Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection
The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to unprecedented social and economic disruption. Many nucleic acid testing (NAT) laboratories in China have been established to control the epidemic better. This proficiency testing (PT) aims to evaluate the...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-10-01
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| Series: | Biosafety and Health |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590053622001276 |
| _version_ | 1811197299811942400 |
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| author | Yongzhuo Zhang Xia Wang Chunyan Niu Di Wang Qingfei Shen Yunhua Gao Haiwei Zhou Yujing Zhang Yan Zhang Lianhua Dong |
| author_facet | Yongzhuo Zhang Xia Wang Chunyan Niu Di Wang Qingfei Shen Yunhua Gao Haiwei Zhou Yujing Zhang Yan Zhang Lianhua Dong |
| author_sort | Yongzhuo Zhang |
| collection | DOAJ |
| description | The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to unprecedented social and economic disruption. Many nucleic acid testing (NAT) laboratories in China have been established to control the epidemic better. This proficiency testing (PT) aims to evaluate the participants’ performance in qualitative and quantitative SARS-CoV-2 NAT and to explore the factors that contribute to differences in detection capabilities. Two different concentrations of RNA samples (A, B) were used for quantitative PT. Pseudovirus samples D, E (different concentrations) and negative sample (F) were used for qualitative PT. 50 data sets were reported for qualitative PT, of which 74.00% were entirely correct for all samples. Forty-two laboratories participated in the quantitative PT. 37 submitted all gene results, of which only 56.76% were satisfactory. For qualitative detection, it is suggested that laboratories should strengthen personnel training, select qualified detection kits, and reduce cross-contamination to improve detection accuracy. For quantitative detection, the results of the reverse transcription digital PCR (RT-dPCR) method were more comparable and reliable than those of reverse transcription quantitative PCR (RT-qPCR). The copy number concentration of ORF1ab and N in samples A and B scattered in 85, 223, 50, and 106 folds, respectively. The differences in the quantitative result of RT-qPCR was mainly caused by the non-standard use of reference materials and the lack of personnel operating skills. Comparing the satisfaction of participants participating in both quantitative and qualitative proficiency testing, 95.65% of the laboratories with satisfactory quantitative results also judged the qualitative results correctly, while 85.71% of the laboratories with unsatisfactory quantitative results were also unsatisfied with their qualitative judgments. Therefore, the quantitative ability is the basis of qualitative judgment. Overall, participants from hospitals reported more satisfactory results than those from enterprises and universities. Therefore, surveillance, daily qualitiy control and standardized operating procedures should be strengthened to improve the capability of SARS-CoV-2 NAT. |
| first_indexed | 2024-04-12T01:12:53Z |
| format | Article |
| id | doaj.art-0b298360411f476c8689a7430065945b |
| institution | Directory Open Access Journal |
| issn | 2590-0536 |
| language | English |
| last_indexed | 2024-04-12T01:12:53Z |
| publishDate | 2022-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Biosafety and Health |
| spelling | doaj.art-0b298360411f476c8689a7430065945b2022-12-22T03:54:03ZengElsevierBiosafety and Health2590-05362022-10-0145321329Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detectionYongzhuo Zhang0Xia Wang1Chunyan Niu2Di Wang3Qingfei Shen4Yunhua Gao5Haiwei Zhou6Yujing Zhang7Yan Zhang8Lianhua Dong9National Institute of Metrology, Beijing 100029, ChinaNational Institute of Metrology, Beijing 100029, ChinaNational Institute of Metrology, Beijing 100029, ChinaNational Institute of Metrology, Beijing 100029, ChinaNational Institute of Metrology, Beijing 100029, ChinaNational Institute of Metrology, Beijing 100029, ChinaDivision II of In Vitro Diagnostics for Infectious Diseases, Institute for In Vitro Diagnostics Control, National Institutes for Food and Drug Control, Beijing 100050, ChinaNational Institute of Metrology, Beijing 100029, ChinaNational Institute of Metrology, Beijing 100029, ChinaNational Institute of Metrology, Beijing 100029, China; Corresponding author: Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China.The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to unprecedented social and economic disruption. Many nucleic acid testing (NAT) laboratories in China have been established to control the epidemic better. This proficiency testing (PT) aims to evaluate the participants’ performance in qualitative and quantitative SARS-CoV-2 NAT and to explore the factors that contribute to differences in detection capabilities. Two different concentrations of RNA samples (A, B) were used for quantitative PT. Pseudovirus samples D, E (different concentrations) and negative sample (F) were used for qualitative PT. 50 data sets were reported for qualitative PT, of which 74.00% were entirely correct for all samples. Forty-two laboratories participated in the quantitative PT. 37 submitted all gene results, of which only 56.76% were satisfactory. For qualitative detection, it is suggested that laboratories should strengthen personnel training, select qualified detection kits, and reduce cross-contamination to improve detection accuracy. For quantitative detection, the results of the reverse transcription digital PCR (RT-dPCR) method were more comparable and reliable than those of reverse transcription quantitative PCR (RT-qPCR). The copy number concentration of ORF1ab and N in samples A and B scattered in 85, 223, 50, and 106 folds, respectively. The differences in the quantitative result of RT-qPCR was mainly caused by the non-standard use of reference materials and the lack of personnel operating skills. Comparing the satisfaction of participants participating in both quantitative and qualitative proficiency testing, 95.65% of the laboratories with satisfactory quantitative results also judged the qualitative results correctly, while 85.71% of the laboratories with unsatisfactory quantitative results were also unsatisfied with their qualitative judgments. Therefore, the quantitative ability is the basis of qualitative judgment. Overall, participants from hospitals reported more satisfactory results than those from enterprises and universities. Therefore, surveillance, daily qualitiy control and standardized operating procedures should be strengthened to improve the capability of SARS-CoV-2 NAT.http://www.sciencedirect.com/science/article/pii/S2590053622001276Proficiency testingSARS-CoV-2Nucleic acid testingReference materialQuality assessmentPseudovirus |
| spellingShingle | Yongzhuo Zhang Xia Wang Chunyan Niu Di Wang Qingfei Shen Yunhua Gao Haiwei Zhou Yujing Zhang Yan Zhang Lianhua Dong Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection Biosafety and Health Proficiency testing SARS-CoV-2 Nucleic acid testing Reference material Quality assessment Pseudovirus |
| title | Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection |
| title_full | Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection |
| title_fullStr | Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection |
| title_full_unstemmed | Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection |
| title_short | Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection |
| title_sort | evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for sars cov 2 nucleic acid detection |
| topic | Proficiency testing SARS-CoV-2 Nucleic acid testing Reference material Quality assessment Pseudovirus |
| url | http://www.sciencedirect.com/science/article/pii/S2590053622001276 |
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