The estimation of diagnostic accuracy of tests for COVID-19: A scoping review.
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ABSTRACT: 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.
SUBMITTER: Axell-House DB
PROVIDER: S-EPMC7457918 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.
| S-EPMC7327913 | biostudies-literature
Project description:ObjectiveTo collate the evidence on the accuracy parameters of all available diagnostic methods for detecting SARS-CoV-2.MethodsA systematic review with meta-analysis was performed. Searches were conducted in Pubmed and Scopus (April 2020). Studies reporting data on sensitivity or specificity of diagnostic tests for COVID-19 using any human biological sample were included.ResultsSixteen studies were evaluated. Meta-analysis showed that computed tomography has high sensitivity (91.9% [89.8%-93.7%]), but low specificity (25.1% [21.0%-29.5%]). The combination of IgM and IgG antibodies demonstrated promising results for both parameters (84.5% [82.2%-86.6%]; 91.6% [86.0%-95.4%], respectively). For RT-PCR tests, rectal stools/swab, urine, and plasma were less sensitive while sputum (97.2% [90.3%-99.7%]) presented higher sensitivity for detecting the virus.ConclusionsRT-PCR remains the gold standard for the diagnosis of COVID-19 in sputum samples. However, the combination of different diagnostic tests is highly recommended to achieve adequate sensitivity and specificity.
| S-EPMC7350782 | biostudies-literature
Project description:ObjectiveSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged as a global pandemic in early 2020 with rapidly evolving approaches to diagnosing the clinical illness called coronavirus disease (COVID-19). The primary objective of this scoping review is to synthesize current research of the diagnostic accuracy of history, physical examination, routine laboratory tests, real-time reverse transcription-polymerase chain reaction (rRT-PCR), immunology tests, and computed tomography (CT) for the emergency department (ED) diagnosis of COVID-19. Secondary objectives included a synopsis of diagnostic biases likely with current COVID-19 research as well as corresponding implications of false-negative and false-positive results for clinicians and investigators.MethodsA Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review (PRISMA-ScR)-adherent synthesis of COVID-19 diagnostic accuracy through May 5, 2020, was conducted. The search strategy was designed by a medical librarian and included studies indexed by PubMed and Embase since January 2020.ResultsA total of 1,907 citations were screened for relevance. Patients without COVID-19 are rarely reported, so specificity and likelihood ratios were generally unavailable. Fever is the most common finding, while hyposmia and hypogeusia appear useful to rule in COVID-19. Cough is not consistently present. Lymphopenia is the mostly commonly reported laboratory abnormality and occurs in over 50% of COVID-19 patients. rRT-PCR is currently considered the COVID-19 criterion standard for most diagnostic studies, but a single test sensitivity ranges from 60% to 78%. Multiple reasons for false-negatives rRT-PCR exist, including sample site tested and disease stage during which sample was obtained. CT may increase COVID-19 sensitivity in conjunction with rRT-PCR, but guidelines for imaging patients most likely to benefit are emerging. IgM and IgG serology levels are undetectable in the first week of COVID-19, but sensitivity (range = 82% to 100%) and specificity (range = 87% to 100%) are promising. Whether detectable COVID-19 antibodies correspond to immunity remains unanswered. Current studies do not adhere to accepted diagnostic accuracy reporting standards and likely report significantly biased results if the same tests were to be applied to general ED populations with suspected COVID-19.ConclusionsWith the exception of fever and disorders of smell/taste, history and physical examination findings are unhelpful to distinguish COVID-19 from other infectious conditions that mimic SARS-CoV-2 like influenza. Routine laboratory tests are also nondiagnostic, although lymphopenia is a common finding and other abnormalities may predict severe disease. Although rRT-PCR is the current criterion standard, more inclusive consensus-based criteria will likely emerge because of the high false-negative rate of PCR tests. The role of serology and CT in ED assessments remains undefined.
| S-EPMC7323136 | biostudies-literature
Project description:BackgroundCoronavirus disease (COVID-19) is a serious infectious disease that causes severe respiratory illness. This pandemic represents a serious public health risk. Therefore, early and accurate diagnosis is essential to control disease progression. Radiological examination plays a crucial role in the early identification and management of infected patients.ObjectiveThe aim of this review was to identify the diagnostic value of different imaging modalities used for diagnosis of COVID-19.MethodsA comprehensive literature search was conducted using the PubMed, Scopus, Web of Science, and Google Scholar databases. The keywords diagnostic imaging, radiology, respiratory infection, pneumonia, coronavirus infection and COVID-19 were used to identify radiology articles focusing on the diagnosis of COVID-19 and to determine the diagnostic value of various imaging modalities, including x-ray, computed tomography (CT), ultrasound, and nuclear medicine for identification and management of infected patients.ResultsWe identified 50 articles in the literature search. Studies that investigated the diagnostic roles and imaging features of patients with COVID-19, using either chest CT, lung ultrasound, chest x-ray, or positron emission topography/computed tomography (PET/CT) scan, were discussed. Of these imaging modalities, chest x-ray and CT scan are the most commonly used for diagnosis and management of COVID-19 patients, with chest CT scan being more accurate and sensitive in identifying COVID-19 at early stages. Only a few studies have investigated the roles of ultrasound and PET/CT scan in diagnosing COVID-19.ConclusionsChest CT scan remains the most sensitive imaging modality in initial diagnosis and management of suspected and confirmed patients with COVID-19. Other diagnostic imaging modalities could add value in evaluating disease progression and monitoring critically ill patients with COVID-19.
| S-EPMC7468642 | biostudies-literature
Project description:During the early phase of the coronavirus disease 2019 (COVID-19) pandemic, design, development, validation, verification and implementation of diagnostic tests were actively addressed by a large number of diagnostic test manufacturers. Hundreds of molecular tests and immunoassays were rapidly developed, albeit many still await clinical validation and formal approval. In this Review, we summarize the crucial role of diagnostic tests during the first global wave of COVID-19. We explore the technical and implementation problems encountered during this early phase in the pandemic, and try to define future directions for the progressive and better use of (syndromic) diagnostics during a possible resurgence of COVID-19 in future global waves or regional outbreaks. Continuous global improvement in diagnostic test preparedness is essential for more rapid detection of patients, possibly at the point of care, and for optimized prevention and treatment, in both industrialized countries and low-resource settings.
| S-EPMC7556561 | biostudies-literature
Project description:Estimates of disease prevalence in any host population are complicated by uncertainty in the outcome of diagnostic tests on individuals. In the absence of gold standard diagnostics (tests that give neither false positives nor false negatives), Bayesian latent class inference can be applied to batteries of diagnostic tests, providing posterior estimates of the sensitivity and specificity of each test, alongside posterior estimates of disease prevalence. Here we explore the influence of precision and accuracy of prior information on the precision and accuracy of posterior estimates of these key parameters. Our simulations use three diagnostic tests, yielding eight possible diagnostic outcomes per individual. Seven degrees of freedom allow the estimation of seven parameters: sensitivity and specificity of each test, and disease prevalence. We show that prior precision begets posterior precision but only when priors are accurate. We also show that analyses without gold standard can use imprecise priors as long as they are initialised with accuracy. Imprecise priors risk the divergence of MCMC chains towards inaccurate posterior estimates, if inaccurate initial values are used. We note that inaccurate priors can yield inaccurate and imprecise inference. Bounded priors should certainly not be used unless their accuracy is well established. Inaccurate estimates of sensitivity or specificity can yield wildly inaccurate estimates of disease prevalence. Our analyses are motivated by studies of bovine tuberculosis in a wild badger population.
| S-EPMC5958675 | biostudies-literature
Project description:Introduction: For the COVID-19 (SARS-CoV-2) response, COVID-19 antigen (Ag), and antibody (Ab) rapid diagnostic tests (RDTs) are expected to complement central molecular testing particularly in low-resource settings. The present review assesses requirements for implementation of COVID-19 RDTs in sub-Saharan Africa. Methods: Review of PubMed-published articles assessing COVID-19 RDTs complemented with Instructions for Use (IFU) of products. Results: In total 47 articles on two COVID-19 Ag RDTs and 54 COVID-19 Ab RDTs and IFUs of 20 COVID-19 Ab RDTs were retrieved. Only five COVID-19 Ab RDTs (9.3%) were assessed with capillary blood sampling at the point-of-care; none of the studies were conducted in sub-Saharan Africa. Sampling: Challenges for COVID-19 Ag RDTs include nasopharyngeal sampling (technique, biosafety) and sample stability; for COVID-19 Ab RDTs equivalence of whole blood vs. plasma/serum needs further validation (assessed for only eight (14.8%) products). Sensitivity-Specificity: sensitivity of COVID-19 Ag and Ab RDTs depend on viral load (antigen) and timeframe (antibody), respectively; COVID-19 Ab tests have lower sensitivity compared to laboratory test platforms and the kinetics of IgM and IgG are very similar. Reported specificity was high but has not yet been assessed against tropical pathogens. Kit configuration: For COVID-19 Ag RDTs, flocked swabs should be added to the kit; for COVID-19 Ab RDTs, finger prick sampling materials, transfer devices, and controls should be added (currently only supplied in 15, 5, and 1/20 products). Usability and Robustness: some COVID-19 Ab RDTs showed high proportions of faint lines (>40%) or invalid results (>20%). Shortcomings were reported for buffer vials (spills, air bubbles) and their instructions for use. Stability: storage temperature was ≤ 30°C for all but one RDT, in-use and result stability were maximal at 1 h and 30 min, respectively. Integration in the healthcare setting requires a target product profile, landscape overview of technologies, certified manufacturing capacity, a sustainable market, and a stringent but timely regulation. In-country deployment depends on integration in the national laboratory network. Discussion/Conclusion: Despite these limitations, successful implementation models in triage, contact tracing, and surveillance have been proposed, in particular for COVID-19 Ab RDTs. Valuable experience is available from implementation of other disease-specific RDTs in sub-Saharan Africa.
| S-EPMC7662157 | biostudies-literature
Project description:BackgroundA range of molecular amplification techniques have been developed for the diagnosis of Human African Trypanosomiasis (HAT); however, careful evaluation of these tests must precede implementation to ensure their high clinical accuracy. Here, we investigated the diagnostic accuracy of molecular amplification tests for HAT, the quality of articles and reasons for variation in accuracy.MethodologyData from studies assessing diagnostic molecular amplification tests were extracted and pooled to calculate accuracy. Articles were included if they reported sensitivity and specificity or data whereby values could be calculated. Study quality was assessed using QUADAS and selected studies were analysed using the bivariate random effects model.Results16 articles evaluating molecular amplification tests fulfilled the inclusion criteria: PCR (n?=?12), NASBA (n?=?2), LAMP (n?=?1) and a study comparing PCR and NASBA (n?=?1). Fourteen articles, including 19 different studies were included in the meta-analysis. Summary sensitivity for PCR on blood was 99.0% (95% CI 92.8 to 99.9) and the specificity was 97.7% (95% CI 93.0 to 99.3). Differences in study design and readout method did not significantly change estimates although use of satellite DNA as a target significantly lowers specificity. Sensitivity and specificity of PCR on CSF for staging varied from 87.6% to 100%, and 55.6% to 82.9% respectively.ConclusionHere, PCR seems to have sufficient accuracy to replace microscopy where facilities allow, although this conclusion is based on multiple reference standards and a patient population that was not always representative. Future studies should, therefore, include patients for which PCR may become the test of choice and consider well designed diagnostic accuracy studies to provide extra evidence on the value of PCR in practice. Another use of PCR for control of disease could be to screen samples collected from rural areas and test in reference laboratories, to spot epidemics quickly and direct resources appropriately.
| S-EPMC3254661 | biostudies-literature
Project description:BackgroundHaving a penicillin allergy label associates with a higher risk for antibiotic resistance and increased health care use.ObjectiveWe sought to assess the accuracy of skin tests and specific IgE quantification in the diagnostic evaluation of patients reporting a penicillin/β-lactam allergy.MethodsWe performed a systematic review and diagnostic accuracy meta-analysis, searching on MEDLINE, Scopus, and Web of Science. We included studies conducted in patients reporting a penicillin allergy and in whom skin tests and/or specific IgE quantification were performed and compared with drug challenge results. We quantitatively assessed the accuracy of diagnostic tests with bivariate random-effects meta-analyses. Meta-regression and subgroup analyses were performed to explore causes of heterogeneity. Studies' quality was evaluated using QUADAS-2 criteria.ResultsWe included 105 primary studies, assessing 31,761 participants. Twenty-seven studies were assessed by bivariate meta-analysis. Skin tests had a summary sensitivity of 30.7% (95% CI, 18.9%-45.9%) and a specificity of 96.8% (95% CI, 94.2%-98.3%), with a partial area under the summary receiver-operating characteristic curve of 0.686 (I2 = 38.2%). Similar results were observed for subanalyses restricted to patients reporting nonimmediate maculopapular exanthema or urticaria/angioedema. Specific IgE had a summary sensitivity of 19.3% (95% CI, 12.0%-29.4%) and a specificity of 97.4% (95% CI, 95.2%-98.6%), with a partial area under the summary receiver-operating characteristic curve of 0.420 (I2 = 8.5%). Projected predictive values mainly reflect the low frequency of true penicillin allergy.ConclusionsSkin tests and specific IgE quantification appear to have low sensitivity and high specificity. Because current evidence is insufficient for assessing the role of these tests in stratifying patients for delabeling, we identified key requirements needed for future studies.
| S-EPMC8019189 | biostudies-literature
Project description:The aim of this review is to determine whether automated computerised tests accurately identify patients with progressive cognitive impairment and, if so, to investigate their role in monitoring disease progression and/or response to treatment.Six electronic databases (Medline, Embase, Cochrane, Institute for Scientific Information, PsycINFO, and ProQuest) were searched from January 2005 to August 2015 to identify papers for inclusion. Studies assessing the diagnostic accuracy of automated computerised tests for mild cognitive impairment (MCI) and early dementia against a reference standard were included. Where possible, sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios were calculated. The Quality Assessment of Diagnostic Accuracy Studies tool was used to assess risk of bias.Sixteen studies assessing 11 diagnostic tools for MCI and early dementia were included. No studies were eligible for inclusion in the review of tools for monitoring progressive disease and response to treatment. The overall quality of the studies was good. However, the wide range of tests assessed and the non-standardised reporting of diagnostic accuracy outcomes meant that statistical analysis was not possible.Some tests have shown promising results for identifying MCI and early dementia. However, concerns over small sample sizes, lack of replicability of studies, and lack of evidence available make it difficult to make recommendations on the clinical use of the computerised tests for diagnosing, monitoring progression, and treatment response for MCI and early dementia. Research is required to establish stable cut-off points for automated computerised tests used to diagnose patients with MCI or early dementia.
| S-EPMC5887872 | biostudies-other