tetano
Editor, Senior Moderator
Clin Chem Lab Med
. 2023 Jun 29.
doi: 10.1515/cclm-2023-0597. Online ahead of print. Performance evaluation of SARS-CoV-2 antigen detection in the post-pandemic era: multi-laboratory assessment
Yuqing Chen[SUP] 1 2 3 [/SUP], Lei Feng[SUP] 1 2 3 [/SUP], Yanxi Han[SUP] 1 3 [/SUP], Zihong Zhao[SUP] 1 3 4 [/SUP], Zhenli Diao[SUP] 1 2 3 [/SUP], Tao Huang[SUP] 1 2 3 [/SUP], Yu Ma[SUP] 1 2 3 [/SUP], Wanyu Feng[SUP] 1 2 3 [/SUP], Jing Li[SUP] 1 2 3 [/SUP], Ziqiang Li[SUP] 1 2 3 [/SUP], Cong Liu[SUP] 1 2 3 [/SUP], Lu Chang[SUP] 1 2 3 [/SUP], Jinming Li[SUP] 1 2 3 5 [/SUP], Rui Zhang[SUP] 1 2 3 5 [/SUP]
Affiliations
Objectives: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection is an indispensable tool for epidemic surveillance in the post-pandemic era. Faced with irregular performance, a comprehensive external quality assessment (EQA) scheme was conducted by the National Center for Clinical Laboratories (NCCL) to evaluate the analytical performance and status of SARS-CoV-2 antigen tests.
Methods: The EQA panel included ten lyophilized samples containing serial 5-fold dilutions of inactivated SARS-CoV-2-positive supernatants of the Omicron BA.1 and BA.5 strains and negative samples, which were classified into "validating" samples and "educational" samples. Data were analyzed according to qualitative results for each sample.
Results: A total of 339 laboratories in China participated in this EQA scheme, and 378 effective results were collected. All validating samples were correctly reported by 90.56 % (307/339) of the participants and 90.21 % (341/378) of the datasets. The positive percent agreement (PPA) was >99 % for samples with concentrations of 2 × 10[SUP]7[/SUP] copies/mL but was 92.20 % (697/756) for 4 × 10[SUP]6[/SUP] copies/mL and 25.26 % (382/1,512) for 8 × 10[SUP]5[/SUP] copies/mL samples. Colloidal gold was the most frequently used (84.66 %, 320/378) but showed the lowest PPAs (57.11 %, 1,462/2,560) for positive samples compared with fluorescence immunochromatography (90 %, 36/40) and latex chromatography (79.01 %, 335/424). Among 11 assays used in more than 10 clinical laboratories, ACON showed a higher sensitivity than other assays.
Conclusions: The EQA study can help to validate whether it's necessary to update antigen detection assays for manufacturers and provide participants with information about the performance of assays to take the first step toward routine post-market surveillance.
Keywords: SARS-CoV-2 antigen detection; analytical performance; external quality assessment; inconsistency; positive percent agreement.
. 2023 Jun 29.
doi: 10.1515/cclm-2023-0597. Online ahead of print. Performance evaluation of SARS-CoV-2 antigen detection in the post-pandemic era: multi-laboratory assessment
Yuqing Chen[SUP] 1 2 3 [/SUP], Lei Feng[SUP] 1 2 3 [/SUP], Yanxi Han[SUP] 1 3 [/SUP], Zihong Zhao[SUP] 1 3 4 [/SUP], Zhenli Diao[SUP] 1 2 3 [/SUP], Tao Huang[SUP] 1 2 3 [/SUP], Yu Ma[SUP] 1 2 3 [/SUP], Wanyu Feng[SUP] 1 2 3 [/SUP], Jing Li[SUP] 1 2 3 [/SUP], Ziqiang Li[SUP] 1 2 3 [/SUP], Cong Liu[SUP] 1 2 3 [/SUP], Lu Chang[SUP] 1 2 3 [/SUP], Jinming Li[SUP] 1 2 3 5 [/SUP], Rui Zhang[SUP] 1 2 3 5 [/SUP]
Affiliations
- PMID: 37377068
- DOI: 10.1515/cclm-2023-0597
Objectives: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection is an indispensable tool for epidemic surveillance in the post-pandemic era. Faced with irregular performance, a comprehensive external quality assessment (EQA) scheme was conducted by the National Center for Clinical Laboratories (NCCL) to evaluate the analytical performance and status of SARS-CoV-2 antigen tests.
Methods: The EQA panel included ten lyophilized samples containing serial 5-fold dilutions of inactivated SARS-CoV-2-positive supernatants of the Omicron BA.1 and BA.5 strains and negative samples, which were classified into "validating" samples and "educational" samples. Data were analyzed according to qualitative results for each sample.
Results: A total of 339 laboratories in China participated in this EQA scheme, and 378 effective results were collected. All validating samples were correctly reported by 90.56 % (307/339) of the participants and 90.21 % (341/378) of the datasets. The positive percent agreement (PPA) was >99 % for samples with concentrations of 2 × 10[SUP]7[/SUP] copies/mL but was 92.20 % (697/756) for 4 × 10[SUP]6[/SUP] copies/mL and 25.26 % (382/1,512) for 8 × 10[SUP]5[/SUP] copies/mL samples. Colloidal gold was the most frequently used (84.66 %, 320/378) but showed the lowest PPAs (57.11 %, 1,462/2,560) for positive samples compared with fluorescence immunochromatography (90 %, 36/40) and latex chromatography (79.01 %, 335/424). Among 11 assays used in more than 10 clinical laboratories, ACON showed a higher sensitivity than other assays.
Conclusions: The EQA study can help to validate whether it's necessary to update antigen detection assays for manufacturers and provide participants with information about the performance of assays to take the first step toward routine post-market surveillance.
Keywords: SARS-CoV-2 antigen detection; analytical performance; external quality assessment; inconsistency; positive percent agreement.