BACKGROUND: The postoperative complication rate is 30-64% among patients undergoing muscle-invasive and recurrent high-risk non-muscle-invasive bladder cancer surgery. Preoperative risky alcohol use increases the risk. The aim was to evaluate the accuracy of markers for identifying preoperative risky alcohol.
METHODS: Diagnostic test sub-study of a randomized controlled trial (STOP-OP trial), based on a cohort of 94 patients scheduled for major bladder cancer surgery. Identification of risky alcohol use using Timeline Follow Back interviews (TLFB) were compared to the AUDIT-C questionnaire and three biomarkers: carbohydrate-deficient transferrin in plasma (P-CDT), phosphatidyl-ethanol in blood (B-PEth), and ethyl glucuronide in urine (U-EtG).
RESULTS: The correlation between TLFB and AUDIT-C was strong (ρ = 0.75), while it was moderate between TLFB and the biomarkers (ρ = 0.55-0.65). Overall, sensitivity ranged from 56 to 82% and specificity from 38 to 100%. B-PEth showed the lowest sensitivity at 56%, but the highest specificity of 100%. All tests had high positive predictive values (79-100%), but low negative predictive values (42-55%).
CONCLUSIONS: Despite high positive predictive values, negative predictive values were weak compared to TLFB. For now, TLFB interviews seem preferable for preoperative identification of risky alcohol use.

This study aimed to determine the sensitivity (Se) and specificity (Sp) of a circulating pathogen-specific biomarker (polyketide synthetase 5, Pks5)-based enzyme-linked immunosorbent assay (ELISA) independently or in conjunction with a caudal fold tuberculin (CFT) test for bovine tuberculosis (bTB) screening in dairy cattle. We enrolled 987 dairy cows from 34 herds in Chiang Mai province, Thailand. A conditionally independent Bayesian model with a single population was inferred from the test results. The percentage of positive results for the Pks5-ELISA using 0.4 OD cutoff test and CFT test were 9.0% (89/987) and 10.5% (104/987), respectively. The median of posterior estimates of Se for the Pks5-ELISA test was 90.2% (95% posterior probability interval [PPI] = 76.6-97.4%), while the estimated Sp was slightly higher (median = 92.9, 95% PPI = 91.0-94.5%). The median estimated Se of the CFT test was 85.9% (95% PPI = 72.4-94.6%), while the estimated Sp was higher, with a median of 90.7% (95% PPI = 88.7-92.5%). The posterior estimate for true disease prevalence was 2.4% (95% PPI = 1.2-3.9%). The Pks5-ELISA test yielded characteristics at or above the acceptable standards for bTB detection. Therefore, the pathogen-specific biomarker, Pks5, is a potential detection system for bTB screening and may be applied as an ancillary test together with the currently applied standard method (CFT test) to reinforce the bTB control and eradication programs.

The first point-of-care (PoC) test (v-RetroFel®; modified version 2021) determining the presence of FeLV p27 antigen and FeLV anti-p15E antibodies has become recently commercially available to identify different feline leukaemia virus (FeLV) infection outcomes. This study aimed to assess this PoC test\'s performance concerning FeLV p27 antigen and FeLV anti-p15E antibody detection. Sensitivity, specificity, positive and negative predictive values (PPV, NPV) were assessed after ten minutes (recommended) and 20 min (prolonged) incubation times. The test results were evaluated as either positive or negative. Serum samples from 934 cats were included, originating from Italy (n = 269), Portugal (n = 240), Germany (n = 318), and France (n = 107). FeLV p27 antigen and anti-p15E antibodies were measured by reference standard ELISAs and compared to the PoC test results. The PoC test was easy to perform and the results easy to interpret. Sensitivity and specificity for FeLV p27 antigen were 82.8% (PPV: 57.8%) and 96.0% (NPV: 98.8%) after both, ten and 20 minues of incubation time. Sensitivity and specificity for anti-p15E antibodies were 31.4% (PPV: 71.6%) and 96.9% (NPV: 85.1%) after ten minutes incubation time; sensitivity was improved by a prolonged incubation time (20 min) to 40.0% (PPV: 76.3%), while specificity remained the same (96.9%, NPV: 86.7%). Despite the improved sensitivity using the prolonged incubation time, lower than ideal sensitivities for both p27 antigen and especially anti-p15E antibodies were found, indicating that the PoC test in its current version needs further improvement prior to application in the field.

Using nasopharyngeal (NP) swab samples instead of lower respiratory tract specimens for polymerase chain reaction (PCR) to diagnose Pneumocystis jirovecii pneumonia (PJP) may be better tolerated and improve diagnostic accessibility. In this 2-year Australian retrospective cohort study of patients with clinically suspected PJP, P jirovecii PCR on NP swab samples had perfect specificity but low sensitivity (0.66).

BACKGROUND: The estimation of fetal weight by fetal magnetic resonance imaging is a simple and rapid method with a high sensitivity in predicting birthweight in comparison with ultrasound. Several national and international growth charts are currently in use, but there is substantial heterogeneity among these charts due to variations in the selected populations from which they were derived, in methodologies, and in statistical analysis of data.
OBJECTIVE: This study aimed to compare the performance of magnetic resonance imaging and ultrasound for the prediction of birthweight using 3 commonly used fetal growth charts: the INTERGROWTH-21st Project, World Health Organization, and Fetal Medicine Foundation charts.
METHODS: Data derived from a prospective, single-center, blinded cohort study that compared the performance of magnetic resonance imaging and ultrasound between 36+0/7 and 36+6/7 weeks of gestation for the prediction of birthweight ≥95th percentile were reanalyzed. Estimated fetal weight was categorized as above or below the 5th, 10th, 90th, and 95th percentile according to the 3 growth charts. Birthweight was similarly categorized according to the birthweight standards of each chart. The performances of ultrasound and magnetic resonance imaging for the prediction of birthweight <5th, <10th, >90th, and >95th percentile using the different growth charts were compared. Data were analyzed with R software, version 4.1.2. The comparison of sensitivity and specificity was done using McNemar and exact binomial tests. P values <.05 were considered statistically significant.
RESULTS: A total of 2378 women were eligible for final analysis. Ultrasound and magnetic resonance imaging were performed at a median gestational age of 36+3/7 weeks, delivery occurred at a median gestational age of 39+3/7 weeks, and median birthweight was 3380 g. The incidences of birthweight <5th and <10th percentiles were highest with the Fetal Medicine Foundation chart and lowest with the INTERGROWTH-21st chart, whereas the incidences of birthweight >90th and >95th percentiles were lowest with the Fetal Medicine Foundation chart and highest with the INTERGROWTH-21st chart. The sensitivity of magnetic resonance imaging with an estimated fetal weight >95th percentile in the prediction of birthweight >95th percentile was significantly higher than that of ultrasound across the 3 growth charts; however, its specificity was slightly lower than that of ultrasound. In contrast, the sensitivity of magnetic resonance imaging with an estimated fetal weight <10th percentile for predicting birthweight <10th percentile was significantly lower than that of ultrasound in the INTERGROWTH-21st and Fetal Medicine Foundation charts, whereas the specificity and positive predictive value of magnetic resonance imaging were significantly higher than those of ultrasound for all 3 charts. Findings for the prediction of birthweight >90th percentile were close to those of birthweight >95th percentile, and findings for the prediction of birthweight <5th percentile were close to those of birthweight <10th percentile.
CONCLUSIONS: The sensitivity of magnetic resonance imaging is superior to that of ultrasound for the prediction of large for gestational age fetuses and inferior to that of ultrasound for the prediction of small for gestational age fetuses across the 3 different growth charts. The reverse is true for the specificity of magnetic resonance imaging in comparison with that of ultrasound.

UNASSIGNED: Stool DNA testing for early detection of colorectal cancer (CRC) is a non-invasive technology with the potential to supplement established CRC screening tests. The aim of this health technology assessment was to evaluate effectiveness and safety of currently CE-marked stool DNA tests, compared to other CRC tests in CRC screening strategies in an asymptomatic screening population.
UNASSIGNED: The assessment was carried out following the guidelines of the European Network for Health Technology Assessment (EUnetHTA). This included a systematic literature search in MED-LINE, Cochrane and EMBASE in 2018. Manufacturers were asked to provide additional data. Five patient interviews helped assessing potential ethical or social aspects and patients\' experiences and preferences. We assessed the risk of bias using QUADAS-2, and the quality of the body of evidence using GRADE.
UNASSIGNED: We identified three test accuracy studies, two of which investigated a multitarget stool DNA test (Cologuard®, compared fecal immunochemical test (FIT)) and one a combined DNA stool assay (ColoAlert®, compared to guaiac-based fecal occult blood test (gFOBT), Pyruvate Kinase Isoenzyme Type M2 (M2-PK) and combined gFOBT/M2-PK). We found five published surveys on patient satisfaction. No primary study investigating screening effects on CRC incidence or on overall mortality was found. Both stool DNA tests showed in direct comparison higher sensitivity for the detection of CRC and (advanced) adenoma compared to FIT, or gFOBT, respectively, but had lower specificity. However, these comparative results may depend on the exact type of FIT used. The reported test failure rates were higher for stool DNA testing than for FIT. The certainty of evidence was moderate to high for Cologuard® studies, and low to very low for the ColoAlert® study which refers to a former version of the product and yielded no direct evidence on the test accuracy for ad-vanced versus non-advanced adenoma.
UNASSIGNED: ColoAlert® is the only stool DNA test currently sold in Europe and is available at a lower price than Cologuard®, but reliable evidence is lacking. A screening study including the current product version of ColoAlert® and suitable comparators would, therefore, help evaluate the effectiveness of this screening option in a European context.
UNASSIGNED: Stuhl-DNA-Tests zur Früherkennung des kolorektalen Karzinoms (KRK) sind nicht-invasiv und können etablierte KRK-Screening-Verfahren ergänzen. Ziel dieses Health Technology Assessment war die Untersuchung der Wirksamkeit und Sicherheit von CE-zertifizierten Stuhl-DNA-Tests im Vergleich zu anderen Tests für ein Screening einer asymptomatischen KRK-Screening-Population.
UNASSIGNED: Das Assessment wurde nach den Richtlinien des Europäischen Netzwerks für Health Technology Assessment (EUnetHTA) durchgeführt und schloss eine systematische Literaturrecherche in MEDLINE, Cochrane und EMBASE ein, durchgeführt 2018. Die Hersteller wurden bezüglich der Übermittlung von weiteren Daten kontaktiert. Fünf Patienteninterviews halfen in der Einschätzung möglicher ethischer oder sozialer Aspekte sowie von Patientenerfahrungen und -präferenzen. Wir bewerteten das Verzerrungsrisiko mit QUADAS-2 und verwendeten GRADE, um die Qualität der Evidenz zu bewerten.
UNASSIGNED: Wir identifizierten drei Studien zur Testgenauigkeit; zwei untersuchten einen Multitarget-Stuhl-DNA-Test (Cologuard®, im Vergleich zu einem fäkalen immunchemischen Test (FIT)) und eine Studie einen kombinierten DNA-Stuhltest (ColoAlert®, im Vergleich zu einem guajakbasierten Stuhlbluttest (gFOBT), Pyruvate Kinase Isoenzyme Typ M2 (M2-PK) und kombiniertem gFOBT/M2-PK). Wir fanden fünf publizierte Erhebungen zur Patientenzufriedenheit, jedoch keine Primärstudien zu den Auswirkungen eines Screenings mit den beiden Tests auf KRK oder die Gesamtmortalität. Beide Stuhl-DNA-Tests zeigten im direkten Vergleich eine höhere Sensitivität für den Nachweis von KRK und (fortgeschrittenen) Adenomen als FIT beziehungsweise gFOBT, wiesen aber eine geringere Spezifität auf. Diese Ergebnisse könnten jedoch vom genauen Typ des jeweils verwendeten FIT abhängen. Die berichteten Testausfallraten waren beim Stuhl-DNA-Test höher als beim FIT. Die Stärke der Evidenz war moderat bis hoch für die Cologuard®-Studien und niedrig bis sehr niedrig für die ColoAlert®-Studie, die sich auf eine frühere, nicht mehr am Markt befindliche Version des Produkts bezieht und die in den Ergebnissen zur Testgenauigkeit nicht zwischen fortgeschrittenen und nicht-fortgeschrittenen Adenomen differenzierte.
UNASSIGNED: ColoAlert® ist der einzige derzeit in Europa am Markt befindliche Stuhl-DNA-Test und ist zu einem niedrigeren Preis als Cologuard® erhältlich, jedoch fehlt zuverlässige Evidenz. Eine Screening-Studie mit Implementierung der aktuellen Produktversion von ColoAlert® und geeigneten Komparatoren würde daher helfen, diese Screening-Option im europäischen Kontext zu evaluieren.

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In 2014, Ontario\'s Point-of-Care (POC) test providers were advised to focus efforts on provincially defined priority populations who experience a greater risk of HIV. Our objective was to describe the POC program before, during and after this change, including tester characteristics, follow-up testing results, positive predictive value (PPV) over time, and trends and characteristics of those with reactive test results without a confirmatory serological specimen.
Test-level data of POC screening and confirmatory results were extracted from the Public Health Ontario HIV Datamart. Final test results were defined based on results of the confirmatory blood sample, or the POC test for \"non-reactive\" tests. Testing volumes, percent of total tests, percent positivity and PPV were calculated overall, annually, and by exposure group.
Overall testing volumes decreased by 39.8% between 2014 and 2018. The majority of confirmed positive tests were in the men who have sex with men (MSM) exposure category, followed by HIV-endemic and heterosexual - no identified risk (heterosexual-NIR). Overall percent positivity decreased from 0.59% in 2011 to 0.42% in 2015 (change of 0.17%, 95% CI 0.03% to 0.31%), increasing to 0.69% in 2018 (change of 0.27%, 95% CI 0.20% to 0.34%). Increases in percent positivity corresponded with a decrease in the overall proportion of tests conducted in low-risk populations. When compared to the heterosexual-NIR category, PPV was significantly higher for men who have sex with men - people who use injection drugs (MSM-PWID) (52.7% compared to 100%, P < .001), MSM (52.7% compared to 95.4%, P < .001), HIV-endemic (52.7% compared to 91.5%, P < .001), heterosexual - partner with identified risk (heterosexual-PIR) (52.7% compared to 77.3%, P = .042), and people who use injection drugs (PWID) (52.7% compared to 81.3%, P = 0.007). A total of 13.5% of reactive POC results did not have a serological sample submitted.
Targeted testing towards populations at higher risk of HIV improved the overall test performance characteristics of Ontario\'s POC testing program. While not unexpected, the large discrepancies between PPV in higher-risk, compared to lower-risk populations, suggests the need for greater awareness and messaging of the likelihood of false positive test results in different populations.

Assessment of liver fibrosis is important as the range of liver disease management has expanded, rendering biopsy both imperfect and impractical in many situations. Noninvasive tests of fibrosis leverage laboratory, imaging and elastography techniques to estimate disease extent, often with the goal of identifying advanced fibrosis. This review attempts to summarize their utility across a broad range of possible clinical scenarios while considering the central tenets of health care quality: access, quality, and cost. For each test, it also discusses the caveats whereby each test may have reduced effectiveness and how to consider each in a typical clinical setting.

Detection of seroconversion after SARS-CoV-2-infection or vaccination is relevant to discover subclinical cases and recognize patients with a possible immunity.
Test performance, effects of age, time-point of seroconversion and immune status regarding neutralizing antibodies (NAbs) and T-cell-reactivity were investigated.
Two antibody assays (Viramed-Test for S/N-specific IgG, Roche-Test for N-specific IgA, -M, -G) were evaluated with classified samples. In total, 381 subjects aged 6-99 years, who had either recovered from the disease or had been vaccinated, were screened for SARS-CoV-2-specific antibodies. This screening was part of an open observational study with working adults. Additionally, children and adults were analyzed in a longitudinal COVID-19 study in schools. For immunity evaluation, virus neutralization tests and ELISpot tests were performed in a subgroup of subjects.
Viramed revealed a slightly lower test performance than Roche, but test quality was equally well in samples from very young or very old donors. The time-point of seroconversion after the respective immunization detected by the two tests was not significantly different. N-specific antibodies, detected with Roche, highly correlated with NAbs in recovered subjects, whereas a positive Viramed-Test result was paralleled by a positive ELISpot result.
Viramed-Test was not as sensitive as Roche-Test, but highly specific and beneficial to distinguish between recovered and vaccinated status. For both tests correlations with humoral and cellular immunity were found. Of note, the expected early detection of IgA and IgM by the Roche-Test did not prove to be an advantage over IgG testing by Viramed.