2015 - 2016年期间MOTAKK丙型肝炎病毒RNA基因分型和丁型肝炎病毒外部质量评估项目结果评估

Evaluation of the results of MOTAKK hepatitis C virus RNA genotyping and hepatitis delta virus external quality assessment programs during 2015-2016.

作者信息

Karataylı Ersin, Soydemir Ege, Aksoy Zeynep Büşra, Kızılpınar Mehtap, Altay Koçak Aylin, Karataylı Senem Ceren, Yurdcu Esra, Yıldırım Umut, Güriz Haluk, Bozdayı Gülendam, Yurdaydın Cihan, İlhan Osman, Yıldırım Yasin, Hdv Study Group Motakk Hcv Genotype And, Bozdayı A Mithat

机构信息

Hepatology Institute, Ankara University, Ankara, Turkey.

Biotechnology Institute, Ankara University, Ankara, Turkey.

出版信息

Turk J Gastroenterol. 2019 Nov;30(11):957-963. doi: 10.5152/tjg.2019.18859.

DOI:10.5152/tjg.2019.18859

PMID:31767550

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6883996/

Abstract

BACKGROUND/AIMS: To evaluate the HCV RNA genotyping and HDV RNA tests that are performed in molecular microbiology laboratories in Turkey as part of a national external quality assessment programme, MOTAKK (Moleküler Tanıda Kalite Kontrol) (English translation: Quality control in molecular diagnostics).

MATERIALS AND METHODS

Plasmas having different HCV RNA genotypes were used to prepare HCV genotype control sera. The HDV RNA main stock was prepared from patients with chronic delta hepatitis who had a significant amount of viral load detected, as per the WHO reference materials on viral load studies that were compiled for the purpose of developing HDV RNA control sera. Samples with different viral loads were prepared from this main stock by dilution. The prepared controls were delivered to the registered laboratories. The laboratories carried out the relevant tests and entered their results via the MOTAKK web page. External quality assessment (EQA) reports of the participants were uploaded to the website as well.

RESULTS

In total, there were 23 participating laboratories, out of which 20 exclusively performed HCV genotyping, and 15 and 16 only performed HDV RNA in 2015 and 2016, respectively. The success rate of the results of the HCV genotype was 56-96% in 2015 and 30-95% in 2016. The tube with a 30% success rate had a recombinant type of HCV, therefore, it could not be detected in most of the laboratories. The HDV RNA results were evaluated qualitatively. Accordingly, HDV RNA detection rates of participant laboratories were 71-100% in 2015 and 50-100% in 2016.

CONCLUSION

This study was the first national external quality control program in Turkey regarding HCV RNA genotyping and HDV RNA in the field of molecular microbiology, and it was implemented successfully.

摘要

背景/目的：在土耳其，作为全国性外部质量评估计划MOTAKK（分子诊断质量控制）的一部分，对分子微生物实验室开展的丙型肝炎病毒（HCV）RNA基因分型和丁型肝炎病毒（HDV）RNA检测进行评估。

材料与方法

使用具有不同HCV RNA基因型的血浆制备HCV基因型对照血清。HDV RNA主储备液取自慢性丁型肝炎患者，这些患者根据世界卫生组织为开发HDV RNA对照血清而编制的病毒载量研究参考材料，检测到大量病毒载量。通过稀释从该主储备液制备具有不同病毒载量的样本。将制备好的对照品分发给注册实验室。实验室进行相关检测，并通过MOTAKK网页输入结果。参与者的外部质量评估（EQA）报告也上传至网站。

结果

共有23个参与实验室，其中20个专门进行HCV基因分型，2015年和2016年分别有15个和16个仅进行HDV RNA检测。2015年HCV基因型检测结果的成功率为56% - 96%，2016年为30% - 95%。成功率为30%的样本管含有重组型HCV，因此在大多数实验室中无法检测到。HDV RNA结果进行定性评估。据此，参与实验室的HDV RNA检测率在2015年为71% - 100%，2016年为50% - 100%。