scholarly journals The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis

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.

Author(s):  
Jon Genuneit ◽  
Sashini Jayasinghe ◽  
CARMEN RIGGIONI ◽  
Rachel Peters ◽  
Derek Chu ◽  
...  

Background: The European Academy of Allergy and Clinical Immunology (EAACI) is in the process of updating the guidelines on the diagnosis and management of food allergy. The existing guidelines are based on a systematic review of the literature until 30th September 2012. Therefore, a new systematic review must be undertaken to inform the new guidelines. This systematic review aims to assess the accuracy of index tests to support the diagnosis of IgE-mediated food allergy. Methods: The databases Cochrane CENTRAL (Trials), MEDLINE (OVID) and Embase (OVID) will be searched for diagnostic test accuracy studies from 1st October 2012 to 30th June 2021. Inclusion and exclusion criteria will be used to select appropriate studies. Data from these studies will be extracted and tabulated, and then reviewed for risk of bias and applicability using the QUADAS-2 tool. All evaluation will be done in duplicate. Studies with a high risk of bias and low applicability will be excluded. Meta-analysis will be performed if there are three or more studies of the same index test and food. Results: A protocol for the systematic review and meta-analyses is presented and was registered using Prospero prior to commencing the literature search. Discussion: Oral food challenges are the reference standard for diagnosis but involve considerable risks and resources. This protocol for systematic review aims to assess the accuracy of various tests to diagnose food allergy, which can be useful in both clinical and research settings.


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.


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.


2016 ◽  
Vol 31 (1) ◽  
pp. 1-10 ◽  
Author(s):  
Jung-Soo Pyo ◽  
Jin Hee Sohn ◽  
Woo Ho Kim

Purpose The aim of this study was to investigate the diagnostic accuracy of HER2 immunohistochemistry (IHC) in gastric carcinoma (GC) through a systematic review, meta-analysis and diagnostic test accuracy review. Method The current study included 12,679 GC cases and 181 subsets in 45 eligible studies. We performed concordance analysis between HER2 IHC and in situ hybridization (ISH) in GC. Diagnostic test accuracy was analyzed and the area under the curve (AUC) on the summary receiver operating characteristic (SROC) curve was calculated. Results HER2 amplification rates were 3.0%, 31.8%, and 93.0% in the IHC score 0/1+, 2+, and 3+ groups, respectively. The concordance rates between IHC and ISH were 0.969 (95% confidence interval [CI] 0.962-0.975), 0.393 (95% CI 0.331-0.458) and 0.915 (95% CI 0.882-0.939) in the HER2 IHC score 0/1+, 2+, and 3+ groups, respectively. For all the HER2 IHC score groups, the positive rates were higher in the silver ISH (SISH) subgroup than in the fluorescence ISH (FISH) and chromogenic ISH (CISH) subgroups. In diagnostic test accuracy review, the pooled sensitivity and specificity were 0.86 (95% CI 0.84-0.87) and 0.91 (95% CI 0.90-0.91). The AUC on SROC curve was 0.958. However, there was no significant difference in the values of AUC between the ISH methods. Conclusions Our results showed that HER2 IHC was well concordant with ISH in HER2 IHC score 0/1+ or 3+. Although this meta-analysis showed higher diagnostic accuracy of HER2 IHC, more detailed criteria for HER2 IHC score 2+ cases will be required to predict HER2 status.


Author(s):  
Buyun Xu ◽  
Yangbo Xing ◽  
Jiahao Peng ◽  
Zhaohai Zheng ◽  
Weiliang Tang ◽  
...  

Abstract OBJECTIVE: The purpose of this article was to perform a systematic review and meta- analysis regarding the diagnostic test accuracy of chest CT for detecting Coronavirus Disease 2019 (COVID-19).METHODS: PubMed, EMBASE, Web of Science and CNKI were searched up to March 12, 2020. We included studies providing information regarding diagnostic test accuracy of chest CT for COVID-19 detection. The methodologic quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies–2 tool. Sensitivity and specificity were pooled.RESULTS: Ten studies (n = 2657 patients) were included. The risks of bias in all studies were moderate in general. Pooled sensitivity was 93% (95% CI: 85 - 97%), and only one study reported specificity (25%, 95% CI:22-30%). There was substantial heterogeneity according to the Cochran Q test (p < 0.01) and Higgins I2 heterogeneity index (96% for sensitivity). After dividing the studies into two groups based on the study site, we found that the sensitivity of chest CT was great in Wuhan (the most affected city by the epidemic) and the sensitivity values were very close to each other (97%, 96% and 99%, respectively). In the regions other than Wuhan, the sensitivity varied from 69% to 98%.CONCLUSION: Chest CT offers the great sensitivity for detecting COVID-19, especially in region with severe epidemic situation. However, the specificity is low. In the context of emergency disease control, chest CT provide a fast, convenient and effective method to early recognize suspicious cases and might contribute to confine epidemic.


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