Preanalytical issues affecting the diagnosis of COVID-19

Payne, Daniel; Newton, Darren J.; Evans, Paul C.; Osman, Husam; Baretto, Richard

doi:10.1136/jclinpath-2020-206751

Cited by 24 publications

(28 citation statements)

References 10 publications

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“…Of particular note, pre-analytical issues can negatively impact the diagnostic accuracy and affect less sensitive tests more severely [16]. To name a few of these potentially relevant pre-analytical factors: the timing of the swab relative to the onset of symptoms, the swabbing practices and test procedures, in particular when POCT is not performed by trained health care professionals.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting

Osterman

Baldauf²,

Eletreby³

et al. 2021

Med Microbiol Immunol

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Successful containment strategies for the SARS-CoV-2 pandemic will depend on reliable diagnostic assays. Point-of-care antigen tests (POCT) may provide an alternative to time-consuming PCR tests to rapidly screen for acute infections on site. Here, we evaluated two SARS-CoV-2 antigen tests: the STANDARD™ F COVID-19 Ag FIA (FIA) and the SARS-CoV-2 Rapid Antigen Test (RAT). For diagnostic assessment, we used a large set of PCR-positive and PCR-negative respiratory swabs from asymptomatic and symptomatic patients and health care workers in the setting of two University Hospitals in Munich, Germany, i.e. emergency rooms, patient care units or employee test centers. For FIA, overall clinical sensitivity and specificity were 45.4% (n = 381) and 97.8% (n = 360), respectively, and for RAT, 50.3% (n = 445) and 97.7% (n = 386), respectively. For primary diagnosis of asymptomatic and symptomatic individuals, diagnostic sensitivities were 60.9% (FIA) (n = 189) and 64.5% (RAT) (n = 256). This questions these tests’ utility for the reliable detection of acute SARS-CoV-2-infected individuals, in particular in high-risk settings. We support the proposal that convincing high-quality outcome data on the impact of false-negative and false-positive antigen test results need to be obtained in a POCT setting. Moreover, the efficacy of alternative testing strategies to complement PCR assays must be evaluated by independent laboratories, prior to widespread implementation in national and international test strategies.

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Section: Discussionmentioning

confidence: 99%

Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting

Osterman

Baldauf²,

Eletreby³

et al. 2021

Med Microbiol Immunol

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“…23 However, the false-negative rate has important ramifications for gaining accurate clinical and epidemiological data, and false-negative results may lead to misdiagnoses in both patients and HCP, with increased risk of infection transmission. 24 So, combining routine laboratory test that can detect both acute phase proteins and specific altered leucocyte profile corresponding to COVID-19 infection could add parameters to more efficient control of suspected individuals. Nonetheless, the rapid development of point-of-care molecular or antigen tests are already a reality.…”

Section: Original Researchmentioning

confidence: 99%

Clinical and laboratory characteristics in outpatient diagnosis of COVID-19 in healthcare professionals in Rio de Janeiro, Brazil

et al. 2021

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AimsThis study aimed to identify the symptoms associated with early stage SARS-CoV-2 (COVID-19) infections in healthcare professionals (HCPs) using both clinical and laboratory data.MethodsA total of 1297 patients, admitted between 18 March and 8 April 2020, were stratified according to their risk of developing COVID-19 using their responses to a questionnaire designed to evaluate symptoms and risk conditions.ResultsAnosmia/hyposmia (p<0.0001), fever (p<0.0001), body pain (p<0.0001) and chills (p=0.001) were all independent predictors for COVID-19, with a 72% estimated probability for detecting COVID-19 in nasopharyngeal swab samples. Leucopenia, relative monocytosis, decreased eosinophil values, C reactive protein (CRP) and platelets were also shown to be significant independent predictors for COVID-19.ConclusionsThe significant clinical features for COVID-19 were identified as anosmia, fever, chills and body pain. Elevated CRP, leucocytes under 5400×109/L and relative monocytosis (>9%) were common among patients with a confirmed COVID-19 diagnosis. These variables may help, in the absence of reverse transcriptase PCR tests, to identify possible COVID-19 infections during pandemic outbreaks.SummaryFrom 19 March to 8 April 2020, 1297 patients attended the Polyclinic Piquet Carneiro for COVID-19 detection. HCP data were analysed, and significant clinical features were anosmia, fever, chills and body pain. Elevated CRP, leucopenia and monocytosis were common in COVID-19.

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“…(2) common pre-analytical issues (e.g., inadequate specimen collection), which may lead to insufficient quantities of virus genetic material and ultimately false negative results. 83 While the quantities of genetic material obtained through swabbing may correlate with individual viral loads, they are confounded by ''random effects'' associated with the specimen collection process (type of swab used and accessibility of sampling site). Our modeling demonstrates that these random effects or ''noise'' are considerable (Fig.…”

Section: Discussionmentioning

confidence: 99%

An intra-host SARS-CoV-2 dynamics model to assess testing and quarantine strategies for incoming travelers, contact management, and de-isolation

Toorn

Bourquain

et al. 2021

Patterns

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Non-pharmaceutical interventions (NPIs) remain decisive tools to contain SARS-CoV-2. Strategies that combine NPIs with testing may improve efficacy and shorten quarantine durations. We develop a stochastic within-host model of SARS-CoV-2 that captures temporal changes in test sensitivities, incubation- and infectious periods. We use the model to simulate relative transmission risk for (i) isolation of symptomatic individuals, (ii) contact person management and (iii) quarantine of incoming travelers. We estimated that testing travelers at entry reduces transmission risks to 21.3% ([20.7, 23.9], PCR) and 27.9% ([27.1, 31.1], rapid diagnostic tests; RDT), compared to unrestricted entry. We calculated that 4 (PCR) vs. 5 (RDT) days pre-test quarantine are non-inferior to a 10 days quarantine for incoming travelers and that 8 (PCR) vs. 10 (RDT) days of pre-test quarantine are non-inferior to 14 days post-exposure quarantine. De-isolation of infected individuals 13 days after symptom onset may reduce the transmission risk to <0.2% [<0.01, 6.0].

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Preanalytical issues affecting the diagnosis of COVID-19

Cited by 24 publications

References 10 publications

Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting

Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting

Clinical and laboratory characteristics in outpatient diagnosis of COVID-19 in healthcare professionals in Rio de Janeiro, Brazil

An intra-host SARS-CoV-2 dynamics model to assess testing and quarantine strategies for incoming travelers, contact management, and de-isolation

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