The current status and construction of evaluation index list for the performance of diagnostic reagents in systematic reviews_Chinese Journal of Evidence-Based Medicine

Authors：

DIAO Sha ^1,2,3,4 , HE Siyi ^1,2,3,4,5 , LIU Zheng ^1,2,3,4,6 , CHEN Zhe ^1,2,3,4 , CHENG Xiao ^1,2,3,4 , NI Xiaofeng ^1,2,3,4 , ZENG Linan ^1,2,3,4 , YING Binwu ⁷ , ZHAO Rongsheng ⁸ ,  ZHANG Lingli ^1,2,3,4,9

1. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. Evidence-based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. NMPA Key Laboratory for Technical Research on Drug Products in vitro and in vivo Correlation, Chengdu 610041, P. R. China;
4. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu 610041, P. R. China;
5. West China School of Pharmacy, Sichuan University, Chengdu 610041, P. R. China;
6. West China School of Medicine, Sichuan University, Chengdu 610041, P. R. China;
7. Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
8. Department of Pharmacy, Peking University Third Hospital, Beijing 100191, P. R. China;
9. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

ZHANG Lingli, Email: zhanglingli@scu.edu.cn

Keywords：

Diagnostic reagents; Systematic reviews; Performance; Evaluation index

DOI：

10.7507/1672-2531.202308084

Video：

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Objective To describe the current status of evaluation index for the performance of diagnostic reagents compared with gold standards in systematic reviews, and develop the list of evaluation index. Methods PubMed, Embase (OVID), Cochrane Library (OVID), CBM, WanFang Data and CNKI databases were searched for systematic reviews about the performance of diagnostic reagents compared with gold standards from inception to 28^th April, 2023. Two reviewers independently screened literature and extracted data. The frequency and ratio were used to describe the current status, while the qualitative synthesis was used to develop the list. Results A total of 133 systematic reviews were included. Sensitivity (133/133, 100.0%), specificity (131/133, 98.5%) and AUC (80/133, 60.2%) were used more frequently than 50%. Q index (6/133, 4.5%), false positive rate (3/133, 2.3%), Kappa value (2/133, 1.5%), false negative rate (1/133, 5%) and Youden's index were used less frequently than 5%. In order to evaluate the performance of diagnostic reagents compared with gold standards in systematic reviews comprehensively, a total of 14 index related to validity and predictability could be considered. Conclusion The evaluation index for the performance of diagnostic reagents in systematic reviews are inconsistent and limited, so there is an urgent need to develop standardized evaluation indicators based on expert consensus.

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