Summary Sensitivity Research Articles

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.

O031 Machine learning models in renal transplantation: a systematic review and meta-analysis of predictive performance in graft outcomes

Abstract Introduction Kidney transplantation (KT) is currently the renal replacement therapy of choice for most patients with end-stage kidney disease. Despite many advancements, the variations in outcome and frequent occurrence of graft failure continue to pose important clinical and research challenges. The aim of this study was to carry out a systematic review of the current application of Machine Learning (ML) models in KT and perform a meta-analysis of these models in the prediction of graft outcomes. Methods This review was registered with the PROSPERO database (CRD42021247469) and all peer reviewed and preprint original articles that reported the sensitivity and specificity of AI-based models were included in the meta-analysis. Data were analysed using MetaDTA,,an interactive online software for meta-analysis of diagnostic studies. The diagnostic performance of the meta-analysis was assessed by a summary receiver operating characteristics (sROC) plot. Results 38 studies met the inclusion criteria for the review and 12 studies met the inclusion criteria for the meta-analysis. The most common models used were artificial neural networks, decision trees and Bayesian belief networks. Seven studies compared the predictive performance of ML models with traditional regression methods. The summary sensitivity and specificity of ML-based models were 0.84 (95% CI, 0.72–0.91) and 0.68 (95% CI, 0.57–0.77), respectively. The area under the SROC for all the available evidence was 0.83. The Diagnostic Odds Ratio of ML models was 11.19 (95% CI 6.66–18.75). Conclusion Our study shows that ML models can accurately predict outcomes following KT by the integration of the vast amounts of available clinical data. Take-home message This study confirms the superior ability of ML Models in handling complex relationships between large datasets, features and outcomes, which has definitely led to improved precision and accuracy of outcomes.

Efficacy of MR diffusion kurtosis imaging for differentiating low-grade from high-grade glioma before surgery: A systematic review and meta-analysis

BackgroundAccurate discrimination and diagnosis of low-grade glioma (LGG) and high-grade glioma (HGG) before surgery is clinically important because it affects the patient’s outcome and guides the clinicians to select appropriate management. The aim of this study was to evaluate the diagnostic performance of diffusion kurtosis imaging (DKI) for differentiating LGG from HGG. MethodsA literature search of the PubMed, Web of Science, Cochrane Library and EMBASE databases was conducted up to December 15, 2020. Studies that evaluated the diagnostic performance of DKI for differentiating LGG from HGG were selected. Retrieved hits were evaluated by the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Summary sensitivity and specificity were determined, and the data analysis was performed using Stata 14.0 and Review Manager 5.3. ResultsThirteen studies with 705 patients were included. The individual sensitivity and specificity of the 13 studies varied from 71% to 100% for sensitivity and 73–100% for specificity. The pooled sensitivity of DKI was 88% (95% confidence interval [CI], 83–91%), and the pooled specificity was 91% (95% CI, 86–95%). The area under the summary receiver operating characteristic curve was 0.93 (95% CI, 0.90–0.95). The pooled diagnostic odds ratio of DKI was 64.85 (95% CI 38.52–109.19). The levels of heterogeneity for sensitivity and specificity across the included studies were high (I2 =66%) and mild (I2 =47.04%), respectively. The multiple subgroup analyses were driven by DKI technique and study region. ConclusionsDKI demonstrated a high diagnostic performance for differentiation of LGG from HGG.

Duplex ultrasound for diagnosing symptomatic carotid stenosis in the extracranial segments.

Duplex ultrasound for diagnosing symptomatic carotid stenosis in the extracranial segments.

Diagnostic accuracy of transient elastography in diagnosing clinically significant portal hypertension in patients with chronic liver disease: a systematic review and meta-analysis.

Liver stiffness measurement using transient elastography (TE-LSM) is a promising noninvasive alternative to hepatic venous pressure gradient (HVPG) for diagnosing clinically significant portal hypertension (CSPH). However, previous studies have yielded conflicting results. We evaluated the correlation between TE-LSM and HVPG and the performance of TE-LSM in diagnosing CSPH (HVPG ≥ 10mmHg). We conducted a systematic review and meta-analysis by searching PubMed and Scopus databases for relevant literature evaluating the clinical usefulness of TE for diagnosing CSPH in patients with chronic liver disease. Twenty-six studies (4337 patients with valid TE and HVPG) met our inclusion criteria. The median correlation coefficient of TE with HVPG was 0.70 (range 0.36-0.86). The weighted mean of optimal cut-off of liver stiffness value for diagnosing CSPH was 22.8kPa (95% CI 22.7-23.0kPa). The summary sensitivity and specificity were 79% (95% CI 74-84%) and 88% (95% CI 84-91%), respectively. The area under the hierarchical summary receiver operating characteristic (HSROC) curve was 0.91 (95% CI 0.88-0.93) according to the bivariate model. One limitation of the study was significant heterogeneity in the results of summary sensitivity and specificity (I2 83 and 74%, respectively). The heterogeneity could be explained by the variable liver stiffness cut-offs used in studies. The meta-regression plot revealed that as the optimal cut-off increased, the sensitivity decreased, the specificity increased, and vice versa. Liver stiffness measurement using TE correlates well with HVPG, and a liver stiffness cut-off value of 22.8kPa shows a high accuracy for diagnosing CSPH. Thus, use of TE should be integrated into clinical practice for noninvasive diagnosis of CSPH.

Withdrawn: Bing-Tian Dong, Yu-Ping Chen, Guo-Rong Lyu, Hua-Ming Wang, Guo-Fu Lin and Jiong-Hui Gu; Diagnostic accuracy of two-dimensional shear wave elastography and magnetic resonance elastography for staging liver fibrosis in patients with chronic hepatitis B: A systematic review and meta-analysis.

An accurate assessment of liver fibrosis is critical for the management of chronic hepatitis B (CHB) patients. Two-dimensional shear wave elastography (2D-SWE) and magnetic resonance elastography (MRE) have recently been proposed to diagnose liver fibrosis. To determine the optimal noninvasive method for diagnosing fibrosis in CHB, we conducted a meta-analysis to compare the performance of 2D-SWE and MRE for diagnosing fibrosis in patients with CHB. Literature databases were searched until January 1st 2021. Three measures, the summary area under the receiver operating characteristic curve (AUSROC), the summary diagnostic odds ratios, and the summary sensitivities and specificities, were used to assess the performance of 2D-SWE and MRE for detecting liver fibrosis. Twenty-four studies with 5126 CHB patients were included. The summary sensitivities and specificities of 2D-SWE and MRE were 82% and 81%, 91% and 94%, respectively, for detecting significant fibrosis, 88% and 85%, 93% and 93%, respectively, for detecting advanced fibrosis, and 89% and 87%, 92% and 92%, respectively, for detecting cirrhosis. The AUSROC value of MRE (0.97) in predicting significant fibrosis was significantly higher than those of 2D-SWE (0.88, P < 0.001). The AUSROC values of 2D-SWE and MRE were 0.93 and 0.98, respectively, for the diagnosis of advanced fibrosis, and 0.94 and 0.97, respectively, for the diagnosis of cirrhosis. MRE and 2D-SWE are excellent tools for staging fibrosis in patients with CHB. MRE probably exhibit the better diagnostic accuracy in detecting significant fibrosis as compared to 2D-SWE.

Elevated Cardiac Troponin to Detect Acute Cellular Rejection After Cardiac Transplantation: A Systematic Review and Meta-Analysis.

Cardiac troponin is well known as a highly specific marker of cardiomyocyte damage, and has significant diagnostic accuracy in many cardiac conditions. However, the value of elevated recipient troponin in diagnosing adverse outcomes in heart transplant recipients is uncertain. We searched MEDLINE (Ovid), Embase (Ovid), and the Cochrane Library from inception until December 2020. We generated summary sensitivity, specificity, and Bayesian areas under the curve (BAUC) using bivariate Bayesian modelling, and standardised mean differences (SMDs) to quantify the diagnostic relationship of recipient troponin and adverse outcomes following cardiac transplant. We included 27 studies with 1,684 cardiac transplant recipients. Patients with acute rejection had a statistically significant late elevation in standardised troponin measurements taken at least 1 month postoperatively (SMD 0.98, 95% CI 0.33–1.64). However, pooled diagnostic accuracy was poor (sensitivity 0.414, 95% CrI 0.174–0.696; specificity 0.785, 95% CrI 0.567–0.912; BAUC 0.607, 95% CrI 0.469–0.723). In summary, late troponin elevation in heart transplant recipients is associated with acute cellular rejection in adults, but its stand-alone diagnostic accuracy is poor. Further research is needed to assess its performance in predictive modelling of adverse outcomes following cardiac transplant. Systematic Review Registration: identifier CRD42021227861

Guaiac-based faecal occult blood tests versus faecal immunochemical tests for colorectal cancer screening in average-risk individuals.

Guaiac-based faecal occult blood tests versus faecal immunochemical tests for colorectal cancer screening in average-risk individuals.

Causal effects of psychosocial factors on chronic back pain: a bidirectional Mendelian randomisation study.

Risk factors for chronic back pain (CBP) may share underlying genetic factors, making them difficult to study using conventional methods. We conducted a bi-directional Mendelian randomisation (MR) study to examine the causal effects of risk factors (education, smoking, alcohol consumption, physical activity, sleep and depression) on CBP and the causal effect of CBP on the same risk factors. Genetic instruments for risk factors and CBP were obtained from the largest published genome-wide association studies (GWAS) of risk factor traits conducted in individuals of European ancestry. We used inverse weighted variance meta-analysis (IVW), Causal Analysis Using Summary Effect (CAUSE) and sensitivity analyses to examine evidence for causal associations. We interpreted exposure-outcome associations as being consistent with a causal relationship if results with IVW or CAUSE were statistically significant after accounting for multiple statistical testing (p < 0.003), and the direction and magnitude of effect estimates were concordant between IVW, CAUSE, and sensitivity analyses. We found evidence for statistically significant causal associations between greater education (OR per 4.2years of schooling = 0.54), ever smoking (OR = 1.27), greater alcohol consumption (OR = 1.29 per consumption category increase) and major depressive disorder (OR = 1.41) and risk of CBP. Conversely, we found evidence for significant causal associations between CBP and greater alcohol consumption (OR = 1.19) and between CBP and smoking (OR = 1.21). Other relationships did not meet our pre-defined criteria for causal association. Fewer years of schooling, smoking, greater alcohol consumption, and major depressive disorder increase the risk of CBP. CBP increases the risk of greater alcohol consumption and smoking.

Diagnostic value of smartphone in obstructive sleep apnea syndrome: A systematic review and meta-analysis.

ObjectivesTo assess the diagnostic utility of smartphone-based measurement in detecting moderate to severe obstructive sleep apnea syndrome (OSAS).MethodsSix databases were thoroughly reviewed. Random-effect models were used to estimate the summary sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio, summary receiver operating characteristic curve and measured the areas under the curve. To assess the accuracy and precision, pooled mean difference and standard deviation of apnea hypopnea index (AHI) between smartphone and polysomnography (95% limits of agreement) across studies were calculated using the random-effects model. Study methodological quality was evaluated using the QUADAS-2 tool.ResultsEleven studies were analyzed. The smartphone diagnostic odds ratio for moderate-to-severe OSAS (apnea/hypopnea index > 15) was 57.3873 (95% confidence interval [CI]: [34.7462; 94.7815]). The area under the summary receiver operating characteristic curve was 0.917. The sensitivity, specificity, negative predictive value, and positive predictive value were 0.9064 [0.8789; 0.9282], 0.8801 [0.8227; 0.9207], 0.9049 [0.8556; 0.9386], and 0.8844 [0.8234; 0.9263], respectively. We performed subgroup analysis based on the various OSAS detection methods (motion, sound, oximetry, and combinations thereof). Although the diagnostic odds ratios, specificities, and negative predictive values varied significantly (all p < 0.05), all methods afforded good sensitivity (> 80%). The sensitivities and positive predictive values were similar for the various methods (both p > 0.05). The mean difference with standard deviation in the AHI between smartphone and polysomnography was -0.6845 ± 1.611 events/h [-3.8426; 2.4735].ConclusionsSmartphone could be used to screen the moderate-to-severe OSAS. The mean difference between smartphones and polysomnography AHI measurements was small, though limits of agreement was wide. Therefore, clinicians should be cautious when making clinical decisions based on these devices.

Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin.

Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin.

Aspartate Aminotransferase to Platelet Ratio Index and Fibrosis-4 Index for Detecting Liver Fibrosis in Patients With Autoimmune Hepatitis: A Meta-Analysis

BackgroundAspartate aminotransferase-to-platelet ratio index (APRI) and fibrosis-4 index (FIB-4) are the two most widely studied noninvasive markers of liver fibrosis. We aimed to assess the diagnostic accuracy of APRI and FIB-4 for liver fibrosis in patients with autoimmune hepatitis (AIH) using liver biopsy as the reference standard.MethodsPubMed, EMBASE, Cochrane Library and Web of Science databases were searched for studies (published as of May 1st, 2021) that assessed the diagnostic performance of APRI and FIB-4 for liver fibrosis in AIH. The summary area under receiver operating characteristics curve (AUROC), sensitivity, specificity, diagnostic odds ratios were used to assess the diagnostic accuracy of APRI and FIB-4 for detecting liver fibrosis.ResultsFourteen studies (including 1015 patients) were selected with 13 studies each evaluating the use of APRI and FIB-4 for detecting different stages of fibrosis in AIH. For prediction of significant fibrosis, advanced fibrosis, and cirrhosis, the summary AUROC value was 0.66 [95% confidence interval (CI): 0.61–0.70], 0.71 (95% CI: 0.67–0.75), and 0.75 (95% CI: 0.71–0.79) for APRI, and the summary AUROC value was 0.75 (95% CI: 0.71–0.79), 0.73 (95% CI: 0.69–0.77) and 0.79 (95% CI: 0.75–0.82) for FIB-4, respectively. The summary sensitivity and specificity for diagnosis of significant fibrosis, advanced fibrosis, and cirrhosis were 90% and 36%, 78% and 55%, and 77% and 61% for APRI, and 70% and 70%, 65% and 70%, and 78% and 65% for FIB-4, respectively.ConclusionsAPRI and FIB-4 showed suboptimal diagnostic performance for identifying liver fibrosis in AIH with mediocre sensitivity and specificity.

Performance of adding hepatobiliary phase image in magnetic resonance imaging for detection of hepatocellular carcinoma: a meta-analysis.

To determine the performance of diagnostic algorithm of adding hepatobiliary phase (HBP) images in Gd-EOB-DTPA-enhanced MRI for the detection of hepatocellular carcinoma (HCC) measuring up to 3 cm in patients with chronic liver disease. We searched multiple databases from inception to April 10, 2020, to identify studies on using Gd-EOB-DTPA-enhanced MRI for the diagnostic accuracy of HCC (≤ 3 cm) in patients with chronic liver disease. The diagnostic algorithm of Gd-EOB-DTPA-enhanced MRI with HBP for HCC was defined as a nodule showing hyperintensity during arterial phase and hypointensity during the portal venous, delayed, or hepatobiliary phases. For gadoxetic acid-enhanced MRI without HBP, the diagnostic criteria were a nodule showing arterial enhancement and hypointensity on the portal venous or delayed phases. The data were extracted to calculate summary estimates of sensitivity, specificity, diagnostic odds ratio, likelihood ratio, and summary receiver operating characteristic (sROC) by using a bivariate random-effects model. Twenty-nine studies with 2696 HCC lesions were included. Overall Gd-EOB-DTPA-enhanced MRI with HBP had a sensitivity of 87%, specificity of 92%, and the area under the sROC curve of 95%. The summary sensitivity of Gd-EOB-DTPA-enhanced MRI with HBP was significantly higher than that without HBP (84% vs 68%, p = 0.01). Gd-EOB-DTPA-enhanced MRI with HBP showed higher sensitivity than that without HBP and had comparable specificity for diagnosis of HCC in patients with chronic liver disease. • Hypointensity on HBP is a major feature for diagnosis of HCC. • Extending washout appearance to the transitional or hepatobiliary phase on Gd-EOB-DTPA provides favorable sensitivity and comparable specificity for diagnosis HCC. • The summary sensitivity of gadoxetic acid-enhanced MRI with HBP was significantly higher than that without HBP (84% vs 68%, p = 0.01) for diagnosis of HCC in patients with chronic liver disease.

Diagnostic accuracy of dual-energy computed tomography (DECT) to detect non-traumatic bone marrow edema: A systematic review and meta-analysis

PurposeThis meta-analysis aimed to evaluate the diagnostic performance of dual-energy computed tomography (DECT) for detecting bone marrow edema (BME) in non-traumatic patients. MethodsA systematic search of PubMed, EMBASE, and the Cochrane Library databases was performed up to October 1, 2021 for relevant original studies. Study details were extracted by two independent reviewers. A bivariate mixed-effects regression model was used to assess comprehensive diagnostic performance, and a subgroup analysis was performed to evaluate sources of variability. The risk of bias was evaluated with the QUADAS-2 tool. ResultsTen studies involving 2463 regions, including hands, ankles, hips, and sacroiliac joints, were evaluated in this meta-analysis. Summary sensitivity, specificity, and area under the receiver operating characteristic curve values for BME were 88.4% (95% confidence interval (CI) 82.4%–92.5%), 96.1% (95% CI 94.4%–97.3%), and 0.98 (95% CI 96%–99%), respectively. The subgroup analysis showed that studies using a thicker slice (≥1 mm) had a higher sensitivity, and studies with older patients (≥60 years), fewer included patients (<40), and bones other than the pelvis had a higher specificity. Studies presented a generally low or unclear risk for bias and applicability concerns. ConclusionsDECT has an excellent diagnostic performance for detecting BME in non-traumatic patients and may provide an alternative to magnetic resonance imaging (MRI) for the detection of non-traumatic BME in the future, especially when MRI is unavailable or contraindicated.

Diagnostic Accuracy of Shear-Wave Elastography for Breast Lesion Characterization in Women: A Systematic Review and Meta-Analysis.

The aim of this study was to assess the diagnostic accuracy of 2-D shear-wave elastography (SWE) for differentiating benign and malignant breast lesions in women with abnormal findings on mammography. Included in this review are studies of diagnostic accuracy published before June 2021 using 2-D SWE to evaluate female breast lesions. Included studies were required to include at least 50 lesions, report quantitative shear-wave speed (SWS) thresholds, and include a reference standard of either biopsy or 2-year stability. Included studies used the mean, maximum, minimum, or SD of SWS for classification. A systematic search of PubMed, Scopus, Embase, Ovid-MEDLINE, the Cochrane Library, and Web of Science was performed. Bias and applicability of the studies were assessed using Quality Assessment of Diagnostic Accuracy Studies 2. A hierarchical summary receiver operating characteristic model was used to arrive at the summary statistics. Eighty-seven prospective and retrospective studies were included, encompassing 17,810 women (mean age 42.3 ± 10.4 years) with 19,043 lesions (7,623 malignant). Summary sensitivities and specificities, respectively, were 0.86 (95% confidence interval [CI], 0.83-0.88) and 0.87 (95% CI, 0.84-0.88) for mean SWS, 0.83 (95% CI, 0.80-0.85) and 0.88 (95% CI, 0.86-0.90) for the maximum, 0.86 (95% CI, 0.74-0.93) and 0.81 (95% CI, 0.69-0.89) for the minimum, and 0.82 (95% CI, 0.77-0.86) and 0.88 (95% CI, 0.85-0.91) for the SD. Alternatively, the areas under the receiver operating characteristic curve were 0.93 (95% CI, 0.91-0.94), 0.92 (95% CI, 0.90-0.94), 0.90 (95% CI, 0.82-0.96), and 0.92 (95% CI, 0.88-0.94), respectively. This review demonstrates the discriminative power of SWE in the diagnosis of breast cancer. Using the resulting likelihood ratios, SWE may prove beneficial in downgrading BI-RADS® 4a or upgrading BI-RADS 3 lesions. However, current society guidelines do not provide definitive recommendations regarding the use of SWE and its counterpart strain elastography (SE). Comparison with our results suggests that SE alone or a combination of SE and SWE may provide better diagnostic performance than SWE alone and serve as an adjunct to current diagnostic techniques.

Rs-fMRI and machine learning for ASD diagnosis: a systematic review and meta-analysis

Autism Spectrum Disorder (ASD) diagnosis is still based on behavioral criteria through a lengthy and time-consuming process. Much effort is being made to identify brain imaging biomarkers and develop tools that could facilitate its diagnosis. In particular, using Machine Learning classifiers based on resting-state fMRI (rs-fMRI) data is promising, but there is an ongoing need for further research on their accuracy and reliability. Therefore, we conducted a systematic review and meta-analysis to summarize the available evidence in the literature so far. A bivariate random-effects meta-analytic model was implemented to investigate the sensitivity and specificity across the 55 studies that offered sufficient information for quantitative analysis. Our results indicated overall summary sensitivity and specificity estimates of 73.8% and 74.8%, respectively. SVM stood out as the most used classifier, presenting summary estimates above 76%. Studies with bigger samples tended to obtain worse accuracies, except in the subgroup analysis for ANN classifiers. The use of other brain imaging or phenotypic data to complement rs-fMRI information seems promising, achieving higher sensitivities when compared to rs-fMRI data alone (84.7% versus 72.8%). Finally, our analysis showed AUC values between acceptable and excellent. Still, given the many limitations indicated in our study, further well-designed studies are warranted to extend the potential use of those classification algorithms to clinical settings.

Point-of-care testing for tetanus immunity: a systematic review and meta-analysis

BackgroundThe current standard of care for tetanus prophylaxis management in patients with open wounds likely results in overtreatment and unnecessary costs. Point-of-care immunochromatographic tests, known as Tetanus Quick Sticks (TQS),...

Symptom- and chest-radiography screening for active pulmonary tuberculosis in HIV-negative adults and adults with unknown HIV status.

Symptom- and chest-radiography screening for active pulmonary tuberculosis in HIV-negative adults and adults with unknown HIV status.

Diagnostic performance of fractional flow reserve derived from coronary angiography, intravascular ultrasound, and optical coherence tomography; a meta-analysis

BackgroundLittle is known about the overall diagnostic performance of computational fractional flow reserve (FFR) derived from angiography (Angio-FFR), intravascular ultrasound (IVUS-FFR), and optical coherence tomography (OCT-FFR) to detect hemodynamically significant coronary artery disease. The present study aimed to evaluate the diagnostic performance of those novel physiologic indices using conventional FFR as the gold standard. MethodsPubMed and Embase were searched in September 2021 for a systematic review and meta-analysis of studies assessing the diagnostic performance of invasive imaging-derived FFR. The primary outcomes were the summary sensitivity, specificity, correlation coefficients of each index. ResultsA total of 6572 records were initially identified and 49 studies were included in the final analysis (7010 lesions from 36 studies for Angio-FFR, 305 lesions from 5 studies for IVUS-FFR, and 667 lesions from 8 studies for OCT-FFR). Invasive imaging-derived FFR had a high diagnostic performance to detect functionally significant coronary lesions using conventional FFR as the gold standard [Angio-FFR, sensitivity 0.87 (95% CI 0.84–0.89), specificity 0.93 (95% CI 0.910.95); IVUS-FFR, sensitivity 0.90 (95% CI 0.84–0.94), specificity 0.95 (95% CI 0.90–0.98); OCT-FFR, sensitivity 0.85 (95% CI 0.78–0.91), specificity 0.93 (95% CI 0.89–0.95)]. The summary correlation coefficients of Angio-, IVUS-, and OCT-FFRs with wire-based FFR were 0.83 (95% CI 0.80–0.85), 0.85 (95% CI 0.79–0.91), and 0.80 (95% CI 0.74–0.86), respectively. ConclusionsThis meta-analysis demonstrated that computational FFR derived from invasive coronary imaging has clinically acceptable diagnostic performances irrespective of modalities, supporting their applicability to clinical practice.

Point-of-care viral load tests to detect high HIV viral load in people living with HIV/AIDS attending health facilities.

BackgroundViral load (VL) testing in people living with HIV (PLHIV) helps to monitor antiretroviral therapy (ART). VL is still largely tested using central laboratory‐based platforms, which have long test turnaround times and involve sophisticated equipment. VL tests with point‐of‐care (POC) platforms capable of being used near the patient are potentially easy to use, give quick results, are cost‐effective, and could replace central or reference VL testing platforms.ObjectivesTo estimate the diagnostic accuracy of POC tests to detect high viral load levels in PLHIV attending healthcare facilities.Search methodsWe searched eight electronic databases using standard, extensive Cochrane search methods, and did not use any language, document type, or publication status limitations. We also searched the reference lists of included studies and relevant systematic reviews, and consulted an expert in the field from the World Health Organization (WHO) HIV Department for potentially relevant studies. The latest search was 23 November 2020.Selection criteriaWe included any primary study that compared the results of a VL test with a POC platform to that of a central laboratory‐based reference test to detect high viral load in PLHIV on HIV/AIDS care or follow‐up. We included all forms of POC tests for VL as defined by study authors, regardless of the healthcare facility in which the test was conducted. We excluded diagnostic case‐control studies with healthy controls and studies that did not provide sufficient data to create the 2 × 2 tables to calculate sensitivity and specificity. We did not limit our study inclusion to age, gender, or geographical setting.Data collection and analysisTwo review authors independently screened the titles, abstracts, and full texts of the search results to identify eligible articles. They also independently extracted data using a standardized data extraction form and conducted risk of bias assessment using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS‐2) tool. Using participants as the unit of analysis, we fitted simplified univariable models for sensitivity and specificity separately, employing a random‐effects model to estimate the summary sensitivity and specificity at the current and commonly reported World Health Organization (WHO) threshold (≥ 1000 copies/mL). The bivariate models did not converge to give a model estimate.Main resultsWe identified 18 studies (24 evaluations, 10,034 participants) defining high viral loads at main thresholds ≥ 1000 copies/mL (n = 20), ≥ 5000 copies/mL (n = 1), and ≥ 40 copies/mL (n = 3). All evaluations were done on samples from PLHIV retrieved from routine HIV/AIDS care centres or health facilities. For clinical applicability, we included 14 studies (20 evaluations, 8659 participants) assessing high viral load at the clinical threshold of ≥ 1000 copies/mL in the meta‐analyses. Of these, sub‐Saharan Africa, Europe, and Asia contributed 16, three, and one evaluation respectively. All included participants were on ART in only nine evaluations; in the other 11 evaluations the proportion of participants on ART was either partial or not clearly stated. Thirteen evaluations included adults only (n = 13), five mixed populations of adults and children, whilst in the remaining two the age of included populations was not clearly stated. The majority of evaluations included commercially available tests (n = 18). Ten evaluations were POC VL tests conducted near the patient in a peripheral or onsite laboratory, whilst the other 10 were evaluations of POC VL tests in a central or reference laboratory setting. The test types evaluated as POC VL tests included Xpert HIV‐1 Viral Load test (n = 8), SAMBA HIV‐1 Semi‐Q Test (n = 9), Alere Q NAT prototype assay for HIV‐1 (n = 2) and m‐PIMA HIV‐1/2 Viral Load test (n = 1). The majority of evaluations (n = 17) used plasma samples, whilst the rest (n = 3) utilized whole blood samples.Pooled sensitivity (95% confidence interval (CI)) of POC VL at a threshold of ≥ 1000 copies/mL was 96.6% (94.8 to 97.8) (20 evaluations, 2522 participants), and pooled specificity (95% CI) was 95.7% (90.8 to 98.0) (20 evaluations, 6137 participants). Median prevalence for high viral load (≥ 1000 copies/mL) (n = 20) was 33.4% (range 6.9% to 88.5%).LimitationsThe risk of bias was mostly assessed as unclear across the four domains due to incomplete reporting.Authors' conclusionsWe found POC VL to have high sensitivity and high specificity for the diagnosis of high HIV viral load in PLHIV attending healthcare facilities at a clinical threshold of ≥ 1000 copies/mL.