Evaluation of eight anti-rubella virus immunoglobulin G immunoassays that report results in international units per milliliter

被引:40
作者
Dimech, Wayne [1 ]
Panagiotopoulos, Lena [1 ]
Francis, Barbara [1 ]
Laven, Nicholas [2 ]
Marler, Joan [2 ]
Dickeson, David [3 ]
Panayotou, Tony [4 ]
Wilson, Kim [1 ]
Wootten, Robyn [2 ]
Dax, Elizabeth M. [1 ,5 ]
机构
[1] St Vincents Inst, Natl Serol Reference Lab, Fitzroy, Vic 3065, Australia
[2] Dorevitch Pathol, Symb Hlth, Dept Serol, Heidelberg, Vic 3084, Australia
[3] Westmead Hosp, Ctr Infect Dis & Microbiol, Inst Clin Pathol & Med Res, Lab Serv, Westmead, NSW 2145, Australia
[4] So Hlth, Dept Microbiol, Clayton, Vic 3168, Australia
[5] Univ Melbourne, Dept Microbiol & Immunol, Parkville, Vic 3052, Australia
关键词
D O I
10.1128/JCM.00231-08
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
An evaluation of anti-rubella virus immunoglobulin G (IgG) immunoassays that report in international units per milliliter (IU/ml) was performed to determine their analytical performance and the degree of correlation of the test results. A total of 321 samples were characterized based on results from a hemagglutination inhibition assay. The 48 negative and 273 positive samples were used to determine the sensitivity and specificity of the assays. When equivocal results were interpreted as reactive, the sensitivity of the immunoassays ranged from 98.9 to 99.9% and the specificity ranged from 77.1 to 95.8%. All assays had positive and negative delta values of less than 2. A significant difference between the mean results of all assays was demonstrated by analysis of variance. However, post hoc analysis showed there was good correlation in the mean results expressed in IU/ml between some of the assays. Our results show the level of standardization between anti-rubella virus IgG immunoassays reporting results expressed as IU/ml has improved since a previous study in 1992, but further improvement is required.
引用
收藏
页码:1955 / 1960
页数:6
相关论文
共 32 条
[1]   Lesson of the week - Interpretation of rubella serology in pregnancy - pitfalls and problems [J].
Best, JM ;
O'Shea, S ;
Tipples, G ;
Davies, N ;
Al-Khusaiby, SM ;
Krause, A ;
Hesketh, LM ;
Jin, L ;
Enders, G .
BRITISH MEDICAL JOURNAL, 2002, 325 (7356) :147-148
[2]  
BEST JM, 2007, RUBELLA SEMIN FETAL, V12, P182
[3]   LABORATORY DIAGNOSIS OF RUBELLA - PAST, PRESENT AND FUTURE [J].
CRADOCKWATSON, JE .
EPIDEMIOLOGY AND INFECTION, 1991, 107 (01) :1-15
[4]   EVALUATION OF ENZYME-LINKED IMMUNOSORBENT ASSAYS - A METHOD OF DATA-ANALYSIS [J].
CROFTS, N ;
MASKILL, W ;
GUST, ID .
JOURNAL OF VIROLOGICAL METHODS, 1988, 22 (01) :51-59
[5]   European performance evaluations of the ADVIA Centaur® infectious disease assays:: requirements for performance evaluation according to the European directive on in vitro diagnostics [J].
Dati, F ;
Denoyel, G ;
van Helden, J .
JOURNAL OF CLINICAL VIROLOGY, 2004, 30 :S6-S10
[6]  
Dati Francesco, 2004, Clin Lab, V50, P53
[7]   Antenatal screening for hepatitis B and antibodies to Toxoplasma gondii and rubella virus:: Evaluation of two commercial immunoassay systems [J].
Diepersloot, RJA ;
Dunnewold-Hoekstra, H ;
Kruit-Den Hollander, J ;
Vlaspolder, F .
CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, 2001, 8 (04) :785-787
[8]   MULTICENTER EVALUATION OF 5 COMMERCIAL RUBELLA-VIRUS IMMUNOGLOBULIN-G KITS WHICH REPORT IN INTERNATIONAL UNITS PER MILLILITER [J].
DIMECH, W ;
BETTOLI, A ;
ECKERT, D ;
FRANCIS, B ;
HAMBLIN, J ;
KERR, T ;
RYAN, C ;
SKURRIE, I .
JOURNAL OF CLINICAL MICROBIOLOGY, 1992, 30 (03) :633-641
[9]   RUBELLA SCREENING AND VACCINATION PROGRAM AT A MELBOURNE MATERNITY HOSPITAL - A 5-YEAR REVIEW [J].
FRANCIS, BH ;
HATHERLEY, LI ;
WALSTAB, JE ;
TAFT, LI .
MEDICAL JOURNAL OF AUSTRALIA, 1982, 1 (12) :502-504
[10]   The impact of rubella immunization on the serological status of women of childbearing age: A retrospective longitudinal study in Melbourne, Australia [J].
Francis, BH ;
Thomas, AK ;
McCarty, CA .
AMERICAN JOURNAL OF PUBLIC HEALTH, 2003, 93 (08) :1274-1276