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Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparison with RT-qPCR.
Hirotsu, Yosuke; Maejima, Makoto; Shibusawa, Masahiro; Amemiya, Kenji; Nagakubo, Yuki; Hosaka, Kazuhiro; Sueki, Hitomi; Hayakawa, Miyoko; Mochizuki, Hitoshi; Tsutsui, Toshiharu; Kakizaki, Yumiko; Miyashita, Yoshihiro; Omata, Masao.
  • Hirotsu Y; Genome Analysis Centre, Yamanashi Central Hospital, Kofu, Yamanashi, Japan. Electronic address: hirotsu-bdyu@ych.pref.yamanashi.jp.
  • Maejima M; Division of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Shibusawa M; Division of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Amemiya K; Division of Genetics and Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Nagakubo Y; Division of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan; Division of Genetics and Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Hosaka K; Division of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Sueki H; Division of Microbiology in Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Hayakawa M; Central Clinical Laboratory, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Mochizuki H; Genome 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, Japan.
  • Tsutsui T; Lung Cancer and Respiratory Disease Centre, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Kakizaki Y; Lung Cancer and Respiratory Disease Centre, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Miyashita Y; Lung Cancer and Respiratory Disease Centre, Yamanashi Central Hospital, Kofu, Yamanashi, Japan.
  • Omata M; Department of Gastroenterology, Yamanashi Central Hospital, Kofu, Yamanashi, Japan; The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Int J Infect Dis ; 105: 7-14, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1152369
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Nasopharynx / COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Nasopharynx / COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article