Evaluate performance of the Abbott chemiluminescent microparticle immunoassay assay for detection of syphilis infection in Chinese blood donors

Autor: Jian‐fang Liu, Ling Ke, Xiao‐ting Lv, Yu Liu, Sushil Devare, Peng Yin, Bingting Wu, Hua Shan, Ping Fu
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Microbiology (medical)
medicine.medical_specialty
China
Blood transfusion
medicine.medical_treatment
Clinical Biochemistry
syphilis
Blood Donors
Syphilis infection
Gastroenterology
law.invention
03 medical and health sciences
0302 clinical medicine
Asian People
law
Internal medicine
medicine
Immunology and Allergy
Humans
Mass Screening
Treponema pallidum
Research Articles
Chemiluminescence
Immunoassay
Treponema
medicine.diagnostic_test
biology
business.industry
Biochemistry (medical)
Public Health
Environmental and Occupational Health
Hematology
medicine.disease
biology.organism_classification
Syphilis Serodiagnosis
Medical Laboratory Technology
030104 developmental biology
Blood donor
030220 oncology & carcinogenesis
Luminescent Measurements
Syphilis
CMIA
business
Treponema pallidum particle agglutination assay
Research Article
Zdroj: Journal of Clinical Laboratory Analysis
ISSN: 1098-2825
0887-8013
Popis: Background and Objectives To prevent Treponema Pallidum (TP) transmission from blood transfusion, enzyme‐linked immunosorbent assay (EIA) for anti‐TP has been widely used in routine blood donation screening in China for many years. The aim of this study was to evaluate the performance of the Abbott CMIA assay for detection of anti‐TP in Chinese blood donors. Materials and methods A total of 2420 plasma samples, already routinely screened for anti‐TP by two different EIAs, from four blood Centers were tested for anti‐TP by Abbott CMIA. Subsequently, all samples with positive results by one or both EIAs and/or by Abbott CMIA were subjected to confirmatory testing (CT) using recombinant immunoblot assay (RIBA) or Treponema Pallidum particle agglutination assay (TPPA). TP infection was defined by a RIBA or TPPA positive. Results Compared with two EIAs strategy, Abbott CMIA showed a relatively best sensitivity as 98.80% (95% CI: 97.44%‐100.16%) and a relatively best specificity as 99.58% (95% CI: 99.30%‐99.85%), yielding the best consistency (99.49%) between anti‐TP CT results with the highest κ value of .98. Conclusion This is the first study to evaluate the performance of the Abbott CMIA assays for detection of syphilis in Chinese blood donors. Our results suggested that CMIA performed better than both EIAs, and implementation of CMIA replacing two different EIA reagents might help to further reduce the risk of transfusion‐transmitted TP infection, decrease unnecessary blood waste and loss of blood donors.
Databáze: OpenAIRE
Externí odkaz: