approved specific drugs or vaccines for treatment. Thus, early diagnosis is crucial to prevent the extensive spread of the disease. The reverse transcription-polymerase chain reaction (RT-PCR) is the most routinely used method until now to detect SARS-CoV-2 infections. However, several other faster and accurate assays are being developed for the diagnosis of COVID-19 aiming to control the spread of infection through the identification of patients and immediate isolation. In this review, we will discuss the various detection methods of the SARS-CoV-2 virus including the recent developments in immunological assays, amplification techniques as well as biosensors.

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Comparison of a laboratory-developed test targeting the envelope gene with three nucleic acid amplification tests for detection of SARS-CoV-2

Cited by 40 publications

References 5 publications

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

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

Retrospective Screening for SARS-CoV-2 RNA in California, USA, Late 2019

Diagnostic techniques for COVID-19 and new developments

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