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Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital.

Tiwari AK, Pandey PK, Dara RC, Rawat GS, Raina V, Bhargava R - Asian J Transfus Sci (2015 Jan-Jun)

Bottom Line: STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency.There was no cross-reactivity with other viral and auto-immune antibodies.No interference was observed from endogenous interfering substances like free hemoglobin or fats.

View Article: PubMed Central - PubMed

Affiliation: Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.

ABSTRACT

Context: Syphilis is a transfusion transmissible infections and it is mandatory to do serological test for syphilis (STS) on all donor blood samples. STS is usually based on detection of antibodies against the cardiolipin-lecithin antigen or against the Treponema-specific antigen. STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency.

Aims: This study was designed to evaluate the performance of newly introduced VITROS(®) syphilis Treponema pallidum agglutination (TPA) assay based on enhanced chemiluminescence principle for its analytical performance for use as a STS on donor blood samples at a tertiary care health center in National Capital Region, India.

Materials and methods: A total of 108 random blood units collected from the donors (both voluntary and replacement donors) and 28 known syphilis sero-reactive samples stored at -20°C, were used to evaluate the performance of VITROS(®) syphilis TPA assay based on enhanced chemiluminescence assay on VITROS(®) ECiQ immunodiagnostics system along with its analytical performance in terms of its sensitivity, precision, cross-reactivity and interference studies.

Results: VITROS(®) syphilis TPA showed 100% sensitivity and specificity with precision (20 days study) of <10% co-efficient of variation. There was no cross-reactivity with other viral and auto-immune antibodies. No interference was observed from endogenous interfering substances like free hemoglobin or fats.

Conclusions: Performance of the VITROS(®) syphilis TPA assay meets the requirements for its use as STS in blood bank, thus allowing consolidation with other transfusion transmittable infections screening assay on chemiluminescence platform, which is highly valuable for optimizing workflow and efficiency.

No MeSH data available.


Related in: MedlinePlus

The sensitivity and specificity of VITROS® syphilis Treponema pallidum agglutination assay and syphilis immunochromatography assay based on sample comparison data
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Figure 1: The sensitivity and specificity of VITROS® syphilis Treponema pallidum agglutination assay and syphilis immunochromatography assay based on sample comparison data

Mentions: Diagnostic accuracy was evaluated using a protocol based on NCCLS (CLSI) document EP9-A2. syphilis sero-negative and sero-reactive serum samples were tested for syphilis antibody using VITROS syphilis TPA assay, which is based on double antigen sandwich assay and one step syphilis anti-TP assay based on solid phase immunochromatograpic assay (SD Bioline syphilis 3.0). Twenty-five samples showed “reactive” results and 108 samples showed “nonreactive” results in both VITROS syphilis TPA of all the three different lots and syphilis immunochromatographic assay. Three samples showed discordant results, which were “reactive” in syphilis immunochromatographic assay and “nonreactive” in all the three different lots of VITROS syphilis TPA assay. All the three discordant samples were retested in syphilis TPHA assay and all these three samples were found to be negative in syphilis TPHA assay [Table 1]. Based on the above data, after resolution of three discordant samples, the sensitivity and specificity of VITROS syphilis assay was found to be 100%, whereas syphilis immunochromatographic assay showed sensitivity of 100% and specificity of 97% [Figure 1]. There was no lot-to-lot variation observed in VITROS syphilis TPA.


Evaluation of a new serological test for syphilis based on chemiluminescence assay in a tertiary care hospital.

Tiwari AK, Pandey PK, Dara RC, Rawat GS, Raina V, Bhargava R - Asian J Transfus Sci (2015 Jan-Jun)

The sensitivity and specificity of VITROS® syphilis Treponema pallidum agglutination assay and syphilis immunochromatography assay based on sample comparison data
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4339936&req=5

Figure 1: The sensitivity and specificity of VITROS® syphilis Treponema pallidum agglutination assay and syphilis immunochromatography assay based on sample comparison data
Mentions: Diagnostic accuracy was evaluated using a protocol based on NCCLS (CLSI) document EP9-A2. syphilis sero-negative and sero-reactive serum samples were tested for syphilis antibody using VITROS syphilis TPA assay, which is based on double antigen sandwich assay and one step syphilis anti-TP assay based on solid phase immunochromatograpic assay (SD Bioline syphilis 3.0). Twenty-five samples showed “reactive” results and 108 samples showed “nonreactive” results in both VITROS syphilis TPA of all the three different lots and syphilis immunochromatographic assay. Three samples showed discordant results, which were “reactive” in syphilis immunochromatographic assay and “nonreactive” in all the three different lots of VITROS syphilis TPA assay. All the three discordant samples were retested in syphilis TPHA assay and all these three samples were found to be negative in syphilis TPHA assay [Table 1]. Based on the above data, after resolution of three discordant samples, the sensitivity and specificity of VITROS syphilis assay was found to be 100%, whereas syphilis immunochromatographic assay showed sensitivity of 100% and specificity of 97% [Figure 1]. There was no lot-to-lot variation observed in VITROS syphilis TPA.

Bottom Line: STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency.There was no cross-reactivity with other viral and auto-immune antibodies.No interference was observed from endogenous interfering substances like free hemoglobin or fats.

View Article: PubMed Central - PubMed

Affiliation: Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.

ABSTRACT

Context: Syphilis is a transfusion transmissible infections and it is mandatory to do serological test for syphilis (STS) on all donor blood samples. STS is usually based on detection of antibodies against the cardiolipin-lecithin antigen or against the Treponema-specific antigen. STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency.

Aims: This study was designed to evaluate the performance of newly introduced VITROS(®) syphilis Treponema pallidum agglutination (TPA) assay based on enhanced chemiluminescence principle for its analytical performance for use as a STS on donor blood samples at a tertiary care health center in National Capital Region, India.

Materials and methods: A total of 108 random blood units collected from the donors (both voluntary and replacement donors) and 28 known syphilis sero-reactive samples stored at -20°C, were used to evaluate the performance of VITROS(®) syphilis TPA assay based on enhanced chemiluminescence assay on VITROS(®) ECiQ immunodiagnostics system along with its analytical performance in terms of its sensitivity, precision, cross-reactivity and interference studies.

Results: VITROS(®) syphilis TPA showed 100% sensitivity and specificity with precision (20 days study) of <10% co-efficient of variation. There was no cross-reactivity with other viral and auto-immune antibodies. No interference was observed from endogenous interfering substances like free hemoglobin or fats.

Conclusions: Performance of the VITROS(®) syphilis TPA assay meets the requirements for its use as STS in blood bank, thus allowing consolidation with other transfusion transmittable infections screening assay on chemiluminescence platform, which is highly valuable for optimizing workflow and efficiency.

No MeSH data available.


Related in: MedlinePlus