25.11.2013, 22:24
Med Microbiol Immunol. 2013 Nov 12. [Epub ahead of print]
Utility of serodiagnostics designed for use in the United States for detection of Lyme borreliosis acquired in Europe and vice versa.
Wormser GP, Tang AT, Schimmoeller NR, Bittker S, Cooper D, Visintainer P, Aguero-Rosenfeld ME, Ogrinc K, Strle F, Stanek G.
Source
Division of Infectious Diseases, New York Medical College, Valhalla, NY, 10595, USA, GARY_WORMSER@NYMC.EDU.
Abstract
Although two-tier testing is standard practice in both the United States and Europe for the serologic diagnosis of Lyme borreliosis (LB), the test kits generally differ. The purpose of this study was to determine if the testing used in the United States will detect LB acquired in Europe and vice versa. Testing was performed on a convenience sample of archived sera from 40 LB patients from Austria and 39 from the United States, using first- and second-tier test kits from both the United States and Europe. The sensitivity of four first-tier tests from Europe and two first-tier tests from the United States was similar. Thus, two-tier testing was compared to the C6 ELISA as the first-tier test, since it is licensed in both the United States and Europe. The sensitivity of C6 two-tier testing with US assays was 9/40 (22.5 % [95 % CI 10.8-38.5 %]) for detection of LB acquired in Europe, and just 20.0 % (95 % CI 2.5-55.6 %) in the ten European patients with neurologic involvement. These results differed significantly from the sensitivity of European C6 two-tier testing that was 70.0 % (95 % CI 53.5-83.4 %) overall (p < 0.001) and 90.0 % (95 % CI 55.5-99.7 %) for the European patients with neurologic manifestations specifically (p = 0.016). In contrast, the sensitivity of European and US C6 two-tier testing was similar for detection of LB acquired in the United States. Two-tier serologic testing with the US test kits may be unsatisfactory for detection of LB acquired in Europe. First-tier testing with an assay such as the C6 ELISA should be considered as a stand-alone diagnostic strategy in such cases.
PMID:
24218117
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24218117
Ziel dieser Studie war es, festzustellen, ob die in den Vereinigten Staaten verwendet Tests in Europa erworbe LB erkennen und umgekehrt.
Die Tests wurden Seren von 40 Patienten LB aus Österreich und 39 aus den Vereinigten Staaten durchgeführt.
Die Sensitivität der vier großen Tests aus Europa und zwei erstrangigen Tests aus den USA waren ähnlich.
Die Sensitivität der C6 Zwei-Stufen-Tests mit US -Assays betrug (9 /40 22,5% [95% KI 10,8-38,5 %] ) für die Erkennung von in Europa erworben LB, und nur 20,0% (95% CI 2,5-55,6 %) bei den zehn europäischen Patienten mit neurologischen Beteiligung. Diese Ergebnisse unterscheiden sich deutlich von der Sensitivität der Europäischen C6 Zwei-Stufen-Tests, die 70,0% betrug (95% CI 53,5-83,4 %), insgesamt (p <0,001) und 90,0% (95% CI 55,5-99,7 %).
(Eine Sensitivität von 20% bedeutet z.B., dass von 100 tatsächlich Erkrankten mit dem jeweiligen Testskit nur 20 erkannt werden, während bei 80% der tatsächlich Erkrankten durch das Raster fallen und die Infektion unerkannt bleibt!)
Utility of serodiagnostics designed for use in the United States for detection of Lyme borreliosis acquired in Europe and vice versa.
Wormser GP, Tang AT, Schimmoeller NR, Bittker S, Cooper D, Visintainer P, Aguero-Rosenfeld ME, Ogrinc K, Strle F, Stanek G.
Source
Division of Infectious Diseases, New York Medical College, Valhalla, NY, 10595, USA, GARY_WORMSER@NYMC.EDU.
Abstract
Although two-tier testing is standard practice in both the United States and Europe for the serologic diagnosis of Lyme borreliosis (LB), the test kits generally differ. The purpose of this study was to determine if the testing used in the United States will detect LB acquired in Europe and vice versa. Testing was performed on a convenience sample of archived sera from 40 LB patients from Austria and 39 from the United States, using first- and second-tier test kits from both the United States and Europe. The sensitivity of four first-tier tests from Europe and two first-tier tests from the United States was similar. Thus, two-tier testing was compared to the C6 ELISA as the first-tier test, since it is licensed in both the United States and Europe. The sensitivity of C6 two-tier testing with US assays was 9/40 (22.5 % [95 % CI 10.8-38.5 %]) for detection of LB acquired in Europe, and just 20.0 % (95 % CI 2.5-55.6 %) in the ten European patients with neurologic involvement. These results differed significantly from the sensitivity of European C6 two-tier testing that was 70.0 % (95 % CI 53.5-83.4 %) overall (p < 0.001) and 90.0 % (95 % CI 55.5-99.7 %) for the European patients with neurologic manifestations specifically (p = 0.016). In contrast, the sensitivity of European and US C6 two-tier testing was similar for detection of LB acquired in the United States. Two-tier serologic testing with the US test kits may be unsatisfactory for detection of LB acquired in Europe. First-tier testing with an assay such as the C6 ELISA should be considered as a stand-alone diagnostic strategy in such cases.
PMID:
24218117
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24218117
Ziel dieser Studie war es, festzustellen, ob die in den Vereinigten Staaten verwendet Tests in Europa erworbe LB erkennen und umgekehrt.
Die Tests wurden Seren von 40 Patienten LB aus Österreich und 39 aus den Vereinigten Staaten durchgeführt.
Die Sensitivität der vier großen Tests aus Europa und zwei erstrangigen Tests aus den USA waren ähnlich.
Die Sensitivität der C6 Zwei-Stufen-Tests mit US -Assays betrug (9 /40 22,5% [95% KI 10,8-38,5 %] ) für die Erkennung von in Europa erworben LB, und nur 20,0% (95% CI 2,5-55,6 %) bei den zehn europäischen Patienten mit neurologischen Beteiligung. Diese Ergebnisse unterscheiden sich deutlich von der Sensitivität der Europäischen C6 Zwei-Stufen-Tests, die 70,0% betrug (95% CI 53,5-83,4 %), insgesamt (p <0,001) und 90,0% (95% CI 55,5-99,7 %).
(Eine Sensitivität von 20% bedeutet z.B., dass von 100 tatsächlich Erkrankten mit dem jeweiligen Testskit nur 20 erkannt werden, während bei 80% der tatsächlich Erkrankten durch das Raster fallen und die Infektion unerkannt bleibt!)