Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR
Background: Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Previously, the accuracy of the quantitative LUMIPULSE SARS-CoV-2 antigen test was demonstrated using samples collected retrospecti...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-04-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971221000904 |
| _version_ | 1819076456212332544 |
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| author | Yosuke Hirotsu Makoto Maejima Masahiro Shibusawa Kenji Amemiya Yuki Nagakubo Kazuhiro Hosaka Hitomi Sueki Miyoko Hayakawa Hitoshi Mochizuki Toshiharu Tsutsui Yumiko Kakizaki Yoshihiro Miyashita Masao Omata |
| author_facet | Yosuke Hirotsu Makoto Maejima Masahiro Shibusawa Kenji Amemiya Yuki Nagakubo Kazuhiro Hosaka Hitomi Sueki Miyoko Hayakawa Hitoshi Mochizuki Toshiharu Tsutsui Yumiko Kakizaki Yoshihiro Miyashita Masao Omata |
| author_sort | Yosuke Hirotsu |
| collection | DOAJ |
| description | Background: Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Previously, the accuracy of the quantitative LUMIPULSE SARS-CoV-2 antigen test was demonstrated using samples collected retrospectively. In this study, the LUMIPULSE antigen test was clinically validated using prospective samples. Methods: In total, 1033 nasopharyngeal swab samples were collected from 1033 individuals, and an additional 275 follow-up samples were collected from 43 patients who subsequently tested positive for coronavirus disease 2019 (COVID-19). All 1308 samples were subjected to quantitative RT-PCR (RT-qPCR) and the antigen test. The antibody response was investigated for patients with discordant results to clarify if seroconversion had occurred. Results: RT-qPCR identified 990 samples as negative and 43 as positive, while the antigen test identified 992 samples as negative, 37 as positive and four as inconclusive. The overall concordance rate was 99.7% (1026/1029). Sensitivity, specificity, positive predictive value and negative predictive value of the antigen test were 92.5% (37/40), 100% (989/989), 100% (37/37) and 99.7% (989/992), respectively, after exclusion of the four inconclusive results. The kappa coefficient was 0.960 (95% confidence interval 0.892–0.960), suggesting excellent agreement between the two tests. Seropositivity in five of seven patients with discordant results suggested that the discrepancy was caused by samples collected during the late phase of infection. Using follow-up samples, correlation was observed between the antigen level and the viral load or cycle threshold value. The concordance rate between these test results tended to be high among samples collected 0–9 days after symptom onset, but this decreased gradually in samples collected thereafter. Conclusions: This prospective study demonstrated that the LUMIPULSE antigen test is a highly accurate diagnostic test for SARS-CoV-2. |
| first_indexed | 2024-12-21T18:41:35Z |
| format | Article |
| id | doaj.art-06418e91b57644daaf24809c6a9d1306 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-21T18:41:35Z |
| publishDate | 2021-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-06418e91b57644daaf24809c6a9d13062022-12-21T18:54:00ZengElsevierInternational Journal of Infectious Diseases1201-97122021-04-01105714Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCRYosuke Hirotsu0Makoto Maejima1Masahiro Shibusawa2Kenji Amemiya3Yuki Nagakubo4Kazuhiro Hosaka5Hitomi Sueki6Miyoko Hayakawa7Hitoshi Mochizuki8Toshiharu Tsutsui9Yumiko Kakizaki10Yoshihiro Miyashita11Masao Omata12Genome Analysis Centre, Yamanashi Central Hospital, Kofu, Yamanashi, Japan; Corresponding author at: Genome Analysis Centre, Yamanashi Central Hospital, 1-1-1 Fujimi, Kofu, Yamanashi, Japan.Division of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, JapanDivision of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, JapanDivision of Genetics and Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, JapanDivision of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan; Division of Genetics and Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, JapanDivision of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, JapanDivision of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, JapanCentral Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, JapanGenome Analysis Centre, Yamanashi Central Hospital, Kofu, Yamanashi, Japan; Central Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan; Department of Gastroenterology, Yamanashi Central Hospital, Kofu, Yamanashi, JapanLung Cancer and Respiratory Disease Centre, Yamanashi Central Hospital, Kofu, Yamanashi, JapanLung Cancer and Respiratory Disease Centre, Yamanashi Central Hospital, Kofu, Yamanashi, JapanLung Cancer and Respiratory Disease Centre, Yamanashi Central Hospital, Kofu, Yamanashi, JapanDepartment of Gastroenterology, Yamanashi Central Hospital, Kofu, Yamanashi, Japan; The University of Tokyo, Bunkyo-ku, Tokyo, JapanBackground: Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Previously, the accuracy of the quantitative LUMIPULSE SARS-CoV-2 antigen test was demonstrated using samples collected retrospectively. In this study, the LUMIPULSE antigen test was clinically validated using prospective samples. Methods: In total, 1033 nasopharyngeal swab samples were collected from 1033 individuals, and an additional 275 follow-up samples were collected from 43 patients who subsequently tested positive for coronavirus disease 2019 (COVID-19). All 1308 samples were subjected to quantitative RT-PCR (RT-qPCR) and the antigen test. The antibody response was investigated for patients with discordant results to clarify if seroconversion had occurred. Results: RT-qPCR identified 990 samples as negative and 43 as positive, while the antigen test identified 992 samples as negative, 37 as positive and four as inconclusive. The overall concordance rate was 99.7% (1026/1029). Sensitivity, specificity, positive predictive value and negative predictive value of the antigen test were 92.5% (37/40), 100% (989/989), 100% (37/37) and 99.7% (989/992), respectively, after exclusion of the four inconclusive results. The kappa coefficient was 0.960 (95% confidence interval 0.892–0.960), suggesting excellent agreement between the two tests. Seropositivity in five of seven patients with discordant results suggested that the discrepancy was caused by samples collected during the late phase of infection. Using follow-up samples, correlation was observed between the antigen level and the viral load or cycle threshold value. The concordance rate between these test results tended to be high among samples collected 0–9 days after symptom onset, but this decreased gradually in samples collected thereafter. Conclusions: This prospective study demonstrated that the LUMIPULSE antigen test is a highly accurate diagnostic test for SARS-CoV-2.http://www.sciencedirect.com/science/article/pii/S1201971221000904SARS-CoV-2COVID-19AntigenRT-qPCRLUMIPULSE |
| spellingShingle | Yosuke Hirotsu Makoto Maejima Masahiro Shibusawa Kenji Amemiya Yuki Nagakubo Kazuhiro Hosaka Hitomi Sueki Miyoko Hayakawa Hitoshi Mochizuki Toshiharu Tsutsui Yumiko Kakizaki Yoshihiro Miyashita Masao Omata Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR International Journal of Infectious Diseases SARS-CoV-2 COVID-19 Antigen RT-qPCR LUMIPULSE |
| title | Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR |
| title_full | Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR |
| title_fullStr | Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR |
| title_full_unstemmed | Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR |
| title_short | Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR |
| title_sort | prospective study of 1308 nasopharyngeal swabs from 1033 patients using the lumipulse sars cov 2 antigen test comparison with rt qpcr |
| topic | SARS-CoV-2 COVID-19 Antigen RT-qPCR LUMIPULSE |
| url | http://www.sciencedirect.com/science/article/pii/S1201971221000904 |
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