Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance
Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×102 TCID50/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:47 |
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| Enthalten in: |
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation - 47(2023), 1 vom: 30. Jan., Seite 99-105 |
| Sprache: |
Chinesisch |
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| Beteiligte Personen: |
Jiang, Xiaolu [VerfasserIn] |
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| Links: |
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| Themen: |
Analytical performance evaluation |
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| Anmerkungen: |
Date Completed 09.02.2023 Date Revised 09.02.2023 published: Print Citation Status MEDLINE |
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| doi: |
10.3969/j.issn.1671-7104.2023.01.018 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM352619325 |
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| 500 | |a Date Revised 09.02.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×102 TCID50/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus | ||
| 650 | 4 | |a English Abstract | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a analytical performance evaluation | |
| 650 | 4 | |a coronavirus infection | |
| 650 | 4 | |a in vitro diagnostics | |
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| 700 | 1 | |a Yang, Lancui |e verfasserin |4 aut | |
| 700 | 1 | |a Fan, Chenxia |e verfasserin |4 aut | |
| 700 | 1 | |a Zheng, Ming |e verfasserin |4 aut | |
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