Abstract:
:The analytical performance of the AIX1000 system, a fully automated and recently FDA-cleared rapid plasma reagin (RPR) system, was evaluated by comparison to a manual RPR test in a traditional syphilis testing algorithm. A total of 1,028 consecutive serum samples submitted for syphilis testing to the University of North Carolina Hospitals Clinical Immunology Laboratory were tested per each manufacturer's instructions. Among those samples, 996 were nonreactive and 20 were reactive using both the ASI RPR card system and the AIX1000 system. Of the 12 discrepant specimens, 11 were AIX1000 reactive and ASI card nonreactive whereas 1 specimen was ASI card reactive and AIX1000 nonreactive. The sensitivity and specificity of the manual ASI card were 76.0% and 99.8%, respectively, while the sensitivity and specificity of the AIX100 were 100.0% and 99.4%, respectively (sensitivity P = 0.03). Among the 20 concordant reactive specimens, 68.4% of the titers agreed within ±1 dilution between methods. Reproducibility testing of the AIX1000 system demonstrated qualitative and semiquantitative (within ±1 dilution) agreement between specimens tested on different days of 96.0% and 76.0%, respectively, and 100.0% agreement between replicates within the same run. One of 24 samples analyzed under other disease conditions was reactive on both the AIX1000 system and the ASI card. Overall, the fully automated AIX1000 system demonstrated significantly enhanced sensitivity and specificity similar to that of the manual ASI RPR card test, making the AIX1000 system suitable for the laboratory diagnosis of syphilis in a clinical laboratory setting.
journal_name
J Clin Microbioljournal_title
Journal of clinical microbiologyauthors
Sanfilippo AM,Freeman K,Schmitz JLdoi
10.1128/JCM.00214-18subject
Has Abstractpub_date
2018-07-26 00:00:00issue
8eissn
0095-1137issn
1098-660Xpii
JCM.00214-18journal_volume
56pub_type
杂志文章abstract::The aim of this study was to determine if gastroenteric viruses were present on surfaces and equipment in a pediatric primary immunodeficiency unit (PPIU) by environmental sampling using swabs and subsequent nucleic acid extraction and reverse transcriptase PCR assays. A PPIU was chosen, and 11 swabs were taken at the...
journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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journal_title:Journal of clinical microbiology
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更新日期:2000-07-01 00:00:00
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journal_title:Journal of clinical microbiology
pub_type: 杂志文章
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journal_title:Journal of clinical microbiology
pub_type: 杂志文章
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更新日期:1996-12-01 00:00:00
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journal_title:Journal of clinical microbiology
pub_type: 杂志文章
doi:10.1128/JCM.11.6.720-723.1980
更新日期:1980-06-01 00:00:00