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01.12.2015 | Research article | Ausgabe 1/2015 Open Access

BMC Urology 1/2015

Evaluation of a rapid quantitative determination method of PSA concentration with gold immunochromatographic strips

Zeitschrift:
BMC Urology > Ausgabe 1/2015
Autoren:
Cheng-Ching Wu, Hung-Yu Lin, Chao-Ping Wang, Li-Fen Lu, Teng-Hung Yu, Wei-Chin Hung, Jer-Yiing Houng, Fu-Mei Chung, Yau-Jiunn Lee, Jin-Jia Hu
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

Conceived and designed the experiments: Wu CC, Wang CP, Lin HY, Lee YJ, and Hu JJ. Performed the experiments: Lu LF, Yu TH, Houng JY, and Hung WC. Analyzed the data: Chung FM and Houng JY. Contributed reagents/ materials/analysis tools: Wu CC, Lin HY, and Hu JJ. Wrote the paper: Wu CC, Chung FM, Lee YJ, and Hu JJ. All authors have read and approved the final version of the manuscript.

Abstract

Background

Prostate cancer remains the most common cancer in men. Qualitative or semi-quantitative immunochromatographic measurements of prostate specific antigen (PSA) have been shown to be simple, noninvasive and feasible. The aim of this study was to evaluate an optimized gold immunochromatographic strip device for the detection of PSA, in which the results can be analysed using a Chromogenic Rapid Test Reader to quantitatively assess the test results.

Methods

This reader measures the reflectance of the signal line via a charge-coupled device camera. For quantitative analysis, PSA concentration was computed via a calibration equation. Capillary blood samples from 305 men were evaluated, and two independent observers interpreted the test results after 12 min. Blood samples were also collected and tested with a conventional quantitative assay.

Results

Sensitivity, specificity, positive and negative predictive values, and accuracy of the PSA rapid quantitative test system were 100, 96.6, 89.5, 100, and 97.4 %, respectively. Reproducibility of the test was 99.2, and interobserver variation was 8 % with a false positive rate of 3.4 %. The correlation coefficient between the ordinary quantitative assay and the rapid quantitative test was 0.960.

Conclusions

The PSA rapid quantitative test system provided results quickly and was easy to use, so that tests using this system can be easily performed at outpatient clinics or elsewhere. This system may also be useful for initial cancer screening and for point-of-care testing, because results can be obtained within 12 min and at a cost lower than that of conventional quantitative assays.
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