Synovasure ‘quick test’ is not as accurate as the laboratory-based α-defensin immunoassay

Aims α-defensin is a biomarker which has been described as having a high degree of accuracy in the diagnosis of periprosthetic joint infection (PJI). Current meta-analyses are based on the α-defensin laboratory-based immunoassay rather than the quick on-table lateral flow test kit. This study is the first meta-analysis to compare the accuracy of the α-defensin laboratory-based immunoassay and the lateral flow test kit for the diagnosis of PJI. Materials and Methods A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Inclusion criteria were all clinical studies where the diagnosis of PJI was uncertain. All studies selected used the Musculoskeletal Infection Society (MSIS) or modified MSIS criteria. Two independent reviewers reviewed the studies and extracted data. A meta-analysis of results was carried out: pooled sensitivity, specificity, positive and negative likelihood ratio, heterogeneity and areas under curves are reported. Results Ten studies (759 patients) were included. Of these, seven studies (640 patients) evaluated the laboratory-based α-defensin immunoassay and three (119 patients) the lateral flow test. The pooled sensitivity and specificity of the qualitative α-defensin laboratory immunoassay was 0.953 (95% confidence interval (CI) 0.87 to 0.984) and 0.965 (95% CI 0.943 to 0.979) respectively. The pooled positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 34.86 (95% CI 19.34 to 62.85) and 0.02 (95% CI 0.00 to 0.11). The pooled sensitivity and specificity of the lateral flow test were 0.774 (95% CI 0.637 to 0.870) and 0.913 (95% CI 0.828 to 0.958), respectively. The pooled PLR and NLR were 8.675 (95% CI 4.229 to 17.794) and 0.248 (95% CI 0.147 to 0.418), respectively. Conclusion The pooled sensitivity and specificity of the lateral flow test were lower than those of the α-defensin laboratory-based immunoassay test. Hence, care must be taken with interpretation of the lateral flow test when relying on its results for the intra-operative diagnosis of PJI. Cite this article: Bone Joint J 2018;100-B:66–72.

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Evaluation of Lateral-Flow Assay for Rapid Detection of Influenza Virus

BioMed Research International ◽

10.1155/2020/3969868 ◽

2020 ◽

Vol 2020 ◽

pp. 1-16 ◽

Cited By ~ 1

Author(s):

Meng-Yi Han ◽

Tian-Ao Xie ◽

Jia-Xin Li ◽

Hui-Jin Chen ◽

Xiao-Hui Yang ◽

...

Keyword(s):

Influenza Virus ◽

Likelihood Ratio ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

Relevant Literature ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Lateral Flow ◽

Lateral Flow Assay ◽

Cochrane Library

Background. Influenza virus mainly causes acute respiratory infections in humans. However, the diagnosis of influenza is not accurate based on clinical evidence, as the symptoms of flu are similar to other respiratory virus. The lateral-flow assay is a rapid method to detect influenza virus. But the effectiveness of the technique in detecting flu viruses is unclear. Hence, a meta-analysis would be performed to evaluate the accuracy of LFA in detecting influenza virus. Methods. Relevant literature was searched out in PubMed, Embase, Web of Science, and Cochrane Library databases with the keywords “lateral flow assay” and “flu virus”. By Meta-DiSc software, pooled sensitivity, pooled specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), summary receiver operating characteristic curve (SROC), and area under the curve (AUC) can be calculated. Results. This meta-analysis contains 13 studies and 24 data. The pooled sensitivity and specificity of the influenza virus detected by LFA were 0.84 (95% CI: 0.82-0.86) and 0.97 (95% CI: 0.97-0.98), respectively. The pooled values of PLR, NLR, DOR, and SROC were 32.68 (17.16-62.24), 0.17 (0.13-0.24), 334.07 (144.27-773.53), and 0.9877. No publication bias was found. Conclusions. LFA exhibited high sensitivity and specificity in diagnosing influenza virus. It is a valuable alternative method which can diagnose influenza virus quickly. However, more evidence is required to confirm whether LFA is comparable to traditional methods for detecting the virus.

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Does the Alpha Defensin ELISA Test Perform Better Than the Alpha Defensin Lateral Flow Test for PJI Diagnosis? A Systematic Review and Meta-analysis of Prospective Studies

Clinical Orthopaedics and Related Research ◽

10.1097/corr.0000000000001225 ◽

2020 ◽

Vol 478 (6) ◽

pp. 1333-1344

Author(s):

Jesse W. P. Kuiper ◽

Steven J. Verberne ◽

Stan J. Vos ◽

Pim W. van Egmond

Keyword(s):

Systematic Review ◽

Prospective Studies ◽

Meta Analysis ◽

Elisa Test ◽

Lateral Flow ◽

Flow Test ◽

Lateral Flow Test ◽

Better Than

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Validation of the Reveal® 3-D for Peanut Lateral Flow Test: AOAC Performance Tested MethodSM 111901

Journal of AOAC International ◽

10.1093/jaoacint/qsz041 ◽

2020 ◽

Vol 103 (4) ◽

pp. 1112-1118

Author(s):

Quynh-Nhi Le ◽

Alexis Vance ◽

Nawal Bakir ◽

Dave Almy ◽

Emily Slenk ◽

...

Keyword(s):

Cross Reactivity ◽

Management Program ◽

Lateral Flow ◽

Ammonium Compound ◽

Flow Test ◽

Test Kit ◽

Low Levels ◽

Lateral Flow Test ◽

Food Commodities ◽

Assay Interference

Abstract Background Reveal® 3-D for Peanut is an immunochromatographic, lateral flow test for qualitative detection of peanut residue in food manufacturing and food preparation settings. The test can detect low ppm levels of peanut in clean-in-place (CIP) rinses and in swabs from environmental surfaces and can serve as a tool in managing allergen risk. Objective The objective of the study was to validate the lateral flow method for detection of peanut in CIP rinses, specifically water, peroxyacetic acid/hydrogen peroxide, and quaternary ammonium compound rinses, and in swabs taken from stainless steel and plastic surfaces. Methods CIP rinses spiked with low levels of peanut were tested, as were surfaces inoculated with peanut. Specificity and assay interference were assessed in testing of food commodities with and without added peanut. Assay robustness and test kit stability and consistency testing were also performed. Results Results demonstrated that the lateral flow test can detect peanut in CIP rinses in the range of 2–4 ppm and in environmental surface swabs in the range of 3–4 µg/100 cm2. Results of specificity testing with 29 common food items showed lack of cross-reactivity, and potential assay interference only from walnut. Data from stability trials supports expiration dating for the kit of up to 23 months post-manufacture. Conclusions and Highlights The lateral flow test is a sensitive, specific, and rapid method for detection of low levels of peanut residue in CIP rinses and environmental samples and can be an important component in a comprehensive allergen risk management program.

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Diagnostic Accuracy of Epithelial Membrane Antigen for Malignant Effusions: A Meta-Analysis

The International Journal of Biological Markers ◽

10.5301/jbm.5000181 ◽

2016 ◽

Vol 31 (1) ◽

pp. 11-16 ◽

Cited By ~ 1

Author(s):

Wentao Lin ◽

Xiaoxue Liu ◽

Ying Cen

Keyword(s):

Likelihood Ratio ◽

Sensitivity And Specificity ◽

Odds Ratio ◽

Epithelial Membrane Antigen ◽

Meta Analysis ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Diagnostic Odds Ratio ◽

Diagnostic Potential ◽

Malignant Effusions

Background and Objectives Body cavity fluid examination sometimes presents a diagnostic challenge in cytology practice. This meta-analysis was undertaken to comprehensively assess the diagnostic potential of epithelial membrane antigen (EMA) in malignant effusions. Materials and Methods All relevant original articles about EMA in the diagnosis of malignant effusions published up to July 1, 2014 were retrieved. The overall sensitivity, specificity, positive and negative likelihood ratio, diagnostic odds ratio, and summary receiver operating characteristic (SROC) curve were pooled to evaluate the diagnostic value of EMA for malignant effusions using the Meta-Disc 1.4 and STATA 12.0 statistical software. Results Eleven studies met the inclusion criteria for the meta-analysis and the summary estimates for EMA in the diagnosis of malignant effusions were as follows: sensitivity 0.9 (95% CI 0.83-0.87), specificity 0.87 (95% CI 0.96-0.99), positive likelihood ratio 5.8 (95% CI 15.59-36.37), negative likelihood ratio 0.15 (95% CI 0.07-0.20) and diagnostic odds ratio 52.63 (95% CI 20.91-132.49). The SROC curve indicated that the maximum joint sensitivity and specificity (Q-value) was 0.88; the area under the curve was 0.94. Conclusion The present meta-analysis indicated that EMA may be a useful diagnostic tool with good sensitivity and specificity for differentiating malignant effusions from benign effusions.

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Evaluation of a rapid lateral flow calprotectin test for the diagnosis of prosthetic joint infection

10.1101/19004473 ◽

2019 ◽

Author(s):

Alexander J. Trotter ◽

Rachael Dean ◽

Celia E. Whitehouse ◽

Jarle Mikalsen ◽

Claire Hill ◽

...

Keyword(s):

Synovial Fluid ◽

Sensitivity And Specificity ◽

Prosthetic Joint Infection ◽

Predictive Value ◽

Joint Infection ◽

Lateral Flow ◽

Lateral Flow Assay ◽

Prosthetic Joint ◽

Flow Test ◽

Lateral Flow Test

AbstractBackgroundMicrobiological diagnosis of prosthetic joint infection (PJI) relies on culture techniques that are slow and insensitive. Rapid tests are urgently required to improve patient management. Calprotectin is a neutrophil biomarker of inflammation that has been demonstrated to be effective for the diagnosis of PJI. A calprotectin based lateral flow test has been developed for the rapid detection of PJI using synovial fluid samples.MethodsA convenience series of 69 synovial fluid samples from patients at the Norfolk and Norwich University Hospitals (NNUH) were collected intraoperatively from 52 hip and 17 knee revision operations. Calprotectin levels were measured using a new commercially available lateral flow assay for PJI diagnosis (Lyfstone). For all samples, synovial fluid was pipetted onto the lateral flow device and the signal was read using a mobile phone app after 15 minutes incubation at room temperature.ResultsAccording to the Musculoskeletal Infection Society (MSIS) criteria, 24 patients were defined as PJI positive and the remaining 45 were negative. The overall accuracy of the lateral flow test against the MSIS criteria was 75%. The test had a sensitivity and specificity of 75% and 76% respectively with a positive predictive value (PPV) of 62% and a negative predictive value (NPV) of 85%. Discordant results were then reviewed by the clinical team using available patient data to develop an alternative gold standard for defining presence/absence of infection (MSIS+). Compared to MSIS+, the test showed an overall accuracy of 83%, sensitivity and specificity of 95% and 78% respectively, a PPV of 62% and an NPV of 98%. Test accuracy for hip revisions was 77% and for knee revisions was 100%.ConclusionsThis study demonstrates that the calprotectin lateral flow assay is an effective diagnostic test for PJI. Our data suggests that the test is likely to generate false positive results in patients with metallosis and gross osteolysis.

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Comparison of methods for the diagnosis of patent foramen ovale in patients with cryptogenic cerebral ischemia: a meta-analysis

10.22541/au.161626571.12319626/v1 ◽

2021 ◽

Author(s):

Xiaoxuan Guo ◽

Xiaojuan Wang ◽

Lu Zhang ◽

Yan Zhang ◽

Rui Peng ◽

...

Keyword(s):

Cerebral Ischemia ◽

Likelihood Ratio ◽

Sensitivity And Specificity ◽

Transthoracic Echocardiography ◽

Patent Foramen Ovale ◽

Meta Analysis ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Receiver Operating Curve ◽

Foramen Ovale

Background: Foramen ovale is a residual cavity in the developing heart in the fetus. At present, the standard methods for the diagnosis of PFO-right-to-left-shunting (PFO-RLS) include transesophageal echocardiography (TEE), contrast-transcranial Doppler echocardiography (C-TCD), and contrast-transthoracic echocardiography (C-TTE), each of them having its advantages and disadvantages.However, there are no data allowing the comparison of these three methods. Methods: We systematically reviewed all published studies on patients with cryptogenic cerebral ischemia. The sensitivity, specificity, and other indexes of C-TCD and C-TTE in the diagnosis of PFO-RLS were calculated using the Stata 16.0 software. The area under the summary receiver operating curve（SROC) was calculated. Results: Twenty-five 25 controlled studies involving a total of 2282 patients were analyzed. There was considerable heterogeneity between C-TCD and C-TTE sensitivity and specificity among the studies. The combined sensitivity and specificity of C-TCD and C-TTE were 0.95 (95%CI, 0.93-0.97) and 0.86(95%CI, 0.78-0.91), and 0.88 (95%CI, 0.69-0.96) and 0.99 (95%CI, 0.67-1.00). The positive likelihood ratio and negative likelihood ratio of C-TCD and C-TTE were 6.81 (95%CI, 4.42-10.48) and 0.05 (95%CI, 0.03-0.08), and 82.31(95%CI, 2.03-3341.00) and 0.12 (95%CI, 0.04-0.34). The areas under the SROC for C-TCD and C-TTE were 0.97 (95%CI, 0.95–0.98) and 0.98 (95%CI, 0.96–0.99), respectively, and were not significantly different by the Z test (z=-0.17, p=0.86). Conclusion: C-TCD and C-TTE have advantages in diagnosing PFO-RTL. The combination of C-TCD and C-TTE improves the detection rate and reduces the misdiagnosis rate. Key words: patent foramen ovale, cryptogenic cerebral ischemia, contrast-transthoracic echocardiography, contrast-transthoracic echocardiography

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Neutrophil-to-lymphocyte ratio predicts diagnosis and prognosis of patients with hepatocellular: A systematic review and meta-analysis

10.21203/rs.3.rs-26224/v1 ◽

2020 ◽

Author(s):

Shan Lin ◽

Shiping Hu ◽

Yun Ran ◽

Fenfang Wu

Keyword(s):

Likelihood Ratio ◽

Odds Ratio ◽

Meta Analysis ◽

Positive Likelihood Ratio ◽

Negative Likelihood Ratio ◽

Neutrophil To Lymphocyte Ratio ◽

Cochrane Library ◽

Summary Receiver Operating Characteristic ◽

Lymphocyte Ratio ◽

Meta Analyses

Abstract Background: Neutrophil-to-lymphocyte ratio (NLR) is one of the poor prognostic factors of Hepatocellular carcinoma (HCC) in patients. As contradictory data are seen concerning the predictive ability of NLR, a meta-analysis is performed for the determination of its prognostic value in patients with HCC in this study.Methods: We systematically searched several databases including PubMed, EMBASE, and Cochrane Library with the updated date of January 21, 2020. Pooled estimates of odds ratio (OR) and diagnostic odds ratio (DOR) were used to assess the prognostic performance of NLR in HCC patients.Results: Nine studies containing a total of 3,862 HCC patients were included. High baseline NLR was correlated with poor prognosis or recurrence significantly. The patient-based analysis of pooled estimates was as follows: sensitivity 0.68 [95% confidence interval (CI), 0.58-0.77], specificity 0.73 (95% CI, 0.61-0.82), and DOR 6.347 (95% CI, 5.450-7.391), respectively. The pooled positive likelihood ratio (PLR) and negative likelihood ratio (NLHR) were 2.5 (95% CI, 1.8-3.6) and 0.43 (95% CI, 0.33-0.57). Furthermore, the area under the curve (AUC) of summary receiver operating characteristic (SROC) reflecting the diagnostic accuracy was 0.76 (95% CI, 0.72-0.80). Results obtained from subgroup meta-analyses and overall meta-analyses were accordingly consistent with each other.Conclusions: Our findings suggested that NLR is an efficient prognostic factor for patients with HCC, especially for those from East Asian with high incidence. In the future, trails with larger sample sizes and more high-quality evidence are needed to further enhance the patient outcomes.

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Reveal Q+ MAX® for Detection of Total Af latoxin in Corn, Almonds, Pistachios, Walnuts, and Peanuts

Journal of AOAC International ◽

10.5740/jaoacint.18-0298 ◽

2019 ◽

Vol 102 (2) ◽

pp. 525-531 ◽

Cited By ~ 1

Author(s):

Quynh-Nhi Le ◽

Brooke Roman ◽

Dana Driksna ◽

Lindsey Gilbert ◽

Kaylee Gonzales ◽

...

Keyword(s):

Room Temperature ◽

Lateral Flow ◽

Immunochromatographic Test ◽

Total Aflatoxin ◽

Average Percentage ◽

Assay Performance ◽

Flow Test ◽

Test Kit ◽

Lateral Flow Test ◽

Stability Results

Abstract Background: The Reveal Q+ MAX for Aflatoxin is a lateral flow immunochromatographic test intended for quantitative analysis within 6 min after aqueous extraction. Objective: Work was conducted to validate the performance of the Reveal Q+ MAX for Aflatoxin method in selected corn and nut matrixes. Methods: This method was validated under the requirements of the AOAC Research Institute Performance Tested MethodSM program. Fivematrixes, including corn naturally contaminated with aflatoxin at 0, 5.2, 21.0, 51.6, 103.6, and 282 ppb as well as peanuts, pistachios, walnuts, and almonds spiked at 0, 5, 20, 50, and 300 ppb were analyzed. Results: Average percentage recoveries of the added aflatoxin from the matrixes ranged from 80.8 to 116.9%. Average LOD for all matrixes is 2 ppb and LOQ is 7 ppb. With the exceptionof sample size for almonds, robustness trials demonstrated that deliberate changes to the assay parameters minimally affected the Reveal Q+ MAX assay performance. Finally, stability results from three independently manufactured lots support Reveal Q+ MAX for Aflatoxin performance consistency and shelf-life of 18 months when stored at room temperature. Conclusions: This study appropriatelyvalidates the Performance Tested MethodSM claim forcorn and selected nut matrixes on Reveal Q+ MAX forAflatoxin, an aqueous lateral flow test kit. Highlights: Aqueous lateral flow test kit detects total aflatoxin between 80 to 120% yieldwith an LOD of 2 ppb.

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