Assessment of the rapid test based on an immunochromatography technique for detecting anti-Treponema pallidum antibodies

Abstract

SUMMARYA rapid test based on an immunochromatography assay -Determine Syphilis TP (Abbott Lab.) for detecting specific antibodies to Treponema pallidum was evaluated against serum samples from patients with clinical, epidemiological and serological diagnosis of syphilis, patients with sexually transmitted disease other than syphilis, and individuals with negative serology for syphilis. The Determine test presented the sensitivity of 93.6%, specificity of 92.5%, and positive predictive value and negative predictive value of 95.2% and 93.7%, respectively. One serum sample from patient with recent latent syphilis showed a prozone reaction. Determine TM is a rapid assay, highly specific and easy to perform. This technique obviates the need of equipment and its diagnostic features demonstrate that it may be applicable as an alternative assay for syphilis screening under some emergency conditions or for patients living in remote localities.

Rapid tests for diagnosing syphilis: validation in an STD clinic in the Amazon Region, Brazil

“…Another study of Determine Syphilis TP, carried out in São Paulo, Brazil (Instituto Adolfo Lutz/Adolfo Lutz Institute), found a sensitivity of 93.6%, a specificity of 92.5%, and a VPP of 95.2% when compared to FTA-Abs and the TPHA 18 .…”

Lateral flow test strip based on colloidal selenium immunoassay for rapid detection of melamine in milk, milk powder, and animal feed

“…[27][28][29] Colloidal gold particles are costly, 30,31 and the preparation process for colloidal gold is relatively complicated. Considering the drawbacks of current methods for MEL detection, the aims of this study were to employ colloidal selenium particles for binding to antibodies against MEL and prepare a lateral flow test strip based on colloidal selenium immunoassay.…”

Laboratorial Diagnosis of Syphilis

“…It was analyzed 137 serum samples from patients with a clinical and laboratory diagnosis of syphilis (61), from healthy blood donors (50), individuals with sexually transmitted disease other than syphilis (3), and from individuals with other spirochetal diseases such as Lyme disease (20) and leptospirosis (3). The sensitivity was 95.1% (58/61) and specificity was 94.7% (72/76) (Sato et al, 2004).…”

“…Overall, these native antigen based Tp-WB assay is a useful additional confirmatory test for syphilis. A blot assay using recombinant antigens instead of fractionates native proteins had been described (Sato et al, 2004) and some are also commercially available, including Treponema Virablot IgG (Viramed Biotech) (Binnicker et al, 2011;Welch & Litwin, 2010) and INNO-LIA (Immunogenetics, Belgium) (Ebel et al, 2000). The immune-slot-blot assay is an "in house" technique prepared with three recombinant antigen rTp47, rTp17 and rTp15 immobilized on nitrocellulose strip.…”

“…Determine Syphilis TP (Abbott) has recombinant antigen TpN47 immobilized on nitrocellulose strips and use 50uL of sample, either whole blood, serum or plasma and results can be read in 5 to 20 minutes. For serum or plasma specimens, sensitivity range were 93.7 to 99.2% and specificity 92.4 to 100% (Diaz et al, 2004;Herring et al, 2006;Mabey et al, 2006a;Mabey et al, 2006b;Oshiro et al, 1999;Sato et al, 2003). For whole blood sample, the sensitivity ranged from 85,9% to 95.0%, and specificity was higher than 97.7% (Gianino et al, 2007;Mabey et al, 2006a;Siedner et al, 2004;Tinajeros et al, 2006) when performed in the reference laboratory.…”