Evaluation of the fully automated AIX1000 rapid plasma reagin system compared to a manual plasma reagin testing method for the diagnosis of syphilis.

Abstract:

:The analytical performance of the FDA-cleared AIX1000 automated RPR testing platform was evaluated in comparison to manual RPR card testing. Eight hundred thirty-three patient serum samples were analyzed, 87 samples were positive by the AIX1000, 108 were positive by the manual test method; overall agreement between methods was 96.5% (κ = 0.83). Cases were further classified by clinical and laboratory-based confirmation of disease, to which reactivity rates were compared, yielding sensitivities of 96.4% and 100%, and specificities of 99.2% and 96.8% for the automated and manual RPR methods, respectively. The difference in specificity between methods was statistically significant (P < 0.001). Twenty-five of 29 samples with discordant results were reactive by manual testing (titers of 1:1 or 1:2); 21 of 25 patients with negative AIX100 results were identified to have histories of remote, treated syphilis. Overall, the AIX1000 platform demonstrated excellent agreement with the manual RPR method; discrepancies occurred with specimens at the threshold of reactivity.

authors

Pyden A,Kang AD,Amato S,Dutta S,Berg G,Riedel S

doi

10.1016/j.diagmicrobio.2020.115081

subject

Has Abstract

pub_date

2020-08-01 00:00:00

pages

115081

issue

4

eissn

0732-8893

issn

1879-0070

pii

S0732-8893(20)30458-2

journal_volume

97

pub_type

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