Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance

Degli-Angeli, Emily J; Dragavon, Joan; Huang, Meei Li; Lucic, Danijela; Cloherty, Gavin; Jerome, Keith R.; Greninger, Alexander L.; Coombs, Robert W.

doi:10.1016/j.jcv.2020.104474

Cited by 57 publications

(39 citation statements)

References 4 publications

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“… 33 , 34 , 35 Two studies evaluated Abbott RealTime with rSN or rPPA of 93% to 100%, and rSP or rNPA of 92.4% to 100%. 34 , 36 Three studies evaluated Cepheid Xpert Xpress, with rPPA 96.1% to 100%, rNPA 74.3% to 100%, rOA 96.1% to 100%, and Cohen's Kappa of 0.92. 37 , 38 , 39 Two studies evaluated Diasorin Simplexa with rSN or rPPA of 96% to 100%, and rSN of 100%.…”

Section: Resultsmentioning

confidence: 99%

“…With regards to quality evaluation (Supplementary Table 3), most studies did not report method of sample collection/patient recruitment, 33 , 35 , 37 , 41 , 42 , 43 , 44 , 45 , 46 , 47 and four studies conducted a convenience selection of samples, including enrichment for positive samples. 34 , 35 , 36 , 39 Eight studies conducted test performance calculations on sample numbers instead of patient numbers. 33 , 35 , 36 , 38 , 39 , 42 , 43 , 44 Four studies conducted calculation of test performance characteristics with indeterminate or inconclusive results as “positive,” 35 , 38 , 39 , 42 and the management of indeterminate/inconclusive as well as invalid results went unreported in an additional three studies.…”

Section: Resultsmentioning

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: Resultsmentioning

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

View full text Add to dashboard Cite

show abstract

“…According to the package insert, the clinical performance evaluation study showed both 100% positive (95% CI 94, 100) and negative (95% CI 88.8, 100) percent agreement. In a subsequent study, the sensibility and specificity of this assay were found to be 93% and 100%, respectively [12].…”

Section: Sars-cov-2 Testingmentioning

confidence: 86%

Clinical Profiles in Renal Patients with COVID-19

Arenas

Crespo

Pérez‐Sáez

et al. 2020

JCM

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The COVID-19 pandemic has led to frequent referrals to the emergency department on suspicion of this infection in maintenance hemodialysis (MHD) and kidney transplant (KT) patients. We aimed to describe their clinical features comparing confirmed and suspected non-confirmed COVID-19 cases during the Spanish epidemic peak. Confirmed COVID-19 ((+)COVID-19) corresponds to patient with positive RT-PCR SARS-CoV-2 assay. Non-confirmed COVID-19 ((−)COVID-19) corresponds to patients with negative RT-PCR. COVID-19 was suspected in 61 patients (40/803 KT (4.9%), 21/220 MHD (9.5%)). Prevalence of (+)COVID-19 was 3.2% in KT and 3.6% in MHD patients. Thirty-four (26 KT and 8 MHD) were (+)COVID-19 and 27 (14 KT and 13 MHD) (−)COVID-19. In comparison with (−)COVID-19 patients, (+)COVID-19 showed higher frequency of typical viral symptoms (cough, dyspnea, asthenia and myalgias), pneumonia (88.2% vs. 14.3%) and LDH and CRP while lower phosphate levels, need of hospital admission (100% vs. 63%), use of non-invasive mechanical ventilation (36% vs. 11%) and mortality (38% vs. 0%) (p < 0.001). Time from symptoms onset to admission was longer in patients who finally died than in survivors (8.5 vs. 3.8, p = 0.007). In KT and MHD patients, (+)COVID-19 shows more clinical severity than suspected non-confirmed cases. Prompt RT-PCR is mandatory to confirm COVID-19 diagnosis.

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“…In Morocco, the rapid test trademark used showed in foreign studies a better sensitivity after 14 days from the onset of symptoms and raised some concerns about its usefulness for COVID-19 confirmation [8]. Controversially, the molecular test of the same trademark was reported as highly accurate in the USA [9]. More information about PoC assays accuracy for Detection SARS-CoV-2 become available, and none of the published studies considers the non-ELISA PoC ones as adapted for detection of suspected patients either symptomatic or asymptomatic, due to the high risk of false negatives especially during the beginning days from the onset [10][11][12][13][14][15][16].…”

Section: Point Of Care (Poc) Serology Tests and Vaccination As Prmentioning

confidence: 99%

COVID-19 case management: The policy model in Morocco context

Bennis¹

2020

Preprint

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BackgroundBased on the updated scientific evidence around SARS-CoV-2 diagnostic, health policymakers had to consider that many decisions could enhance or limit the success of the overall COVID-19 control strategy. The purpose of this study is to share alternative COVID-19 case management based on the updated international knowledge.MethodsThis study presents the main information about COVID-19 case management in Morocco from March to October 2020. The NVivo qualitative model content analysis was used to compare and prioritize health decisions with updated scientific evidence.ResultsThe lack of molecular diagnostic accuracy using the interpretation of cycles quantification values, was targeted only by allowing all private laboratories to do RT qPCR. However, there is an urgent need for standardisation with accurate molecular SARS-CoV-2 thermocyclers and kits that notify systematic cycles quantification and do more tests per days to control the spread effectively. A predictive tree of the cycle’s range is presented following three steps: 1) the initial clinical definition, 2) the molecular confirmation, 3) and the diagnostic follows up results of the RT qPCR up to 28 days after the onset. At the same time, the seasonal vaccination against influenza and pneumonia could help to reduce COVID-19 deaths.ConclusionsUntil an available SARS-CoV-2 specific vaccine and/or curative effective treatment, updated control strategy in Morocco and similar context countries require to target population living in highly COVID-19 epidemic cities or areas by mass testing with the right interpretation of PCR values changes, associated to seasonal vaccination to foster the immunity.

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Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance

Cited by 57 publications

References 4 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

Clinical Profiles in Renal Patients with COVID-19

COVID-19 case management: The policy model in Morocco context

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