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Background Tuberculosis (TB) control is hindered by absence of rapid tests to identify Mycobacterium tuberculosis (MTB) and detect isoniazid (INH) and rifampin (RIF) resistance. We evaluated the accuracy of the BD MAX multidrug-resistant (MDR)-TB assay (BD MAX) in South Africa, Uganda, India, and Peru. Methods Outpatient adults with signs/symptoms of pulmonary TB were prospectively enrolled. Sputum smear microscopy and BD MAX were performed on a single raw sputum, which was then processed for culture and phenotypic drug susceptibility testing (DST), BD MAX, and Xpert MTB/RIF (Xpert). Results 1053 participants with presumptive TB were enrolled (47% female; 32% with human immunodeficiency virus). In patients with confirmed TB, BD MAX sensitivity was 93% (262/282 [95% CI, 89–95%]); specificity was 97% (593/610 [96–98%]) among participants with negative cultures on raw sputa. BD MAX sensitivity was 100% (175/175 [98–100%]) for smear-positive samples (fluorescence microscopy), and 81% (87/107 [73–88%]) in smear-negative samples. Among participants with both BD MAX and Xpert, sensitivity was 91% (249/274 [87–94%]) for BD MAX and 90% (246/274 [86–93%]) for Xpert on processed sputa. Sensitivity and specificity for RIF resistance compared with phenotypic DST were 90% (9/10 [60–98%]) and 95% (211/222 [91–97%]), respectively. Sensitivity and specificity for detection of INH resistance were 82% (22/27 [63–92%]) and 100% (205/205 [98–100%]), respectively. Conclusions The BD MAX MDR-TB assay had high sensitivity and specificity for detection of MTB and RIF and INH drug resistance and may be an important tool for rapid detection of TB and MDR-TB globally. [ABSTRACT FROM AUTHOR]

Background Vaginal symptoms are a leading cause of primary care visits for women. Individuals exhibiting symptoms often receive laboratory testing based on clinic-specific standards of care. Thus, women seen at a family practice clinic might only receive a vaginitis workup, whereas those seen at a sexually transmitted diseases clinic could be more likely to receive only sexually transmitted infection (STI) testing. Methods The likelihood of STIs was assessed in women from whom samples were tested for vaginitis using a molecular diagnostic assay. Positivity rates for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA, detected using the BD MAX CT/GC/TV assay, were calculated. Concordance between the BD MAX Vaginal Panel and the BD MAX CT/GC/TV assay for detection of T. vaginalis was determined. Results Women with bacterial vaginosis alone or with concurrent Candida spp infections had high rates of coinfection with sexually transmitted infections (24.4%–25.7%); samples from women who were negative for vaginitis had significantly lower positivity rates (7.9%; P <.001). Trichomonas vaginalis results were concordant between the BD MAX Vaginal Panel and the BD MAX CT/GC/TV assay in 559 of 560 samples tested. Conclusions These data suggest, as have other studies, that women with vaginitis symptoms may be at risk for an STI. Molecular testing could provide broad diagnostic coverage for symptomatic women and improve patient management, regardless of the type of clinic in which patients are treated. [ABSTRACT FROM AUTHOR]

• Performance of ADVIA Centaur NT-proBNP for acute HF in the ED was evaluated. • Dyspneic patients were placed into negative, indeterminate, and positive groups. • Patient gold standard AHF diagnosis rate was 3.7, 24.3, and 67.2 %, respectively. • Overall likelihood ratios (LR) were 0.07, 0.55, and 3.53 for the same groups. • The ADVIA Centaur PBNPII assay demonstrated acceptable clinical performance. Natriuretic peptide testing is guideline recommended as an aid to the diagnosis of heart failure (HF). We sought to evaluate the performance of the ADVIA Centaur (Siemens Healthcare Diagnostics, Tarrytown, NY) NT-proBNPII assay (PBNPII) in emergency department (ED) dyspneic patients. Eligible patients presented to the ED with dyspnea, with their gold standard diagnosis determined by up to 3 cardiologists blinded to the PBNPII results. Patients were stratified into 3 groups based on PBNPII resultsa rule out group of NT-proBNP<300 pg/mL, an age-specific rule in group using cutoffs of 450, 900, and 1800 pg/mL, for <50, 50–75, and > 75 years respectively, and an intermediate cohort for results between the rule out and rule in groups. Of 3128 eligible patients, 1148 (36.7 %) were adjudicated as acute heart failure (AHF). The gold standard AHF diagnosis rate was 3.7, 24.3, and 67.2 % for patients with NTproBNPII in the negative, indeterminate, and positive groups, respectively. Overall likelihood ratios (LR) were 0.07 (95 % CI: 0.05,0.09), 0.55 (0.45,0.67), and 3.53 (3.26,3.83) for the same groups, respectively. Individual LR+for age dependent cutoffs were 5.01 (4.25,5.91), 3.71 (3.25,4.24), and 2.38 (2.10,2.69), respectively. NTproBNPII increased with increasing severity of HF when stratified by NYHA classification. The ADVIA Centaur PBNPII assay demonstrates acceptable clinical performance using the recommended single rule out and age dependent rule in cutoffs for an AHF diagnosis in dyspneic ED patients. [ABSTRACT FROM AUTHOR]

Objective: Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of the trial was to evaluate the clinical accuracy of the investigational test for vaginal swabs collected by patients (self) or clinicians. The primary and secondary outcomes were to compare the investigational test with reference methods for the three most common causes of vaginitis and compare clinician-collected with self-collected swabs.Methods: We conducted a cross-sectional study in which women with symptoms of vaginitis were recruited at ten clinical centers and consented to the investigation between May and September 2015. The woman collected a vaginal swab, sheathed, and then handed it to the clinician. These swabs were to evaluate how self-collected swabs compared with clinician-collected swabs. The clinician collected an investigational test swab and reference test swabs. From 1,740 symptomatic patients, clinician-collected and self-collected vaginal swabs were evaluated by the molecular test and six tests. The reference methods for bacterial vaginosis were Nugent's score and Amsel's criteria for intermediate Nugent results. The reference methods for Candida infection were isolation of any potential Candida microorganisms from inoculation of two culture media: chromogenic and Sabouraud agar and sequencing. The reference methods for trichomoniasis were wet mount and culture.Results: For clinician-collected swabs, by reference methods, bacterial vaginosis was diagnosed in 56.5%, vaginal candidiasis in 32.8%, trichomoniasis in 8%, and none of the three infections in 24% with a coinfection rate of 20%. The investigational test sensitivity was 90.5% (95% confidence interval [CI] 88.3-92.2%) and specificity was 85.8% (95% CI 83.0-88.3%) for bacterial vaginosis. The investigational test sensitivity was 90.9% (95% CI 88.1-93.1%) and specificity was 94.1% (95% CI 92.6-95.4%) for the Candida group. Sensitivity for Candida glabrata was 75.9% (95% CI 57.9-87.8%) and specificity was 99.7% (95% CI 99.3-99.9%). Investigational test sensitivity was 93.1% (95% CI 87.4-96.3%) and specificity was 99.3% (95% CI 98.7-99.6%) for trichomoniasis. Results from self-collected swabs were similar to clinician-collected swabs.Conclusion: A molecular-based test using vaginal swabs collected by clinicians or patients can accurately diagnose most common bacterial, fungal, and protozoan causes of vaginitis. Women and their clinicians seeking accurate diagnosis and appropriate selection of efficacious treatment for symptoms of vaginitis might benefit from this molecular test. [ABSTRACT FROM AUTHOR]