Investigation of the performance of serological assays used for Lyme disease testing in Australia

被引:3
作者
Best, Susan J. [1 ]
Tschaepe, Marlene I. [1 ]
Wilson, Kim M. [1 ]
机构
[1] Div St Vincents Inst Med Res, Natl Serol Reference Lab, Melbourne, Vic, Australia
来源
PLOS ONE | 2019年 / 14卷 / 04期
关键词
BORRELIA-BURGDORFERI; ENZYME-IMMUNOASSAY; ANTIBODY-RESPONSES; SCREENING-TESTS; GENOMIC GROUPS; DIAGNOSIS; GUIDELINES; SERUM; VLSE; TICK;
D O I
10.1371/journal.pone.0214402
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
Spirochaetes of the Borrelia burgdorferi sensu lato complex, which includes those that cause Lyme disease, have not been identified in Australia. Nevertheless, Australian patients exist, some of whom have not left the country, who have symptoms consistent with so-called "chronic Lyme disease". Blood specimens from these individuals may be tested in Australian laboratories and in specialist laboratories outside Australia and sometimes conflicting results are obtained. Such discrepancies cause the patients to question the results from the Australian laboratories and seek assistance from the Australian Government in clarifying why the discrepancies occur. The aim of this study was to determine the level of agreement in results between commonly used B. burgdorferi serology assays in specimens of known status, and between results reported by different laboratories when they use the same serology assay. Five immunoassays and five immunoblots used in Australia and elsewhere were examined for the detection of IgG antibodies to Borrelia burgdorferi sensu lato. Predominantly, archived specimens previously tested for Lyme disease were used for the study and included 639 contributed by seven clinical laboratories located either in Australia or in areas endemic for Lyme disease. Also included were 308 prospectively collected Australian blood donor specimens. All clinical specimens were tested in all 10 assays whereas blood donor specimens were tested in all immunoassays and a subset was tested on immunoblots. With the exception of one immunoblot, the results between the assays agreed with each other in a known positive specimen population. 77% of the time and in a known negative population, 88% of the time or greater. The test results obtained during the study were different from the participating laboratory's less than 2% of the time when the same assay was used. These findings suggest that discordance in results between laboratories is more likely due to variation in algorithms or in the use of assays with different sensitivities or specificities rather than conflicting results being reported from the same assay in different laboratories. In the known negative population, specificities of the immunoassays ranged between 87.7% and 99.7%. In Australia's low prevalence population, this would translate to a positive predictive value of < 4%.
引用
收藏
页数:17
相关论文
共 32 条
[1]  
AgueroRosenfeld ME, 1996, J CLIN MICROBIOL, V34, P1
[2]  
Ang CW, 2011, EUR J CLIN MICROBIOL, V30, P1027, DOI 10.1007/s10096-011-1157-6
[3]   Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease [J].
Branda, John A. ;
Strle, Klemen ;
Nigrovic, Lise E. ;
Lantos, Paul M. ;
Lepore, Timothy J. ;
Damle, Nitin S. ;
Ferraro, Mary Jane ;
Steere, Allen C. .
CLINICAL INFECTIOUS DISEASES, 2017, 64 (08) :1074-1080
[4]   Two-Tiered Antibody Testing for Lyme Disease With Use of 2 Enzyme Immunoassays, a Whole-Cell Sonicate Enzyme Immunoassay Followed by a VlsE C6 Peptide Enzyme Immunoassay [J].
Branda, John A. ;
Linskey, Katy ;
Kim, Yeowon A. ;
Steere, Allen C. ;
Ferraro, Mary Jane .
CLINICAL INFECTIOUS DISEASES, 2011, 53 (06) :541-547
[5]   Guidelines for the diagnosis of tick-borne bacterial diseases in Europe [J].
Brouqui, P ;
Bacellar, F ;
Baranton, G ;
Birtles, RJ ;
Bjoërsdorff, A ;
Blanco, JR ;
Caruso, G ;
Cinco, M ;
Fournier, PE ;
Francavilla, E ;
Jensenius, M ;
Kazar, J ;
Laferl, H ;
Lakos, A ;
Furlan, SL ;
Maurin, M ;
Oteo, JA ;
Parola, P ;
Perez-Eid, C ;
Peter, O ;
Postic, D ;
Raoult, D ;
Tellez, A ;
Tselentis, Y ;
Wilske, B .
CLINICAL MICROBIOLOGY AND INFECTION, 2004, 10 (12) :1108-1132
[6]   Evaluation of commercial screening tests and blot assays for the diagnosis of Lyme borreliosis [J].
Busson, Laurent ;
Reynders, Marijke ;
Van den Wijngaert, Sigi ;
Dahma, Hafid ;
Decolvenaer, Marc ;
Vasseur, Liesbet ;
Vandenberg, Olivier .
DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE, 2012, 73 (03) :246-251
[7]  
Centers for Disease Control and Prevention (CDC), 1995, MMWR Morb Mortal Wkly Rep, V44, P590
[8]   Is there a Lyme-like disease in Australia? Summary of the findings to date [J].
Chalada, Melissa Judith ;
Stenos, John ;
Bradbury, Richard Stewart .
ONE HEALTH, 2016, 2 :42-54
[9]   Concordance of four commercial enzyme immunoassay and three immunoblot formats for the detection of Lyme borreliosis antibodies in human serum: the two-tier approach remains [J].
Dickeson, David J. ;
Chen, Sharon C-A. ;
Sintchenko, Vitali G. .
PATHOLOGY, 2016, 48 (03) :251-256
[10]   ANTIBODY-RESPONSES TO THE 3 GENOMIC GROUPS OF BORRELIA-BURGDORFERI IN EUROPEAN LYME BORRELIOSIS [J].
DRESSLER, F ;
ACKERMANN, R ;
STEERE, AC .
JOURNAL OF INFECTIOUS DISEASES, 1994, 169 (02) :313-318