scholarly journals Diagnostic Accuracy of Antibody-based Rapid Diagnostic Test in Detecting Coronavirus Disease 2019: Systematic Review

Author(s):  
Yanto Tjang ◽  
Tiara Gracienta ◽  
Ryan Herardi ◽  
Frans Santosa ◽  
Taufiq Pasiak

IntroductionThe rapid transmission of Coronavirus disease 2019 (COVID-19) requires a fast, accurate, and affordable detection method. Despite doubts of its diagnostic accuracy, Rapid Diagnostic Test (RDT) is world-widely used in consideration for its practicality. This systematic review aims to determine the diagnostic accuracy of antibody-based RDT in detecting COVID-19.Material and methodsA literature search was carried out on five journal databases using the PRISMA-P 2015 method. We included all studies published up to February 2021. The risk of bias was evaluated using The Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Diagnostic Test Accuracy Studies. Data regarding peer-review status, study design, tests kit information, immunoglobulin class, target antigen, and the number of samples were extracted and tabulated. We estimated the pooled sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with a 95% confidence interval.ResultsThirty-three studies met the eligibility criteria. The pooled data results showed that the combined detection method of IgM or IgG had the highest sensitivity and NPV, which were 73.41% (95% CI: 72.22-74.57) and 75.34% (95% CI: 74.51-76.16), respectively. The single IgG detection method had the highest specificity and PPV of 96.68% (95% CI: 96.25-97.07) and 95.97% (95% CI: 95.47-96.42%), respectively.ConclusionsAntibody-based RDT is not satisfactory as a primary diagnostic test but has utilities as a screening tool.

2020 ◽  
Vol 7 (1) ◽  
pp. e000355 ◽  
Author(s):  
Rohit Hariharan ◽  
Mark Jenkins

BackgroundCirculating tumour DNA from colorectal cancer (CRC) is a biomarker for early detection of the disease and therefore potentially useful for screening. One such biomarker is the methylated SEPT9 (mSEPT9) gene, which occurs during CRC tumourigenesis. This systematic review and meta-analysis aims to establish the sensitivity, specificity and accuracy of mSEPT9 tests for the early diagnosis of CRC.MethodsA systematic search of the relevant literature was conducted using Medline and Embase databases. Data were extracted from the eligible studies and analysed to estimate pooled sensitivity, specificity and diagnostic test accuracy.ResultsBased on 19 studies, the pooled estimates (and 95% CIs) for mSEPT9 to detect CRC were: sensitivity 69% (62–75); specificity 92% (89–95); positive likelihood ratio 9.1 (6.1–13.8); negative likelihood ratio 0.34 (0.27–0.42); diagnostic OR 27 (15–48) and area under the curve 0.89 (0.86–0.91). The test has a positive predictive value of 2.6% and negative predictive value of 99.9% in an average risk population (0.3% CRC prevalence), and 9.5% (positive predictive value) and 99.6% (negative predictive value) in a high-risk population (1.2% CRC prevalence).ConclusionThe mSEPT9 test has high specificity and moderate sensitivity for CRC and is therefore a potential alternative screening method for those declining faecal immunochemical test for occult blood (FIT) or other screening modalities. However, it is limited by its poor diagnostic performance for precancerous lesions (advanced adenomas and polyps) and its relatively high costs, and little is known about its acceptability to those declining to use the FIT.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pakpoom Subsoontorn ◽  
Manupat Lohitnavy ◽  
Chuenjid Kongkaew

AbstractMany recent studies reported coronavirus point-of-care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy was used as a guideline for conducting this systematic review. We searched peer-reviewed and preprint articles in PubMed, BioRxiv and MedRxiv up to 28 September 2020 to identify studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was applied for assessing quality of included studies and Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) was followed for reporting. We included 81 studies from 65 research articles on POCTs of SARS, MERS and COVID-19. Most studies had high risk of patient selection and index test bias but low risk in other domains. Diagnostic specificities were high (> 0.95) for included studies while sensitivities varied depending on type of assays and sample used. Most studies (n = 51) used reverse transcription loop-mediated isothermal amplification (RT-LAMP) to diagnose coronaviruses. RT-LAMP of RNA purified from COVID-19 patient samples had pooled sensitivity at 0.94 (95% CI: 0.90–0.96). RT-LAMP of crude samples had substantially lower sensitivity at 0.78 (95% CI: 0.65–0.87). Abbott ID Now performance was similar to RT-LAMP of crude samples. Diagnostic performances by CRISPR and RT-LAMP on purified RNA were similar. Other diagnostic platforms including RT- recombinase assisted amplification (RT-RAA) and SAMBA-II also offered high sensitivity (> 0.95). Future studies should focus on the use of un-bias patient cohorts, double-blinded index test and detection assays that do not require RNA extraction.


2019 ◽  
Vol 36 (1) ◽  
pp. e4.2-e4
Author(s):  
Caitlin Wilson ◽  
Clare Harley ◽  
Stephanie Steels

BackgroundPre-hospital clinicians are involved in examining, treating and diagnosing patients. The accuracy of pre-hospital diagnoses is evaluated using diagnostic accuracy studies. We undertook a systematic review of published literature to provide an overview of how accurately pre-hospital clinicians diagnose patients compared to hospital doctors. A bivariate meta-analysis was incorporated to examine the range of diagnostic sensitivity and specificity.MethodsWe searched MEDLINE, CINAHL, Embase, AMED and the Cochrane Database of Systematic Reviews from 1946 to 7th May 2016 for studies where patients had been given a diagnosis by pre-hospital clinicians and hospital doctors. Key words focused on study type (‘diagnostic accuracy’), outcomes (sensitivity, specificity, likelihood ratio?, predictive value?) and setting (paramedic*, pre-hospital, ambulance, ‘emergency service?’, ‘emergency medical service?’, ‘emergency technician?’). The sole researcher screened titles and abstracts to ensure eligibility criteria were met, as well as assessing methodological quality using QUADAS-2.Results2941 references were screened by title and/or abstract. Eleven studies encompassing 3 84 985 patients were included after full-text review. The types of diagnoses in one of the studies encompassed all possible diagnoses and in the other studies focused on sepsis, stroke and myocardial infarction. Sensitivity estimates ranged from 32%–100% and specificity estimates from 14%–100%. Eight of the studies were deemed to have a low risk of bias and were incorporated into a meta-analysis, which showed a pooled sensitivity of 0.74 (0.62, 0.82) and a pooled specificity of 0.94 (0.87, 0.97).ConclusionsCurrent published research suggests that diagnoses made by pre-hospital clinicians have high sensitivity and even higher specificity. However, the paucity and varying quality of eligible studies indicates that further pre-hospital diagnostic accuracy studies are warranted especially in the field of non-life-threatening conditions and trauma.


2020 ◽  
pp. 105477382096123
Author(s):  
Jinkyung Park ◽  
Eunhye Jeong ◽  
Juneyoung Lee

Delirium is a reversible impairment of metabolism in the human brain. Early detection is important, and an effective screening tool for nurses is crucial. The Delirium Observation Screening (DOS) scale is one such screening tool; however, its diagnostic test accuracy has not yet been thoroughly examined. This study, therefore, aimed to evaluate the accuracy of the scale through a systematic review and meta-analysis. In July 2019, a search was conducted in the MEDLINE, CINAHL, Embase, and PsycARTICLES databases, and following a review against pre-defined eligibility criteria, eight studies were finally included. The quality assessment tool of diagnostic accuracy studies was applied to each study and a hierarchical regression model was used to calculate the pooled estimates of sensitivity (90%; 76%–97%, CI 95%) and specificity (92%; 88%–94%, CI 95%). The findings indicated a high diagnostic test accuracy for the DOS scale.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Yanli Zhu ◽  
Yuntao Song ◽  
Guohui Xu ◽  
Zhihui Fan ◽  
Wenhao Ren

Abstract Objective FNA is a simple, safe, cost-effective and accurate diagnostic tool for the initial screening of patients with thyroid nodules. The aims of this study were to determine the diagnostic utility of FNAC performed in our institution, assess the cytomorphologic features that contribute to diagnostic errors and propose improvement measures. Methods A total of 2781 FNACs were included in the study, and 1122 cases were compared with their histological diagnoses. We retrospectively reexamined our discordant (both false-negative and false-positive) cases and performed a systematic review of previous studies on causes of misdiagnoses. Results When DC V and DC VI were both considered cytologic-positive, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy were 98.3, 30.9, 94.9, 58.3 and 93.5%, respectively. If DC VI was considered cytologic-positive, the sensitivity, specificity, PPV, NPV and diagnostic accuracy of FNAC were 98.0, 84.0, 99.4, 58.3, and 97.5% respectively. The main cause of false-negative diagnoses was sampling error (13/15, 86.7%), while interpretation error led to the majority of the false-positive diagnoses (38/47, 80.9%). Overlapping cytological features in adenomatous hyperplasia, thyroiditis and cystic lesions were the major factors contributing to interpretation errors, while the size and number of nodules may have led to false-negative diagnoses because of heterogeneity and unsampled areas. Conclusions The sensitivity and PPV of thyroid FNAC in our institution were higher than those in the published data, while the specificity and NPV were lower. Regarding the FNA category DC V, a frozen section analysis during diagnostic lobectomy is necessary. Multiple passes should be performed in various parts of a large nodule or from different nodules to reduce the risk of false-negative findings. Cytopathologists should strengthen their criteria for the identification of adenomatous hyperplasia, thyroiditis and cystic lesions to avoid false-positive diagnoses. NIFTP has little effect on diagnostic accuracy and the distribution of diagnostic errors.


2020 ◽  
Author(s):  
Zoë Tieges ◽  
Alasdair M J Maclullich ◽  
Atul Anand ◽  
Claire Brookes ◽  
Marica Cassarino ◽  
...  

Abstract Objective Detection of delirium in hospitalised older adults is recommended in national and international guidelines. The 4 ‘A’s Test (4AT) is a short (<2 minutes) instrument for delirium detection that is used internationally as a standard tool in clinical practice. We performed a systematic review and meta-analysis of diagnostic test accuracy of the 4AT for delirium detection. Methods We searched MEDLINE, EMBASE, PsycINFO, CINAHL, clinicaltrials.gov and the Cochrane Central Register of Controlled Trials, from 2011 (year of 4AT release on the website www.the4AT.com) until 21 December 2019. Inclusion criteria were: older adults (≥65 years); diagnostic accuracy study of the 4AT index test when compared to delirium reference standard (standard diagnostic criteria or validated tool). Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Pooled estimates of sensitivity and specificity were generated from a bivariate random effects model. Results Seventeen studies (3,702 observations) were included. Settings were acute medicine, surgery, a care home and the emergency department. Three studies assessed performance of the 4AT in stroke. The overall prevalence of delirium was 24.2% (95% CI 17.8–32.1%; range 10.5–61.9%). The pooled sensitivity was 0.88 (95% CI 0.80–0.93) and the pooled specificity was 0.88 (95% CI 0.82–0.92). Excluding the stroke studies, the pooled sensitivity was 0.86 (95% CI 0.77–0.92) and the pooled specificity was 0.89 (95% CI 0.83–0.93). The methodological quality of studies varied but was moderate to good overall. Conclusions The 4AT shows good diagnostic test accuracy for delirium in the 17 available studies. These findings support its use in routine clinical practice in delirium detection. PROSPERO Registration number CRD42019133702.


2021 ◽  
Author(s):  
Ashley K. Matthies ◽  
Michael M. Trauer ◽  
Karl Chopra ◽  
Robert Jarman

AbstractBackgroundPoint-of-care (POC) lung ultrasound (LUS) is widely used in the emergency setting and there is an established evidence base across a range of respiratory diseases, including previous viral epidemics. The necessity for rapid testing combined with the limitations of other diagnostic tests has led to the proposal of various potential roles for LUS during the COVID-19 pandemic. This systematic review and meta-analysis focused specifically on the diagnostic accuracy of LUS in adult patients presenting with suspected COVID-19.MethodsTraditional and grey-literature searches were performed on June 1st 2021. Two authors independently carried out the searches, selected studies and completed the Quality Assessment Tool for Diagnostic Test Accuracy Studies (QUADAS-2). Meta-analysis was carried out using established open-source packages in R. We report overall sensitivity, specificity, positive and negative predictive values and the hierarchical summary receiver operating characteristic curve for LUS. Heterogeneity was determined using the I2 statistic.ResultsTwenty studies were included, providing data from a total of 4,314 patients. The prevalence and admission rates were generally high across all studies. Overall LUS was found to be 87.2% sensitive (95% CI 83.6-90.2) and 69.5% specific (95% CI 62.2-72.5) and demonstrated overall positive and negative predictive values of 3.0 (95% 2.3-4.1) and 0.16 (95% 0.12-0.22) respectively. Separate analyses for each reference standard revealed similar sensitivities and specificities for LUS. Heterogeneity between studies was found to be high, and QUADAS-2 assessment identified risks of bias in many studies.ConclusionDuring a period of high prevalence, LUS is a highly sensitive diagnostic test for COVID-19. However, more research is required to confirm these results in more generalisable populations, including those less likely to be admitted to hospital.


2019 ◽  
Author(s):  
Glenn-Milo Santos ◽  
Steffanie Strathdee ◽  
Nabila El-Bassel ◽  
Poonam Patel ◽  
Divya Subramanian ◽  
...  

Abstract Background Synthesis of psychometric properties of substance use measures to identify patterns of use and substance use disorders remains limited. To address this gap, we sought to systematically evaluate the psychometric properties of measures to detect substance use and misuse. Methods We conducted a systematic review and meta-analysis of literature on measures of substance classes associated with HIV risk (heroin, methamphetamine, cocaine, ecstasy, alcohol) that were published in English before June 2016 that reported at least one of the following psychometric outcomes of interest: internal consistency (alpha), test-retest/inter-rater reliability (kappa), sensitivity, specificity, positive predictive value, and negative predictive value. We used meta-analytic techniques to generate pooled summary estimates for these outcomes using random effects and hierarchical logistic regression models. Results Findings across 387 paper revealed that overall, 65% of pooled estimates for alpha were in the range of fair-to-excellent; 44% of estimates for kappa were in the range of fair-to-excellent. In addition, 69%, 97%, 37% and 96% of pooled estimates for sensitivity, specificity, positive predictive value, and negative predictive value, respectively, were in the range of moderate-to-excellent. Conclusion We conclude that many substance use measures had pooled summary estimates that were at the fair/moderate-to-excellent range across different psychometric outcomes. Most scales were conducted in English, within the United States, highlighting the need to test and validate these measures in more diverse settings. Additionally, the majority of studies had high risk of bias, indicating a need for more studies with higher methodological quality.


2011 ◽  
Vol 37 (9) ◽  
pp. 879-887 ◽  
Author(s):  
T. O. Smith ◽  
B. T. Drew ◽  
A. P. Toms ◽  
A. J. Chojnowski

The purpose of this study was to evaluate the diagnostic test accuracy of X-ray arthrography in the detection of TFCC tear. Both published and unpublished databases were searched from their inception to August 2010. All studies comparing the diagnostic accuracy of X-ray arthrography (index test) to arthroscopy (reference standard) for patients with suspected TFCC tears were included in this review. Twelve studies assessing 430 patients (430 wrists) satisfied the eligibility criteria and were included. X-ray arthrography presented with a pooled sensitivity of 76.2% and specificity of 92.5% for the detection of complete TFCC tear. The triple-compartment injection X-ray arthrography was superior to the single-compartment injection technique. To conclude, the diagnostic test accuracy of X-ray arthrography is limited. Neither the single- nor the triple-compartment injection arthrography method is acceptable, given their reported low sensitivities. Further evaluation of the diagnostic test accuracy of Magnetic Resonance Arthrography and Magnetic Resonance Imaging is therefore warranted.


2021 ◽  
Vol 10 (13) ◽  
pp. 2799
Author(s):  
Krzysztof Więckowski ◽  
Tomasz Gallina ◽  
Andrzej Surdacki ◽  
Bernadeta Chyrchel

Coronary artery disease is a global challenge for healthcare systems. Early diagnosis is a key issue to improve quality of life and reduce morbidity and mortality. Diagonal earlobe crease, a wrinkle extending obliquely across the earlobe, was linked by many authors to various atherosclerotic diseases. This systematic review aimed at summarizing the diagnostic accuracy of diagonal earlobe crease for diagnosis of chronic and acute coronary syndromes in adults. Cochrane’s recommendations for systematic reviews of diagnostic test accuracy studies were followed. The protocol was registered on PROSPERO. Seven electronic databases were searched up to April 2021. The risk of bias and applicability were assessed using the QUADAS-2 tool. Meta-analysis was not performed. Finally, 13 cross-sectional studies evaluating 3951 patients were analyzed, all of which focused on chronic coronary syndromes defined as anatomically significant coronary stenosis. Invasive coronary angiography was used as a reference in most studies, except one which utilized computed tomography angiography. Sensitivity ranged from 26% to 90%, and specificity from 32% to 96%. Positive likelihood ratios varied from 1.11 to 7.03, but most results were below 2. Negative likelihood ratios were from 0.84 to 0.30, but most values exceeded 0.5. Diagnostic accuracy of diagonal earlobe crease for the detection of chronic coronary syndromes is insufficient. It only slightly changes pre-test probability, and its mere presence or absence should not affect the clinical management of the patients. However, for its feasibility and easy interpretation, Frank’s sign could be considered as a part of physical examination.


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