Stonebraker Elizabeth, Greene Wallace, Taylor Stephanie N, Cammarata Catherine L, Bobenchik April, Lockamy Elizabeth
Becton, Dickinson and Company, BD Life Sciences-Diagnostic Solutions, Sparks, Maryland, USA.
Department of Pathology and Laboratory Medicine, Milton S. Hershey Medical Center, Penn State College of Medicine, Hershey, Pennsylvania, USA.
Microbiol Spectr. 2024 Aug 6;12(8):e0023524. doi: 10.1128/spectrum.00235-24. Epub 2024 Jun 20.
Molecular-based assays demonstrate excellent sensitivity for the detection of vaginitis causes. Here, the high-throughput BD Vaginal Panel for BD COR System (VP-COR) performance was compared to that of the predicate, BD MAX Vaginal Panel for BD MAX System (VP-MAX). Clinical or contrived samples were used to determine the agreement between VP-COR and VP-MAX. Acceptance criteria for VP-COR agreement were as follows: bacterial vaginosis (BV) required a positive percent agreement (PPA) point estimate of ≥95% and a negative percent agreement (NPA) point estimate of ≥98%; group, , , and (TV) required a PPA and NPA point estimate of ≥95% [with lower bound of 95% confidence interval (95% CI) ≥90%]. PPA was 99.5% (95% CI: 97.5-100) and 97.9% (95% CI: 96.5-98.8) for BV contrived ( = 516) and BV clinical ( = 1,050) specimens, respectively. For the group (clinical; = 724), (contrived; = 544), (contrived; = 522), and TV (clinical; = 702), PPA was 99.4% (95% CI: 98.0-99.9), 100% (95% CI: 97.9-100), 100% (95% CI: 97.6-100), and 99.7% (95% CI: 98.3-100), respectively; the lowest lower bound CI value was 97.6%. NPA was >95% for BV contrived and BV clinical specimens. For the group, , , and TV, NPA was ≥98.9%; the lowest lower bound CI value was 97.3%. These results demonstrate the equivalent performance of the VP-COR assay when compared to VP-MAX.IMPORTANCEVaginitis is common among women of reproductive age, resulting in around 10 million office visits a year. Diagnosis is often difficult due to its multiple causes-including bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis-as well as variation in symptom presentation. Typically, cases are identified with a combination of symptomology, medical history, physical examination, and office- or laboratory-based testing. These traditional techniques involve subjective elements and demonstrate varying sensitivity and specificity. Inaccurate or delayed diagnosis leads to continued symptoms, repeat visits, inappropriate treatment, and unnecessary costs. Alternatively, the use of molecular-based assays increases sensitivity for the detection of vaginitis causes. With the validation of the vaginal panel molecular assay on COR (a high-throughput platform), a workflow can be streamlined in high-demand laboratories while providing high sensitivity for vaginitis detection.
基于分子的检测方法对阴道炎病因的检测具有出色的灵敏度。在此，将用于BD COR系统的高通量BD阴道检测板（VP-COR）的性能与作为对照的用于BD MAX系统的BD MAX阴道检测板（VP-MAX）进行了比较。使用临床样本或人工样本确定VP-COR与VP-MAX之间的一致性。VP-COR一致性的验收标准如下：细菌性阴道病（BV）要求阳性百分比一致性（PPA）点估计值≥95%，阴性百分比一致性（NPA）点估计值≥98%；滴虫性阴道炎（TV）要求PPA和NPA点估计值≥95%[95%置信区间（95%CI）下限≥90%]。对于人工制备的BV样本（n = 516）和临床BV样本（n = 1,050），PPA分别为99.5%（95%CI：97.5 - 100）和97.9%（95%CI：96.5 - 98.8）。对于阴道加德纳菌（临床样本；n = 724）、人型支原体（人工制备样本；n = 544）、解脲脲原体（人工制备样本；n = 522）和TV（临床样本；n = 702），PPA分别为99.4%（95%CI：98.0 - 99.9）、100%（95%CI：97.9 - 100）、100%（95%CI：97.6 - 100）和99.7%（95%CI：98.3 - 100）；最低的下限CI值为97.6%。人工制备的BV样本和临床BV样本的NPA>95%。对于阴道加德纳菌、人型支原体、解脲脲原体和TV，NPA≥98.9%；最低的下限CI值为97.3%。这些结果表明，与VP-MAX相比，VP-COR检测方法具有同等性能。
重要性
阴道炎在育龄女性中很常见，每年导致约1000万人次就诊。由于其病因多样，包括细菌性阴道病、外阴阴道假丝酵母菌病和滴虫性阴道炎，以及症状表现的差异，诊断往往很困难。通常，通过症状学、病史、体格检查以及基于门诊或实验室的检测相结合来确诊病例。这些传统技术包含主观因素，并且灵敏度和特异性各不相同。不准确或延迟的诊断会导致症状持续、再次就诊、不恰当的治疗以及不必要的费用。另外，使用基于分子的检测方法可提高对阴道炎病因的检测灵敏度。随着COR（一个高通量平台）上阴道检测板分子检测方法的验证，在需求较高的实验室中可以简化工作流程，同时为阴道炎检测提供高灵敏度。
