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Development of an Automated Chemiluminescence Assay System for Quantitative Measurement of Multiple Anti-SARS-CoV-2 Antibodies.
Kubo, Sousuke; Ohtake, Norihisa; Miyakawa, Kei; Jeremiah, Sundararaj Stanleyraj; Yamaoka, Yutaro; Murohashi, Kota; Hagiwara, Eri; Mihara, Takahiro; Goto, Atsushi; Yamazaki, Etsuko; Ogura, Takashi; Kaneko, Takeshi; Yamanaka, Takeharu; Ryo, Akihide.
  • Kubo S; Department of Microbiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
  • Ohtake N; Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
  • Miyakawa K; Bioscience Division, Reagent Development Department, Tosoh Corporation, Kanagawa, Japan.
  • Jeremiah SS; Advanced Medical Research Center, Yokohama City University, Yokohama, Japan.
  • Yamaoka Y; Department of Microbiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
  • Murohashi K; Department of Microbiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
  • Hagiwara E; Department of Microbiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
  • Mihara T; Life Science Laboratory, Technology and Development Division, Kanto Chemical Co., Inc., Kanagawa, Japan.
  • Goto A; Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
  • Yamazaki E; Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
  • Ogura T; Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
  • Kaneko T; Department of Health Data Science, Yokohama City University Graduate School of Data Science, Yokohama, Japan.
  • Yamanaka T; Department of Health Data Science, Yokohama City University Graduate School of Data Science, Yokohama, Japan.
  • Ryo A; Clinical Laboratory Department, Yokohama City University Hospital, Yokohama, Japan.
Front Microbiol ; 11: 628281, 2020.
Article in English | MEDLINE | ID: covidwho-1058428
Preprint
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Semantic information from SemMedBD (by NLM)
1. Serologic tests DIAGNOSES COVID-19
Subject
Serologic tests
Predicate
DIAGNOSES
Object
COVID-19
2. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
3. Serologic tests DIAGNOSES COVID-19
Subject
Serologic tests
Predicate
DIAGNOSES
Object
COVID-19
4. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
ABSTRACT

Objectives:

Serological tests for COVID-19 have been instrumental in studying the epidemiology of the disease. However, the performance of the currently available tests is plagued by the problem of variability. We have developed a high-throughput serological test capable of simultaneously detecting total immunoglobulins (Ig) and immunoglobulin G (IgG) against nucleocapsid protein (NP) and spike protein (SP) and report its performance in detecting COVID-19 in clinical samples.

Methods:

We designed and prepared reagents for measuring NP-IgG, NP-Total Ig, SP-IgG, and SP-Total Ig (using N-terminally truncated NP (ΔN-NP) or receptor-binding domain (RBD) antigen) dedicated automated chemiluminescent enzyme immunoassay analyzer AIA-CL1200. After determining the basal thresholds based on 17 sera obtained from confirmed COVID-19 patients and 600 negative sera, the clinical validity of the assay was evaluated using independent 202 positive samples and 1,000 negative samples from healthy donors.

Results:

All of the four test parameters showed 100% specificity individually (1,000/1,000; 95%CI, 99.63-100). The sensitivity of the assay increased proportionally to the elapsed time from symptoms onset, and all the tests achieved 100% sensitivity (153/153; 95%CI, 97.63-100) after 13 days from symptoms onset. NP-Total Ig was the earliest to attain maximal sensitivity among the other antibodies tested.

Conclusion:

Our newly developed serological testing exhibited 100% sensitivity and specificity after 13 days from symptoms onset. Hence, it could be used as a reliable method for accurate detection of COVID-19 patients and to evaluate seroprevalence and possibly for surrogate assessment of herd immunity.
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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Language: English Journal: Front Microbiol Year: 2020

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Language: English Journal: Front Microbiol Year: 2020
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