Institute of Human Virology, University of Maryland, PEPFAR AIDSRelief, P.O. Box 2454, Addis Ababa, Ethiopia.
Diagn Microbiol Infect Dis. 2013 Jan;75(1):55-9. doi: 10.1016/j.diagmicrobio.2012.09.020. Epub 2012 Oct 24.
Providing regular external quality assessment of primary level laboratories and timely feedback is crucial to ensure the reliability of testing capacity of the whole laboratory network. This study was aimed to assess the diagnostic performances of primary level laboratories in Southwest Showa Zone in Ethiopia. An external quality assessment protocol was devised whereby from among all the samples collected on-site at 4 health centers (HCs), each HC sent to a district hospital (DH) on a weekly basis 2 TB slides (1 Ziehl-Neelsen stained and another unstained), 2 malaria slides (1 Giemsa stained and another unstained), and 2 blood samples for HIV testing (1 whole blood and another plasma) for a comparative analysis. Similarly, the DH preserved the same amount and type of specimens to send to each HC for retesting. From October to November 2011, 192 single-blinded specimens were rechecked: 64 TB slides, 64 malaria slides, and 64 blood specimens for HIV testing. The analyses demonstrated an overall agreement of 95.3% (183/192) between the test and the retest, and 98.4% (63/64), 92.2% (59/64,) and 95.3% (61/64) for TB microscopy, malaria microscopy, and HIV rapid testing, respectively. Of the total TB slides tested positive, 20/23 (87%) were quantified similar in both laboratories. The agreement on HIV rapid testing was 100% (32/32) when plasma samples were tested either at HC (16/16) or at DH (16/16), while when whole blood specimens were tested, the agreement was 87.5% (14/16) and 93.8% (15/16) for samples prepared by HCs and DH, respectively. Results of this new approach proved that secondary laboratories could play a vital role in assuring laboratory qualities at primary level HCs, without depending on remotely located national and regional laboratories to provide this support.
为确保整个实验室网络的检测能力的可靠性,定期对基层实验室进行外部质量评估并及时反馈至关重要。本研究旨在评估埃塞俄比亚西南昭和区基层实验室的诊断性能。设计了一个外部质量评估方案,根据该方案,在 4 个卫生中心(HCs)现场采集的所有样本中,每个 HCs 每周向区医院(DH)发送 2 张结核病幻灯片(1 张 Ziehl-Neelsen 染色,另 1 张未染色)、2 张疟疾幻灯片(1 张吉姆萨染色,另 1 张未染色)和 2 份用于 HIV 检测的血液样本(1 份全血和 1 份血浆)进行比较分析。同样,DH 保留相同数量和类型的标本,以便送回各 HCs 进行重新检测。2011 年 10 月至 11 月,共重新检查了 192 份单盲标本:64 张结核病幻灯片、64 张疟疾幻灯片和 64 份用于 HIV 检测的血液标本。分析显示,检测与重测之间的总体一致性为 95.3%(183/192),结核病显微镜检查、疟疾显微镜检查和 HIV 快速检测的一致性分别为 98.4%(63/64)、92.2%(59/64)和 95.3%(61/64)。在检测为阳性的总结核病幻灯片中,23 张中有 20 张(87%)在两个实验室中定量相似。当在 HCs(16/16)或 DH(16/16)测试血浆样本时,HIV 快速检测的一致性为 100%(32/32),而当测试全血样本时,HCs 和 DH 制备的样本的一致性分别为 87.5%(14/16)和 93.8%(15/16)。这种新方法的结果证明,二级实验室可以在不依赖远程国家和地区实验室提供支持的情况下,在确保基层 HCs 的实验室质量方面发挥重要作用。