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The Cochrane Database of Systematic... Jun 2020The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and resulting COVID-19 pandemic present important diagnostic challenges. Several diagnostic...
BACKGROUND
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and resulting COVID-19 pandemic present important diagnostic challenges. Several diagnostic strategies are available to identify current infection, rule out infection, identify people in need of care escalation, or to test for past infection and immune response. Serology tests to detect the presence of antibodies to SARS-CoV-2 aim to identify previous SARS-CoV-2 infection, and may help to confirm the presence of current infection.
OBJECTIVES
To assess the diagnostic accuracy of antibody tests to determine if a person presenting in the community or in primary or secondary care has SARS-CoV-2 infection, or has previously had SARS-CoV-2 infection, and the accuracy of antibody tests for use in seroprevalence surveys.
SEARCH METHODS
We undertook electronic searches in the Cochrane COVID-19 Study Register and the COVID-19 Living Evidence Database from the University of Bern, which is updated daily with published articles from PubMed and Embase and with preprints from medRxiv and bioRxiv. In addition, we checked repositories of COVID-19 publications. We did not apply any language restrictions. We conducted searches for this review iteration up to 27 April 2020.
SELECTION CRITERIA
We included test accuracy studies of any design that evaluated antibody tests (including enzyme-linked immunosorbent assays, chemiluminescence immunoassays, and lateral flow assays) in people suspected of current or previous SARS-CoV-2 infection, or where tests were used to screen for infection. We also included studies of people either known to have, or not to have SARS-CoV-2 infection. We included all reference standards to define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction tests (RT-PCR) and clinical diagnostic criteria).
DATA COLLECTION AND ANALYSIS
We assessed possible bias and applicability of the studies using the QUADAS-2 tool. We extracted 2x2 contingency table data and present sensitivity and specificity for each antibody (or combination of antibodies) using paired forest plots. We pooled data using random-effects logistic regression where appropriate, stratifying by time since post-symptom onset. We tabulated available data by test manufacturer. We have presented uncertainty in estimates of sensitivity and specificity using 95% confidence intervals (CIs).
MAIN RESULTS
We included 57 publications reporting on a total of 54 study cohorts with 15,976 samples, of which 8526 were from cases of SARS-CoV-2 infection. Studies were conducted in Asia (n = 38), Europe (n = 15), and the USA and China (n = 1). We identified data from 25 commercial tests and numerous in-house assays, a small fraction of the 279 antibody assays listed by the Foundation for Innovative Diagnostics. More than half (n = 28) of the studies included were only available as preprints. We had concerns about risk of bias and applicability. Common issues were use of multi-group designs (n = 29), inclusion of only COVID-19 cases (n = 19), lack of blinding of the index test (n = 49) and reference standard (n = 29), differential verification (n = 22), and the lack of clarity about participant numbers, characteristics and study exclusions (n = 47). Most studies (n = 44) only included people hospitalised due to suspected or confirmed COVID-19 infection. There were no studies exclusively in asymptomatic participants. Two-thirds of the studies (n = 33) defined COVID-19 cases based on RT-PCR results alone, ignoring the potential for false-negative RT-PCR results. We observed evidence of selective publication of study findings through omission of the identity of tests (n = 5). We observed substantial heterogeneity in sensitivities of IgA, IgM and IgG antibodies, or combinations thereof, for results aggregated across different time periods post-symptom onset (range 0% to 100% for all target antibodies). We thus based the main results of the review on the 38 studies that stratified results by time since symptom onset. The numbers of individuals contributing data within each study each week are small and are usually not based on tracking the same groups of patients over time. Pooled results for IgG, IgM, IgA, total antibodies and IgG/IgM all showed low sensitivity during the first week since onset of symptoms (all less than 30.1%), rising in the second week and reaching their highest values in the third week. The combination of IgG/IgM had a sensitivity of 30.1% (95% CI 21.4 to 40.7) for 1 to 7 days, 72.2% (95% CI 63.5 to 79.5) for 8 to 14 days, 91.4% (95% CI 87.0 to 94.4) for 15 to 21 days. Estimates of accuracy beyond three weeks are based on smaller sample sizes and fewer studies. For 21 to 35 days, pooled sensitivities for IgG/IgM were 96.0% (95% CI 90.6 to 98.3). There are insufficient studies to estimate sensitivity of tests beyond 35 days post-symptom onset. Summary specificities (provided in 35 studies) exceeded 98% for all target antibodies with confidence intervals no more than 2 percentage points wide. False-positive results were more common where COVID-19 had been suspected and ruled out, but numbers were small and the difference was within the range expected by chance. Assuming a prevalence of 50%, a value considered possible in healthcare workers who have suffered respiratory symptoms, we would anticipate that 43 (28 to 65) would be missed and 7 (3 to 14) would be falsely positive in 1000 people undergoing IgG/IgM testing at days 15 to 21 post-symptom onset. At a prevalence of 20%, a likely value in surveys in high-risk settings, 17 (11 to 26) would be missed per 1000 people tested and 10 (5 to 22) would be falsely positive. At a lower prevalence of 5%, a likely value in national surveys, 4 (3 to 7) would be missed per 1000 tested, and 12 (6 to 27) would be falsely positive. Analyses showed small differences in sensitivity between assay type, but methodological concerns and sparse data prevent comparisons between test brands.
AUTHORS' CONCLUSIONS
The sensitivity of antibody tests is too low in the first week since symptom onset to have a primary role for the diagnosis of COVID-19, but they may still have a role complementing other testing in individuals presenting later, when RT-PCR tests are negative, or are not done. Antibody tests are likely to have a useful role for detecting previous SARS-CoV-2 infection if used 15 or more days after the onset of symptoms. However, the duration of antibody rises is currently unknown, and we found very little data beyond 35 days post-symptom onset. We are therefore uncertain about the utility of these tests for seroprevalence surveys for public health management purposes. Concerns about high risk of bias and applicability make it likely that the accuracy of tests when used in clinical care will be lower than reported in the included studies. Sensitivity has mainly been evaluated in hospitalised patients, so it is unclear whether the tests are able to detect lower antibody levels likely seen with milder and asymptomatic COVID-19 disease. The design, execution and reporting of studies of the accuracy of COVID-19 tests requires considerable improvement. Studies must report data on sensitivity disaggregated by time since onset of symptoms. COVID-19-positive cases who are RT-PCR-negative should be included as well as those confirmed RT-PCR, in accordance with the World Health Organization (WHO) and China National Health Commission of the People's Republic of China (CDC) case definitions. We were only able to obtain data from a small proportion of available tests, and action is needed to ensure that all results of test evaluations are available in the public domain to prevent selective reporting. This is a fast-moving field and we plan ongoing updates of this living systematic review.
Topics: Antibodies, Viral; Antibody Specificity; Betacoronavirus; COVID-19; Coronavirus Infections; False Negative Reactions; False Positive Reactions; Humans; Immunoglobulin A; Immunoglobulin G; Immunoglobulin M; Pandemics; Pneumonia, Viral; Reference Standards; Reverse Transcriptase Polymerase Chain Reaction; SARS-CoV-2; Selection Bias; Sensitivity and Specificity; Serologic Tests
PubMed: 32584464
DOI: 10.1002/14651858.CD013652 -
Clinical Infectious Diseases : An... Jun 2020We conducted a systematic review of relevant syphilis diagnostic literature to address the question, "What is the sensitivity and specificity of the treponemal tests...
We conducted a systematic review of relevant syphilis diagnostic literature to address the question, "What is the sensitivity and specificity of the treponemal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of syphilis (by stage)?" There were 16 treponemal assays evaluated: 13 immunoassays and 3 manual assays (fluorescent treponemal antibody absorbed test [FTA-ABS], microhemagglutination assay for Treponema pallidum antibodies [MHA-TP], Treponema pallidum particle agglutination assay [TP-PA]). MHA-TP and FTA-ABS were less sensitive in primary and secondary syphilis than TP-PA; TP-PA is the most specific manual treponemal assay. There is insufficient evidence to recommend one particular treponemal immunoassay (eg, enzyme immunoassays, chemiluminescence immunoassays, microbead immunoassays) over another based on published performance data. For diagnosis of neurosyphilis, cerebrospinal fluid (CSF) TP-PA has similar performance to CSF FTA-ABS in studies with patients with definitive or presumptive neurosyphilis. However, CSF treponemal testing has limitations in its sensitivity and specificity and should be interpreted within the context of the clinical scenario, additional CSF test results and syphilis prevalence.
Topics: Antibodies, Bacterial; Humans; Neurosyphilis; Sensitivity and Specificity; Syphilis; Syphilis Serodiagnosis; Treponema pallidum
PubMed: 32578866
DOI: 10.1093/cid/ciaa349 -
Clinical Infectious Diseases : An... Jun 2020We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, "What is the sensitivity and specificity of the Syphilis... (Meta-Analysis)
Meta-Analysis
We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, "What is the sensitivity and specificity of the Syphilis Health Check, a rapid qualitative test for the detection of human antibodies to Treponema pallidum." The Syphilis Health Check is the only rapid syphilis test currently cleared by the Food and Drug Administration (FDA). We conducted a systematic review and a meta-analysis using Bayesian bivariate random-effects and fixed-effect models to create pooled estimates of sensitivity and specificity of the Syphilis Health Check. We identified 5 test evaluations published in the literature and 10 studies submitted to the FDA and for a Clinical Laboratory Improvement Amendments waiver application. The pooled sensitivity (95% CI) from the laboratory evaluations (n = 5) was 98.5% (92.1-100%), while pooled specificity was 95.9% (81.5-100.0%). The pooled sensitivity for prospective studies (n = 10) was 87.7% ( 71.8-97.2%), while pooled specificity was 96.7% (91.9-99.2%). Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8-98.6%). The Syphilis Health Check may provide accurate detection of treponemal antibody.
Topics: Antibodies, Bacterial; Bayes Theorem; Humans; Point-of-Care Systems; Prospective Studies; Sensitivity and Specificity; Syphilis; Syphilis Serodiagnosis; Treponema pallidum
PubMed: 32578863
DOI: 10.1093/cid/ciaa350 -
PLoS Neglected Tropical Diseases May 2020Due to the success of the Global Programme to Eliminate Lymphatic Filariasis (GPELF) many countries have either eliminated the disease as a public health problem or are...
Due to the success of the Global Programme to Eliminate Lymphatic Filariasis (GPELF) many countries have either eliminated the disease as a public health problem or are scheduled to achieve this elimination status in the coming years. The World Health Organization (WHO) recommend that the Transmission Assessment Survey (TAS) is used routinely for post-mass drug administration (MDA) surveillance but it is considered to lack sensitivity in low prevalence settings and not be suitable for post-validation surveillance. Currently there is limited evidence to support programme managers on the design of appropriate alternative strategies to TAS that can be used for post-validation surveillance, as recommended by the WHO. We searched for human and mosquito LF surveillance studies conducted between January 2000 and December 2018 in countries which had either completed MDA or had been validated as having eliminated LF. Article screening and selection were independently conducted. 44 papers met the eligibility criteria, summarising evidence from 22 countries and comprising 83 methodologically distinct surveillance studies. No standardised approach was reported. The most common study type was community-based human testing (n = 42, 47.2%), followed by mosquito xenomonitoring (n = 23, 25.8%) and alternative (non-TAS) forms of school-based human testing (n = 19, 21.3%). Most studies were cross-sectional (n = 61, 73.5%) and used non-random sampling methods. 11 different human diagnostic tests were described. Results suggest that sensitivity of LF surveillance can be increased by incorporating newer human diagnostic tests (including antibody tests) and the use of mosquito xenomonitoring may be able to help identify and target areas of active transmission. Alternative sampling methods including the addition of adults to routine surveillance methods and consideration of community-based sampling could also increase sensitivity. The evidence base to support post-validation surveillance remains limited. Further research is needed on the diagnostic performance and cost-effectiveness of new diagnostic tests and methodologies to guide policy decisions and must be conducted in a range of countries. Evidence on how to integrate surveillance within other routine healthcare processes is also important to support the ongoing sustainability of LF surveillance.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Cross-Sectional Studies; Disease Eradication; Disease Transmission, Infectious; Drug Monitoring; Elephantiasis, Filarial; Epidemiological Monitoring; Female; Global Health; Humans; Infant; Infant, Newborn; Male; Mass Drug Administration; Middle Aged; Prevalence; Sensitivity and Specificity; Young Adult
PubMed: 32396575
DOI: 10.1371/journal.pntd.0008289 -
Clinical Chemistry and Laboratory... Feb 2021To compare indirect immunofluorescence (IIF) for antinuclear antibodies (ANA) against immunoassays (IAs) as an initial screening test for connective tissue diseases... (Meta-Analysis)
Meta-Analysis
A hierarchical bivariate meta-analysis of diagnostic test accuracy to provide direct comparisons of immunoassays vs. indirect immunofluorescence for initial screening of connective tissue diseases.
OBJECTIVES
To compare indirect immunofluorescence (IIF) for antinuclear antibodies (ANA) against immunoassays (IAs) as an initial screening test for connective tissue diseases (CTDs).
METHODS
A systematic literature review identified cross-sectional or case-control studies reporting test accuracy data for IIF and enzyme-linked immunosorbent assays (ELISA), fluorescence enzyme immunoassay (FEIA), chemiluminescent immunoassay (CLIA) or multiplex immunoassay (MIA). The meta-analysis used hierarchical, bivariate, mixed-effect models with random-effects by test.
RESULTS
Direct comparisons of IIF with ELISA showed that both tests had good sensitivity (five studies, 2321 patients: ELISA: 90.3% [95% confidence interval (CI): 80.5%, 95.5%] vs. IIF at a cut-off of 1:80: 86.8% [95% CI: 81.8%, 90.6%]; p = 0.4) but low specificity, with considerable variance across assays (ELISA: 56.9% [95% CI: 40.9%, 71.5%] vs. IIF 1:80: 68.0% [95% CI: 39.5%, 87.4%]; p = 0.5). FEIA sensitivity was lower than IIF sensitivity (1:80: p = 0.005; 1:160: p = 0.051); however, FEIA specificity was higher (seven studies, n = 12,311, FEIA 93.6% [95% CI: 89.9%, 96.0%] vs. IIF 1:80 72.4% [95% CI: 62.2%, 80.7%]; p < 0.001; seven studies, n = 3251, FEIA 93.5% [95% CI: 91.1%, 95.3%] vs. IIF 1:160 81.1% [95% CI: 73.4%, 86.9%]; p < 0.0001). CLIA sensitivity was similar to IIF (1:80) with higher specificity (four studies, n = 1981: sensitivity 85.9% [95% CI: 64.7%, 95.3%]; p = 0.86; specificity 86.1% [95% CI: 78.3%, 91.4%]). More data are needed to make firm inferences for CLIA vs. IIF given the wide prediction region. There were too few studies for the meta-analysis of MIA vs. IIF (MIA sensitivity range 73.7%-86%; specificity 53%-91%).
CONCLUSIONS
FEIA and CLIA have good specificity compared to IIF. A positive FEIA or CLIA test is useful to support the diagnosis of a CTD. A negative IIF test is useful to exclude a CTD.
Topics: Antibodies, Antinuclear; Connective Tissue Diseases; Cross-Sectional Studies; Diagnostic Tests, Routine; Enzyme-Linked Immunosorbent Assay; Fluorescent Antibody Technique, Indirect; Humans; Immunoassay
PubMed: 32352399
DOI: 10.1515/cclm-2020-0094 -
Vox Sanguinis May 2020In adult immune thrombocytopenia (ITP), an acquired autoimmune bleeding disorder, anti-platelet autoantibody testing may be useful as a rule-in test. Childhood ITP has...
BACKGROUND
In adult immune thrombocytopenia (ITP), an acquired autoimmune bleeding disorder, anti-platelet autoantibody testing may be useful as a rule-in test. Childhood ITP has different disease characteristics, and the diagnostic and prognostic value of anti-platelet antibody testing remains uncertain.
OBJECTIVE
To systematically review the diagnostic accuracy of anti-platelet autoantibody testing in childhood ITP.
METHODS
PubMed and EMBASE were searched for studies evaluating immunoassays in childhood ITP. Study quality was assessed (QUADAS2), and evidence was synthesized descriptively.
RESULTS
In total, 40 studies (1606 patients) were identified. Nine studies reported sufficient data to determine diagnostic accuracy measures. Anti-platelet IgG antibody testing showed a moderate sensitivity (0·36-0·80 platelet-associated IgG [direct test]; 0·19-0·39 circulating IgG [indirect test]). In studies that reported control data, including patients with non-immune thrombocytopenia, specificity was very good (0·80-1·00). Glycoprotein-specific immunoassays showed comparable sensitivity (three studies) and predominantly identified IgG anti-GP IIb/IIIa antibodies, with few IgG anti-GP Ib/IX antibodies. Anti-platelet IgM antibodies were identified in a substantial proportion of children (sensitivity 0·62-0·64 for direct and indirect tests).
CONCLUSION
The diagnostic evaluation of IgG and IgM anti-platelet antibodies may be useful as a rule-in test for ITP. In children with insufficient platelets for a direct test, indirect tests may be performed instead. A negative test does not rule out the diagnosis of ITP. Future studies should evaluate the value of anti-platelet antibody tests in thrombocytopenic children with suspected ITP.
Topics: Autoantibodies; Child; Humans; Immunoassay; Platelet Glycoprotein GPIIb-IIIa Complex; Platelet Glycoprotein GPIb-IX Complex; Purpura, Thrombocytopenic, Idiopathic; Sensitivity and Specificity; Serologic Tests
PubMed: 32080872
DOI: 10.1111/vox.12894 -
BMC Pregnancy and Childbirth Feb 2020All non-sensitized Rhesus D (RhD)-negative pregnant women in Germany receive antenatal anti-D prophylaxis without knowledge of fetal RhD status. Non-invasive prenatal...
BACKGROUND
All non-sensitized Rhesus D (RhD)-negative pregnant women in Germany receive antenatal anti-D prophylaxis without knowledge of fetal RhD status. Non-invasive prenatal testing (NIPT) of cell-free fetal DNA in maternal plasma could avoid unnecessary anti-D administration. In this paper, we systematically reviewed the evidence on the benefit of NIPT for fetal RhD status in RhD-negative pregnant women.
METHODS
We systematically searched several bibliographic databases, trial registries, and other sources (up to October 2019) for controlled intervention studies investigating NIPT for fetal RhD versus conventional anti-D prophylaxis. The focus was on the impact on fetal and maternal morbidity. We primarily considered direct evidence (from randomized controlled trials) or if unavailable, linked evidence (from diagnostic accuracy studies and from controlled intervention studies investigating the administration or withholding of anti-D prophylaxis). The results of diagnostic accuracy studies were pooled in bivariate meta-analyses.
RESULTS
Neither direct evidence nor sufficient data for linked evidence were identified. Meta-analysis of data from about 60,000 participants showed high sensitivity (99.9%; 95% CI [99.5%; 100%] and specificity (99.2%; 95% CI [98.5%; 99.5%]).
CONCLUSIONS
NIPT for fetal RhD status is equivalent to conventional serologic testing using the newborn's blood. Studies investigating patient-relevant outcomes are still lacking.
Topics: Chemoprevention; Female; Fetal Blood; Humans; Infant, Newborn; Medical Overuse; Noninvasive Prenatal Testing; Pregnancy; Pregnancy Complications, Hematologic; Prenatal Care; Rh Isoimmunization; Rh-Hr Blood-Group System; Rho(D) Immune Globulin
PubMed: 32033599
DOI: 10.1186/s12884-020-2742-4 -
The Cochrane Database of Systematic... Jan 2020Chlamydia trachomatis (C trachomatis) is one of the most frequent sexually transmitted infections and a source of deleterious effects on the reproductive health of men... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chlamydia trachomatis (C trachomatis) is one of the most frequent sexually transmitted infections and a source of deleterious effects on the reproductive health of men and women. Because this infection is likely asymptomatic and is associated with subfertility, ectopic pregnancy, and chronic pain, its presence needs to be confirmed. Technologies available for the diagnosis of C trachomatis infection can be classified into tests performed in a laboratory and rapid tests at the point of care (POC tests). Laboratory-based tests include culture, nucleic acid amplification tests, enzyme immunoassays (EIA), direct fluorescent antibody, nucleic acid hybridization, and transformation tests. Rapid tests include solid-phase EIA and solid-phase optical immunoassay. POC tests can be performed within 30 minutes without the need for expensive or sophisticated equipment. The principal advantage of this technology is the immediate presentation of results with the subsequent possibility to start the treatment of infected patients immediately.
OBJECTIVES
To determine the diagnostic accuracy of rapid point-of-care (POC) testing for detecting urogenital C trachomatis infection in nonpregnant women and men of reproductive age, as verified with nucleic acid amplification tests (NAATs) as the reference standard.
SEARCH METHODS
In November 2019 we searched CENTRAL, MEDLINE, Embase and LILACS. We also searched Web of Science, two trials registries and an abstract database. We screened reference lists of included studies for additional references.
SELECTION CRITERIA
We included diagnostic accuracy studies of symptomatic or asymptomatic nonpregnant women and men reproductive age. Included trials should have prospectively enrolled participants without previous diagnostic testing, co-infections or complications and consecutively or through random sampling at primary or secondary care facilities. Only studies reporting that all participants received the index test and the reference standard and presenting 2 x 2 data were eligible for inclusion. We excluded diagnostic case-control studies.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles and abstracts for relevance. Two review authors independently, and in duplicate, assessed eligibility, extracted data, and carried out quality assessment. We resolved differences through consensus or by involving a third review author. We assessed studies for methodological quality using QUADAS-2 and used meta-analysis to combine the results of studies using the bivariate approach to estimate the expected sensitivity and specificity values. We assessed the quality of the evidence using GRADE criteria and explored sources of heterogeneity.
MAIN RESULTS
We included a total of 19 studies, with 13,676 participants, that assessed the diagnostic accuracy of POC tests for C trachomatis infection in nonpregnant women and men of reproductive age, as verified with NAATs as the reference standard. Rapid tests were provided by the distributors in nine studies. Seven studies recruited a predominantly high risk or symptomatic population; the studies were conducted in America, Asia, Africa, Europe and Oceania, with a median prevalence of 10% (range 8% to 28%); nine different brands were assessed. The mean sensitivity for rapid tests for detecting urogenital infection was 0.48 (95% confidence interval (CI) 0.39 to 0.58; low-quality evidence) with a mean specificity of 0.98 (95% CI 0.97 to 0.99; moderate-quality evidence). We explored sources of heterogeneity by looking into differences in diagnostic accuracy according to the specimen (endocervical versus urine or vaginal), symptoms among participants (symptomatic versus asymptomatic), and setting (low/middle-income versus high-income countries). Likelihood ratio tests were not significantly different in terms of sensitivity or specificity by specimen (P = 0.27) or setting (P = 0.28); for this reason, these covariates do not appear to explain the observed variability. Included studies did not provide enough information to assess the 'presence of symptoms' covariate. We downgraded the quality of evidence because of some limitations in applicability and heterogeneity.
AUTHORS' CONCLUSIONS
Based on the results of this systematic review, the POC test based on antigen detection has suboptimal sensitivity but good specificity. Performance of this test translates, on average, to a 52% chance of mistakenly indicating absence of infection and a 2% chance of mistakenly pointing to the presence of this condition. Because of its deleterious consequences for reproductive health, and considering the current availability of safe and effective interventions to treat C trachomatis infection, the POC screening strategy should not be based on a rapid diagnostic test for antigen detection. Research in this topic should focus on different technologies.
Topics: Adult; Chlamydia Infections; Chlamydia trachomatis; False Negative Reactions; False Positive Reactions; Female; Humans; Male; Point-of-Care Systems; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Sexually Transmitted Diseases, Bacterial
PubMed: 31995238
DOI: 10.1002/14651858.CD011708.pub2 -
Annals of Translational Medicine Nov 2019Serologic assays for specific immunoglobulin G (IgG) antibodies are available for diagnosing the condition of bird fancier's lung, however, their usefulness is...
BACKGROUND
Serologic assays for specific immunoglobulin G (IgG) antibodies are available for diagnosing the condition of bird fancier's lung, however, their usefulness is controversial. This systematic review was aimed at investigating the diagnostic accuracy of specific IgG antibodies used for avian antigens.
METHODS
Medline, Embase, the Cochrane Library, the International Clinical Trials Registry Platform, and the Web of Science were searched for studies performed to evaluate the diagnostic accuracy of the Ouchterlony method, enzyme-linked immunosorbent assays (ELISAs), electrosyneresis, and ImmunoCAP assays for diagnosing bird fancier's lung. Nine articles were included in the meta-analysis. The pooled sensitivity and specificity were summarized using a bivariate mixed-effects model, and a hierarchical summary receiver operating characteristic curve was rendered to determine the diagnostic accuracy of the antibodies.
RESULTS
The pooled sensitivities and specificities of each specific IgG antibody were 82.9% (95% confidence interval, 71.1-90.5%) and 93.0% (95% confidence interval, 74.4-98.4%) for the Ouchterlony method, 92.5% (95% confidence interval, 71.3-98.4%) and 90.8% (95% confidence interval, 72.1-97.4%) for ELISAs, 90.0% (95% confidence interval, 55.5-99.7%) and 84.6% (95% confidence interval, 73.5-92.4%) for the electrosyneresis method, and 43.5% (95% confidence interval, 35.3-52.1%) and 100% (95% confidence interval, 0-100%) for ImmunoCAP assays. The overall quality of the collective evidence was low, primarily due to the high risk of bias, indirectness, and imprecision of the included studies.
CONCLUSIONS
The Ouchterlony method demonstrated high specificity, the ELISA method showed high sensitivity, and the diagnostic utilities of electrosyneresis and ImmunoCAP assay testing remain unclear.
PubMed: 31930056
DOI: 10.21037/atm.2019.10.65 -
Frontiers in Oncology 2019We collected previous published data and performed a systematical assessment for the diagnostic value of serum Zta antibody in NPC patients. Using bivariate-mixed effect...
We collected previous published data and performed a systematical assessment for the diagnostic value of serum Zta antibody in NPC patients. Using bivariate-mixed effect model, we calculated the sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnosis odds ratio (DOR), and summary receiver operating characteristics curve (AUC) and their 95% confidence intervals (CIs). We also performed subgroup analysis to explore the heterogeneity. We included 23 studies including 24 pieces of data and 17,770 study subjects (2,126 cases and 15,644 controls). The overall combined sensitivity was 0.85 (95%CI: 0.80-0.89) and the combined specificity was 0.90 (95%CI: 0.87-0.93). The summarized AUC was 0.94 with 95%CI of 0.92-0.96. The PLR was 8.9 (95%CI: 6.4-12.2) and the NLR was 0.17(95%CI: 0.12-0.23). The diagnostic odds ratio was 53 (95%CI: 32-87). For publication year, the sensitivity was 0.88 (95%CI: 0.84-0.91) and the specificity was 0.90 (95%CI: 0.84-0.93) for ≤2006. The AUC, PLR, NLR and DOR were 0.94, 8.8, 0.13, and 64. The pooled results were similar for >2006 group. For different sample size, the pooled AUC was 0.94 for ≤Median and was 0.95 for >Median that were very close to the overall estimations. For different population setting, no overlap was found in the sensitivity (0.84 vs. 0.87), specificity (0.90 vs. 0.84), PLR (8.7 vs. 5.5), NLR (0.16 vs. 0.08-0.33), DOR (49 vs. 35), and AUC (0.94 vs. 0.92) between Asian and others. The serum EBV antibody examination has high diagnostic accuracy for early-stage NPC. The diagnostic accuracy seems not to be influenced by sample size, publication year, and ethnic. Considering the few numbers of study with non-Asian population, the present results need to be confirmed in other population setting.
PubMed: 31921648
DOI: 10.3389/fonc.2019.01391