Dembele Benoit, Bah Mohamed Salieu, Conteh Abdulai, Kamara Habib I, Kargbo-Labour Ibrahim, Souza Ashley, Houck Patricia, Mensah Ernest O, Turay Victoria, Elder Eric Scott, Gass Katherine, Reid Steven D, Shott Joseph P, Zhang Yaobi, Won Kimberly Y, Weaver Angela
Helen Keller International, Regional Office for Africa, Dakar, Senegal.
Helen Keller International, Freetown, Sierra Leone.
PLoS Negl Trop Dis. 2025 Jul 28;19(7):e0012773. doi: 10.1371/journal.pntd.0012773. eCollection 2025 Jul.
As part of a multi-country evaluation, the SD Biosensor STANDARD Q Filariasis Antigen Test (QFAT) was compared with the Abbott Bioline Filariasis Test Strip (FTS) for assessing Wuchereria bancrofti infection prevalence and for ease of use of QFAT in field conditions in Sierra Leone.
The evaluation was done in two districts, Bombali and Karene, where repeat pre-transmission assessment surveys (pre-TAS) were planned. Two rural sites, Kagbo and Makorba Yelimini which recorded high LF antigen prevalence of 4.1% and 7.7% respectively in repeat pre-TAS in 2020 were selected for the QFAT evaluation. At least 350 people ≥5 years were targeted per site for inclusion in the study by convenience sampling. Blood was collected by fingerstick; 20μl for QFAT and 75μl for FTS. The reading time for both tests was 10 minutes. For all positive or invalid results, a repeat test was performed for both tests. In total, 728 participants (5-91 years) were tested by QFAT and FTS. Four FTS and three QFAT final results were classified as indeterminate (meaning a positive result followed by a negative result) and were excluded from the analysis. The positive rate was 4.8% (17/357) and 3.5% (13/367) for FTS and 3.4% (12/359) and 4.1% (15/366) for QFAT in Kagbo and Makorba Yelimi, respectively. All participants testing positive for FTS or QFAT underwent further testing by night blood smear to detect microfilariae using microscopy. No W. bancrofti microfilariae was detected in any of the antigen positive cases. In field conditions, QFAT was easy to handle and recorded zero invalid tests compared to FTS (six invalids). The concordance between FTS and QFAT was 0.81 (Cohen's Kappa). The discrepancy found between the two tests in terms of positive tests was not statistically significant (p = 0.78).
CONCLUSIONS/SIGNIFICANCE: The results suggest that the QFAT is a credible W. bancrofti diagnostic test when compared to the routinely used FTS; use of either test would result in the same program decision.
作为一项多国评估的一部分,将SD生物传感器标准Q丝虫病抗原检测(QFAT)与雅培Bioline丝虫病检测试纸(FTS)进行比较,以评估班氏吴策线虫感染率,并评估QFAT在塞拉利昂现场条件下的易用性。
评估在邦巴利和卡雷内两个地区进行,这两个地区计划开展重复的传播前评估调查(pre-TAS)。选择了两个农村地点,即卡博和马科尔巴耶利米尼,在2020年的重复pre-TAS中,这两个地点的淋巴丝虫抗原流行率分别高达4.1%和7.7%,用于QFAT评估。通过方便抽样,每个地点至少选取350名年龄≥5岁的人纳入研究。通过手指采血;QFAT取血20μl,FTS取血75μl。两种检测的读数时间均为10分钟。对于所有阳性或无效结果,两种检测均进行重复检测。共有728名参与者(5至91岁)接受了QFAT和FTS检测。FTS的4个最终结果和QFAT的3个最终结果被归类为不确定(即先出现阳性结果后出现阴性结果),并被排除在分析之外。在卡博和马科尔巴耶利米尼,FTS的阳性率分别为4.8%(17/357)和3.5%(13/367),QFAT的阳性率分别为3.4%(12/359)和4.1%(15/366)。所有FTS或QFAT检测呈阳性的参与者都通过夜间血涂片进行进一步检测,以使用显微镜检测微丝蚴。在任何抗原阳性病例中均未检测到班氏吴策线虫微丝蚴。在现场条件下,QFAT易于操作,与FTS(6个无效结果)相比,无效检测记录为零。FTS和QFAT之间的一致性为0.81(科恩kappa系数)。两种检测在阳性检测方面的差异无统计学意义(p = 0.78)。
结论/意义:结果表明,与常规使用的FTS相比,QFAT是一种可靠的班氏吴策线虫诊断检测方法;使用这两种检测方法中的任何一种都会导致相同的项目决策。