Dataset Information

Clinical and Epidemiologic Evaluation of Inconclusive COVID-19 PCR Results Using a Quantitative Algorithm.

ABSTRACT:

Objectives

The inconclusive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) result causes confusion and delay for infection prevention precautions and patient management. We aimed to develop a quantitative algorithm to assess and interpret these inconclusive results.

Methods

We created a score-based algorithm by combining laboratory, clinical, and epidemiologic data to evaluate 69 cases with inconclusive coronavirus disease 2019 (COVID-19) PCR results from the Centers for Disease Control and Prevention (CDC) assay (18 cases) and the TaqPath assay (51 cases).

Results

We determined 5 (28%) of 18 (CDC assay) and 20 (39%) of 51 (TaqPath assay) cases to be false positive. Lowering the cycle threshold cutoff from 40 to 37 in the TaqPath assay resulted in a dramatic reduction of the false-positive rate to 14%. We also showed testing of asymptomatic individuals is associated with a significantly higher probability of having a false-positive result.

Conclusions

A substantial percentage of inconclusive SARS-CoV-2 PCR results can be false positive, especially among asymptomatic patients. The quantitative algorithm we created was shown to be effective and could provide a useful tool for clinicians and hospital epidemiologists to interpret inconclusive COVID-19 PCR results and provide clinical guidance when additional PCR or antibody test results are available.

SUBMITTER: Yang S

PROVIDER: S-EPMC7799210 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Clinical and Epidemiologic Evaluation of Inconclusive COVID-19 PCR Results Using a Quantitative Algorithm.

Yang Shangxin S Stanzione Nicholas N Uslan Daniel Z DZ Garner Omai B OB de St Maurice Annabelle A

American journal of clinical pathology 20210201 3

<h4>Objectives</h4>The inconclusive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) result causes confusion and delay for infection prevention precautions and patient management. We aimed to develop a quantitative algorithm to assess and interpret these inconclusive results.<h4>Methods</h4>We created a score-based algorithm by combining laboratory, clinical, and epidemiologic data to evaluate 69 cases with inconclusive coronavirus disease 2019 (COVID- ...[more]

PMID: 33274731

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Project description:BackgroundCoronavirus 2019 disease (COVID-19) is caused by the virus SARS-CoV-2, transmissible both person-to-person and from contaminated surfaces. Early COVID-19 detection among healthcare workers (HCWs) is crucial for protecting patients and the healthcare workforce. Because of limited testing capacity, symptom-based screening may prioritize testing and increase diagnostic accuracy.Methods and findingsWe performed a retrospective study of HCWs undergoing both COVID-19 telephonic symptom screening and nasopharyngeal SARS-CoV-2 assays during the period, March 9-April 15, 2020. HCWs with negative assays but progressive symptoms were re-tested for SARS-CoV-2. Among 592 HCWs tested, 83 (14%) had an initial positive SARS-CoV-2 assay. Fifty-nine of 61 HCWs (97%) who were asymptomatic or reported only sore throat/nasal congestion had negative SARS-CoV-2 assays (P = 0.006). HCWs reporting three or more symptoms had an increased multivariate-adjusted odds of having positive assays, 1.95 (95% CI: 1.10-3.64), which increased to 2.61 (95% CI: 1.50-4.45) for six or more symptoms. The multivariate-adjusted odds of a positive assay were also increased for HCWs reporting fever and a measured temperature ? 37.5°C (3.49 (95% CI: 1.95-6.21)), and those with myalgias (1.83 (95% CI: 1.04-3.23)). Anosmia/ageusia (i.e. loss of smell/loss of taste) was reported less frequently (16%) than other symptoms by HCWs with positive assays, but was associated with more than a seven-fold multivariate-adjusted odds of a positive test: OR = 7.21 (95% CI: 2.95-17.67). Of 509 HCWs with initial negative SARS-CoV-2 assays, nine had symptom progression and positive re-tests, yielding an estimated negative predictive value of 98.2% (95% CI: 96.8-99.0%) for the exclusion of clinically relevant COVID-19.ConclusionsSymptom and temperature reports are useful screening tools for predicting SARS-CoV-2 assay results in HCWs. Anosmia/ageusia, fever, and myalgia were the strongest independent predictors of positive assays. The absence of symptoms or symptoms limited to nasal congestion/sore throat were associated with negative assays.

Project description:Rationale, aims and objectivesCritics have charged that evidence-based medicine (EBM) overemphasises algorithmic rules over unstructured clinical experience and intuition, but the role of structured decision support systems in improving health outcomes remains uncertain. We aim to assess if delivery of anticoagulant prophylaxis in hospitalised patients with COVID-19 according to an algorithm based on evidence-based clinical practice guideline (CPG) improved clinical outcomes compared with administration of anticoagulant treatment given at individual practitioners' discretion.MethodsAn observational design consisting of the analysis of all acutely ill, consecutive patients (n = 1783) with confirmed COVID-19 diagnosis admitted between 10 March 2020 to 11 January 2022 to an US academic center. American Society of Haematology CPG for anticoagulant prophylaxis in hospitalised patients with COVID-19 was converted into a clinical pathway and translated into fast-and-frugal decision (FFT) tree ('algorithm'). We compared delivery of anticoagulant prophylaxis in hospitalised patients with COVID-19 according to the FFT algorithm with administration of anticoagulant treatment given at individual practitioners' discretion.ResultsIn an adjusted analysis, using combination of Lasso (least absolute shrinkage and selection operator) and propensity score based weighting [augmented inverse-probability weighting] statistical techniques controlling for cluster data, the algorithm did not reduce death, venous thromboembolism, or major bleeding, but helped avoid longer hospital stay [number of patients needed to be treated (NNT) = 40 (95% CI: 23-143), indicating that for every 40 patients (23-143) managed on FFT algorithm, one avoided staying in hospital longer than 10 days] and averted admission to intensive-care unit (ICU) [NNT = 19 (95% CI: 13-40)]. All model's selected covariates were well balanced. The results remained robust to sensitivity analyses used to test the stability of the findings.ConclusionsWhen delivered using a structured FFT algorithm, CPG shortened the hospital stay and help avoided admission to ICU, but it did not affect other relevant outcomes.

Dataset Information

Clinical and Epidemiologic Evaluation of Inconclusive COVID-19 PCR Results Using a Quantitative Algorithm.

Objectives

Methods

Results

Conclusions

Publications

Clinical and Epidemiologic Evaluation of Inconclusive COVID-19 PCR Results Using a Quantitative Algorithm.

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