Standards For Reporting Of Diagnostic Accuracy Studies Research Articles

Systematic Review and STARD Scoring of Renal Cell Carcinoma Circulating Diagnostic Biomarker Manuscripts.

BackgroundNo validated molecular biomarkers exist to help guide diagnosis of renal cell carcinoma (RCC) patients. We seek to evaluate the quality of published RCC circulating diagnostic biomarker manuscripts using the Standards for Reporting of Diagnostic Accuracy Studies (STARD) guidelines.MethodsThe phrase “(renal cell carcinoma OR renal cancer OR kidney cancer OR kidney carcinoma) AND circulating AND (biomarkers OR cell free DNA OR tumor DNA OR methylated cell free DNA OR methylated tumor DNA)” was searched in Embase, MEDLINE, and PubMed in March 2018. Relevant manuscripts were scored using 41 STARD subcriteria for a maximal score of 26 points. All tests of statistical significance were 2 sided.ResultsThe search identified 535 publications: 27 manuscripts of primary research were analyzed. The median STARD score was 11.5 (range = 7-16.75). All manuscripts had appropriate abstracts, introductions, and distribution of alternative diagnoses. None of the manuscripts stated how indeterminant data were handled or if adverse events occurred from performing the index test or reference standard. Statistically significantly higher STARD scores were present in manuscripts reporting receiver operator characteristic curves (P < .001), larger sample sizes (P = .007), and after release of the original STARD statement (P = .005).ConclusionsMost RCC circulating diagnostic biomarker manuscripts poorly adhere to the STARD guidelines. Future studies adhering to STARD guidelines may address this unmet need.

Reporting Quality of Diagnostic Accuracy Studies in Laboratory Medicine: Adherence to Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015.

BackgroundPoor reporting quality in diagnostic accuracy studies hampers an adequate judgment of the validity of the study. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was published to improve the reporting quality of diagnostic accuracy studies. This study aimed to evaluate the adherence of diagnostic accuracy studies published in Annals of Laboratory Medicine (ALM) to STARD 2015 and to identify directions for improvement in the reporting quality of these studies.MethodsTwo independent authors assessed articles published in ALM between 2012–2018 for compliance with 30 STARD 2015 checklist items to identify all eligible diagnostic accuracy studies published during this period. We included 66 diagnostic accuracy studies. A total of the fulfilled STARD items were calculated, and adherence was analyzed on an individual-item basis.ResultsThe overall mean±SD number of STARD items reported for the included studies was 11.2±2.7. Only five (7.6%) studies adhered to more than 50% of the 30 items. No study satisfied more than 80% of the items. Large variability in adherence to reporting standards was detected across items, ranging from 0% to 100%.ConclusionsAdherence to STARD 2015 is suboptimal among diagnostic accuracy studies published in ALM. Our study emphasizes the necessity of adherence to STARD to improve the reporting quality of future diagnostic accuracy studies to be published in ALM.

Detecting Hydroxychloroquine Retinal Toxicity using a Novel Multifocal Electroretinography Stimulus

AbstractPurposeTo evaluate a novel 5‐ring multifocal electroretinogram (mfERG) stimulus as a screening test for detecting hydroxychloroquine (HCQ) retinopathy.Study DesignA stratified case‐control study conducted in accordance to the Standards for Reporting of Diagnostic Accuracy Studies (STARD).MethodsConsecutive patients referred to the University of Ottawa for HCQ retinopathy screening from July 2018 to September 2018 underwent testing using a novel 5‐ring mfERG stimulus and the standard 61‐hexagon mfERG stimulus. Patients with amblyopia, high myopia or hyperopia, coexisting retinal disease, and prior retinal surgery were excluded. mfERG parameters were compared between protocols and against cumulative dose (CD), dose by real body weight (RBW), and duration of HCQ therapy. Ring amplitudes (R1‐R5) and ring ratios (R1‐R4/R5) were collected for each stimulus protocol. mfERG data was collected from an additional group of controls with no previous exposure to HCQ. Stata 15.1 software was used to perform the regression analyses, and to compute Spearman correlation coefficients between variables.Results24 eyes (10 patients, 2 controls) were included in the final analysis. The novel R2 and R3 P1 amplitudes and R2/R5 were moderately correlated with the respective R2 (r = 0.434, p = 0.034) and R3 (r = 0.429, p = 0.036) P1 amplitudes and R2/R5 (r = 0.422, p = 0.040) of the 61‐hexagon stimulus. The novel R2 P1 amplitude was highly correlated with CD (r = −0.687, p &lt; 0.001), treatment duration (r = −0.687, p &lt; 0.001), and dose by RBW (r = −0.763, p &lt; 0.001). Similarly, novel R2/R5 was highly correlated with CD (r = −0.743, p &lt; 0.001), treatment duration (r = −0.743, p &lt; 0.001), and dose by RBW (r = −0.567, p = 0.004). The correlations between the 61‐hexagon stimulus R2/R5 and HCQ risk factors also reached significance but were not as robust. Linear regression analysis showed that CD may account for almost half of the variance in the novel R2/R5. (r2 = 0.486, R2/R5 = 9.68063 + cumulative dose ‐0.00286)ConclusionsThe 2016 AAO guidelines focused primarily on the use of subjective functional testing and objective structural testing and relegated mfERG based on a lack of accessibility. This pilot study describes a new 5‐ring mfERG protocol specific for HCQ retinopathy screening and suggests equivalence to the 61‐hexagon protocol at characterizing parafoveal function. This novel 5‐ring stimulus has a significantly shorter acquisition period and the ring design may be more sensitive to HCQ induced electrophysiologic change in the parafoveal region. R2 P1 amplitude and R2/R5 ring ratios acquired using this novel mfERG stimulus are strongly correlated to treatment duration and HCQ dosing. Additional prospective cohort studies are needed to validate this novel stimulus which may decrease the resource burden associated with objective functional testing.

Adequate Reporting of Dental Diagnostic Accuracy Studies is Lacking: An Assessment of Reporting in Relation to the Standards for Reporting of Diagnostic Accuracy Studies Statement

ObjectiveThe objective of this study was to assess the quality of reporting of full-text articles of dental diagnostic accuracy studies published in eight leading speciality dental journals in relation to the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement. MethodsThe full articles of all included studies were assessed for their adherence to the 30-item STARD checklist by two researchers independently. A score of 0-2 was attributed to each item. Inter-rater agreement was assessed. Univariate and multivariate linear regression analyses were carried out to evaluate differences in reporting qualities between journals and whether certain variables influenced reporting qualities. ResultsA total of 145 articles were identified. Full-article STARD checklist items relating to methodology and results were poorly reported. The overall mean quality score for full articles was 28.75. Articles published in the Journal of Cranio-Maxillofacial Surgery obtained the highest quality score. In the multivariate analysis, articles published in the Journal of Cranio-Maxillofacial Surgery had significantly higher reporting quality scores than those published in the European Journal of Orthodontics (β = −6.97, 95% confidence interval [CI]: −11.62, −2.30, P < .05), the Journal of Prosthetic Dentistry (β = −8.01, 95% CI: −14.60, −1.41, P < .05) and Oral Diseases (β = −6.72, 95% CI: −11.57, −1.86, P < .05). Reporting quality improved each year (P < .028). ConclusionAdherence of full articles to the STARD is suboptimal in dental journals.

Outcome Measures for Baro-Challenge-Induced Eustachian Tube Dysfunction: A Systematic Review.

Baro-challenge-induced Eustachian tube dysfunction (baro-induced ETD) is characterized by failure of the Eustachian tube (ET) to open adequately to permit middle-ear pressure regulation during ambient pressure changes. There are no well-characterized tests for identifying the condition, which makes both patient diagnosis and research into treatment efficacy challenging. This systematic review evaluates ET function tests as potential outcome measures for baro-induced ETD. MEDLINE and CENTRAL were searched (database inception to March 2017) and reference lists reviewed for all relevant English Language articles. Tests in included studies were required to measure ET function in patients reporting baro-induced ear symptoms or barotrauma. Data were extracted in a standardized manner, and studies assessed according to Standards for Reporting of Diagnostic Accuracy Studies (STARD) criteria. The primary outcome of interest was the accuracy of ET function tests. Heterogeneity of subject demographics, ET function test methodology, and reference standards only permitted narrative systematic review. Sixteen studies involving seven different types of ET function tests were identified. The nine-step test was the most commonly used outcome measure, with overall test sensitivity and specificity ranges of 37 to 100% and 57 to 100%, respectively. Tympanometry test sensitivity was consistently poor (0-50%) while specificity was higher (52-97%). Published accuracy data for other ET function tests and test combinations were limited. Currently, no single test can be recommended for use in clinical practice. A combination of the nine-step test with other objective tests or patient-reported measures appears most promising as a core set of outcome measures for baro-induced ETD.

Diagnostic accuracy research in glaucoma is still incompletely reported: An application of Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015.

BackgroundResearch has shown a modest adherence of diagnostic test accuracy (DTA) studies in glaucoma to the Standards for Reporting of Diagnostic Accuracy Studies (STARD). We have applied the updated 30-item STARD 2015 checklist to a set of studies included in a Cochrane DTA systematic review of imaging tools for diagnosing manifest glaucoma.MethodsThree pairs of reviewers, including one senior reviewer who assessed all studies, independently checked the adherence of each study to STARD 2015. Adherence was analyzed on an individual-item basis. Logistic regression was used to evaluate the effect of publication year and impact factor on adherence.ResultsWe included 106 DTA studies, published between 2003–2014 in journals with a median impact factor of 2.6. Overall adherence was 54.1% for 3,286 individual rating across 31 items, with a mean of 16.8 (SD: 3.1; range 8–23) items per study. Large variability in adherence to reporting standards was detected across individual STARD 2015 items, ranging from 0 to 100%. Nine items (1: identification as diagnostic accuracy study in title/abstract; 6: eligibility criteria; 10: index test (a) and reference standard (b) definition; 12: cut-off definitions for index test (a) and reference standard (b); 14: estimation of diagnostic accuracy measures; 21a: severity spectrum of diseased; 23: cross-tabulation of the index and reference standard results) were adequately reported in more than 90% of the studies. Conversely, 10 items (3: scientific and clinical background of the index test; 11: rationale for the reference standard; 13b: blinding of index test results; 17: analyses of variability; 18; sample size calculation; 19: study flow diagram; 20: baseline characteristics of participants; 28: registration number and registry; 29: availability of study protocol; 30: sources of funding) were adequately reported in less than 30% of the studies. Only four items showed a statistically significant improvement over time: missing data (16), baseline characteristics of participants (20), estimates of diagnostic accuracy (24) and sources of funding (30).ConclusionsAdherence to STARD 2015 among DTA studies in glaucoma research is incomplete, and only modestly increasing over time.

Reporting of imaging diagnostic accuracy studies with focus on MRI subgroup: Adherence to STARD 2015.

To evaluate adherence of diagnostic accuracy studies in imaging journals to the STAndards for Reporting of Diagnostic accuracy studies (STARD) 2015. The secondary objective was to identify differences in reporting for magnetic resonance imaging (MRI) studies. MEDLINE was searched for diagnostic accuracy studies published in imaging journals in 2016. Studies were evaluated for adherence to STARD 2015 (30 items, including expanded imaging specific subitems). Evaluation for differences in STARD adherence based on modality, impact factor, journal STARD adoption, country, subspecialty area, study design, and journal was performed. Adherence (n = 142 studies) was 55% (16.6/30 items, SD = 2.2). Index test description (including imaging-specific subitems) and interpretation were frequently reported (>66% of studies); no important differences in reporting of individual items were identified for studies on MRI. Infrequently reported items (<33% of studies) included some critical to generalizability (study setting and location) and assessment of bias (blinding of assessor of reference standard). New STARD 2015 items: sample size calculation, protocol reporting, and registration were infrequently reported. Higher impact factor (IF) journals reported more items than lower IF journals (17.2 vs. 16 items; P = 0.001). STARD adopter journals reported more items than nonadopters (17.5 vs. 16.4 items; P = 0.01). Adherence varied between journals (P = 0.003). No variability for study design (P = 0.32), subspecialty area (P = 0.75), country (P = 0.28), or imaging modality (P = 0.80) was identified. Imaging accuracy studies show moderate adherence to STARD 2015, with only minor differences for studies evaluating MRI. This baseline evaluation will guide targeted interventions towards identified deficiencies and help track progress in reporting. 1 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2018;47:523-544.

STARD guidelines: another piece of an intricate puzzle for evaluating the quality of scientific publishing.

This focused issue of Annals of Translational Medicine supplies a comprehensive debate about the 2015 Standards for Reporting of Diagnostic Accuracy Studies (STARD) guidelines. The editors of some authoritative journals provide their personal contribution to the topic, reviewing the many pros and the still remaining gaps about the publication of high quality diagnostic studies. As the Guest Editor of this issue, I would try to give simple keys of lecture that might help illustrate the substantial contribution emerging from the new 2015 STARD guideline, but also some crucial questions remaining unanswered.

Does the Reporting Quality of Diagnostic Test Accuracy Studies, as Defined by STARD 2015, Affect Citation?

ObjectiveTo determine the rate with which diagnostic test accuracy studies that are published in a general radiology journal adhere to the Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015, and to explore the relationship between adherence rate and citation rate while avoiding confounding by journal factors.Materials and MethodsAll eligible diagnostic test accuracy studies that were published in the Korean Journal of Radiology in 2011–2015 were identified. Five reviewers assessed each article for yes/no compliance with 27 of the 30 STARD 2015 checklist items (items 28, 29, and 30 were excluded). The total STARD score (number of fulfilled STARD items) was calculated. The score of the 15 STARD items that related directly to the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 was also calculated. The number of times each article was cited (as indicated by the Web of Science) after publication until March 2016 and the article exposure time (time in months between publication and March 2016) were extracted.ResultsSixty-three articles were analyzed. The mean (range) total and QUADAS-2-related STARD scores were 20.0 (14.5–25) and 11.4 (7–15), respectively. The mean citation number was 4 (0–21). Citation number did not associate significantly with either STARD score after accounting for exposure time (total score: correlation coefficient = 0.154, p = 0.232; QUADAS-2-related score: correlation coefficient = 0.143, p = 0.266).ConclusionThe degree of adherence to STARD 2015 was moderate for this journal, indicating that there is room for improvement. When adjusted for exposure time, the degree of adherence did not affect the citation rate.

STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies.

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies.

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

An extension of STARD statements for reporting diagnostic accuracy studies on liver fibrosis tests: The Liver-FibroSTARD standards

Chronic liver diseases are highly prevalent and require an accurate evaluation of liver fibrosis to determine patient management. Over the last decade, great effort has been made to develop non-invasive liver fibrosis tests. The ensuing increase of literature is, however, impaired by extensive heterogeneity in the quality of published reports. The Standards for Reporting of Diagnostic Accuracy Studies (STARD), first published in 2003, were developed to improve the quality of research reports on diagnostic studies. We aimed to evaluate STARD statements in the setting of diagnostic studies on non-invasive liver fibrosis tests, and to propose an extended version developed specifically for those studies. Eight French experts evaluated STARD statement adequacy in 10 studies on non-invasive liver fibrosis tests and then developed an extended version with a glossary. The new checklist and glossary were independently evaluated by seven international experts. Fourteen of the 25 STARD items were considered only partially adequate for the evaluation of diagnostic studies on non-invasive liver fibrosis tests. Inter-expert agreement was at least very good for 8 STARD items (32%), moderate for 9 (36%), and poor or very poor for 8 (32%). The experts' proposals were developed into the new Liver-FibroSTARD standards including a checklist with 62 items/sub-items and a corresponding comprehensive glossary. New proposals were inserted in the 25 STARD items as a complementary module. Independent evaluation of the Liver-FibroSTARD checklist showed at least very good inter-expert agreement for 39 items/sub-items (63%), moderate agreement for 11 (18%), and poor or very poor agreement for only 12 (19%). As a supplement of the STARD statements, the Liver-FibroSTARD checklist and its glossary are new tools specifically designed for the evaluation of diagnostic studies about non-invasive liver fibrosis tests.

Protocol for Accuracy of Point of Care (POC) or In-Office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)

Background: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing. Study Design: A diagnostic accuracy study of urine drug testing. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objective: To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample. Methods: The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized. Results: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated. Limitations: The limitations include lack of availability of POC testing with lower cutoff levels. Conclusion: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics. Clinical Trial Registration: NCT 01052155 Key words: Controlled substances, opioids, benzodiazepines, illicit drugs, abuse, diversion, adherence monitoring, prescription monitoring programs

Sensitivity and Specificity: A Review of Related Statistics and Controversies in the Context of Physical Therapist Education

Background and Purpose. Sensitivity and specificity are important factors to consider when evaluating the validity of a diagnostic test. The 2 measures can help to determine whether test results are indicative of the actual disease status during client assessment and evaluation. Their properties, however, can be misinterpreted in clinical settings. The purpose of this paper is three-fold: (1) to review the appropriate interpretation of sensitivity and specificity, positive and negative predictive values, likelihood ratios, posttest probabilities, and receiver operating characteristic (ROC) curves; (2) to discuss limitations of sensitivity and specificity as sole indicators of test validity; and (3) to offer recommendations for educators to improve related curricular content. Position and Rationale. The position adopted in this paper is that physical therapist education programs should cover the concepts of sensitivity and specificity in depth and in combination with other elements of test characteristics prior to discussing specific clinical tests and their applications to clinical decision making. Related content should include a review of the appropriate interpretation of sensitivity and specificity as well as an introduction to positive and negative predictive values, likelihood ratios, posttest probabilities, and ROC curves. The limitations of sensitivity and specificity as sole indicators of test validity should also be discussed. The rationale for this approach is based on the potential over-reliance of students and educators on sensitivity and specificity alone to establish the validity of clinical measures. Conclusion and Recommendations. Sensitivity and specificity will continue to be very important concepts in physical therapist education. Educators, however, should thoroughly discuss sensitivity and specificity prior to using them across the curriculum and emphasize limitations of these test properties in clinical diagnostic practice. Specific recommendations include a review of the 2 x 2 table, evaluation of specific studies on diagnostic tests, using related measures to evaluate validity, class exercises using interval estimates, and a review of the Standards for Reporting of Diagnostic Accuracy Studies (STARD) and Quality Assessment of Diagnostic Accuracy Studies (QUADAS) initiatives for research on diagnostic test validity. Key Words: Sensitivity, Specificity, Likelihood ratios, Predictive values. BACKGROUND AND PURPOSE Evidence-based practice (EBP) is an integral part of the Vision 2020 Statement of the American Physical Therapy Association (APTA).1,2 One vital component of EBP is the use of valid diagnostic tests. Sensitivity and specificity are important components of validity, providing estimates of the extent to which test results match the actual disease status. To assure that physical therapist (PT) students make grounded decisions in the test selection and application process, measurement validity, and the related concepts of sensitivity and specificity, should be introduced early in the curriculum. The inclusion of sensitivity and specificity estimates in commonly used physical therapy textbooks are evidence of this issue's increasing importance.3-5 Students are typically taught to apply these concepts in choosing a diagnostic test. Increasingly however, students must also learn to apply these concepts in treatment selection. Sensitivity and specificity can be used to help determine responses to interventions using clinical prediction rules or other criteria. In spite of the relevance of sensitivity and specificity to clinical practice, recent studies suggest that a large proportion of physicians lack adequate knowledge of these test properties.6,7 Reid et al,6 in a survey of 300 practicing physicians, reported that only 58% used sensitivity and specificity in the interpretation of test results, and just 5% of those interpreted them in the recommended manner. …

Meta-Analysis for the Pooled Sensitivity and Specificity of anti-Human Immunodeficiency Virus Ab Rapid Tests

Many immunochromatography (ICA) kits for anti-human immunodeficiency virus type (HIV) antibody (Ab) have been introduced to improve the accessibility of HIV Ab tests. However, qualified evaluation reports for HIV rapid tests are not enough to validate their performances. Meta-analysis for the performances of the HIV Ab rapid tests was performed in this study. PubMed database was searched with combination of search terms, 'human immunodeficiency virus', 'HIV Ab', 'rapid test', 'immunochromatography', 'performance', 'sensitivity', and 'specificity'. Criteria of inclusion were performance studies for HIV ICA kits with serum or EDTA whole blood. Methodological qualities were evaluated with standards for reporting of diagnostic accuracy studies (STARD) checklists by two investigators. Homogeneity among selected studies was evaluated and then pooled sensitivity and specificity were calculated. Positive and negative predictive values were simulated with presumed HIV prevalence in Korea. Twenty-three studies were selected from 12 high-qualified papers with STARD checklists. The performance of 23 studies were found to be heterogeneous (P<0.1) and random effect model was used. Pooled sensitivity was 99.71% (95% CI: 99.45-99.97%) and pooled specificity was 99.27% (95% CI: 98.83-99.70%). With HIV prevalence of 0.03%, positive and negative predictive values were presumed to be 3.936% and 99.999%, respectively. This meta-analysis for HIV ICA rapid tests showed good performance. In consideration of low positive predictive values of HIV rapid tests, confirmation by enzyme immunoassay or Western blot is still needed. This study would be helpful in evaluating and establishing proper performance guideline for those kits not fully evaluated.

Meta-Analysis for the Pooled Sensitivity and Specificity of Hepatitis B Surface Antigen Rapid Tests

Although hepatitis B surface antigen (HBsAg) rapid test based on immunochromatographic assay (ICA) is now widely used, the test has not been evaluated sufficiently enough to validate its performance. Thus, it is important to summarize the clinical performance of the test kits. In this study, we performed meta-analysis for the performance of the HBsAg rapid tests. PubMed database was searched using keywords about the accuracy of diagnostic tests for hepatitis B virus (HBV) infection. Two investigators assessed methodological quality utilizing standards for reporting of diagnostic accuracy studies (STARD) checklist. After performing a heterogeneity test, we obtained pooled sensitivity and specificity. Positive and negative predictive values (PPV and NPV) were simulated according to HBV prevalence. A total of 38 studies was selected from 10 papers. The quality scores ranged from 3 to 13 (median, 8). Kappa value was good (0.85). The performance of the 38 studies was heterogeneous. When 33 studies with better quality from 7 papers were re-selected, the pooled sensitivity and specificity were 98.07% (95% confidence interval, CI: 97.67-98.47%) and 99.56% (95% CI: 99.21-99.91%), respectively. With an HBV prevalence of 5%, PPV and NPV were predicted to be 92.14% and 99.90%, respectively. In view of high HBV prevalence in Korea, it is thought that the HBsAg rapid test can be used for HBV screening in small-sized laboratories or for epidemiologic studies. This study should be helpful in establishing a guideline for the proper performance evaluation of the HBsAg rapid tests.

Quality Evaluation of the Performance Study of Diagnostic Tests Using STARD Checklist andMeta-Analysis for the Pooled Sensitivity and Specificity of Third Generation Anti-HCV EIA Tests

The third generation anti-hepatitis C virus (HCV) enzyme immunoassay (EIA) is now in use for screening HCV infection. The aim of this study was to pool the data on the sensitivity and specificity of third generation anti-HCV EIA tests after evaluating the quality of the studies using Standards for Reporting of Diagnostic Accuracy studies (STARD) checklist. We searched MEDLINE and PubMed databases using keywords about the accuracy of diagnostic tests for HCV infections. Methodological quality was assessed by two persons with a modified STARD checklist. A heterogeneity test was performed, and in case heterogeneity was present, a sub-group analysis was done. Fixed-effects model was used to obtain pool sensitivity and specificity with 95% confidence intervals (CI). A total of 41 studies from 16 papers were selected. The quality score ranged from 6 to 13 (median 10.5); Inter-observer agreement was 93.62% (k=0.69); and 41 studies revealed heterogeneity. We performed a sub-group analysis with only 28 studies from 13 papers that were evaluated to be of high quality. A subgroup using polymerase chain reaction as the reference test revealed homogeneity and was calculated the pooled sensitivity and specificity of 99.92% (CI 99.77-100.07%) and 99.66% (CI 99.45-99.86%) respectively. Studies on test kits with an increased reactivity to the core region also showed homogeneity in sensitivity and the pooled sensitivity was 99.78% (CI 99.53-100.03%). For the first time in Korea, the diagnostic accuracy of test kits was evaluated by meta-analysis using STARD checklist. The methodology shown in this study should help extending laboratory medicine to an evidence-based medicine.