The authors declare that they have no competing interests.
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.
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.
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.
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.
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.
Lein M, Jung K, Schnorr D, Henke W, Brux B, Loening SA. Rapid screening of PSA: evaluation of an immunochemical membrane strip test. Clin Chem. 1995;41(10):1545–7. PubMed
Lein M, Jung K, Schnorr D, Henke W, Loening SA. Strip test for the quick detection of increased concentrations of prostate-specific antigen in blood. Eur J Clin Chem Clin Biochem. 1996;34(6):511–4. PubMed
Madersbacher S, Mian C, Maier U, Simak R. Validation of a 10-min dipstick test for serum prostate-specific antigen. Eur Urol. 1996;30(4):446–50. PubMed
Graves HC. Issues on standardization of immunoassays for prostate- specific antigen: a review. Clin Invest Med. 1993;16(6):415–24. PubMed
Jiang H, Min D, Ke D. A Rapid Quantitative Determination Method of AFP Concentration with Gold Immunochromatographic Strip. Journal of Computers. 2012;7(12):2868–75. CrossRef
Li Y, Zeng N, Min D. A novel image methodology for interpretation of gold immunochromatographic strip. Journal of Computers. 2011;6(3):540–7.
Catalona WJ, Richie JP, Ahmann FR, Hudson MA, Scardino PT, Flanigan RC, et al. Comparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men. J Urol. 1994;151(5):1283–90. PubMed
Vessella RL, Lange PH. Issues in the assessment of PSA immunoassays. Urol Clin North Am. 1993;20(4):607–19. PubMed
Zhou AM, Tewari PC, Bluestein BI, Caldwell GW, Larsen FL. Multiple forms of prostate-specific antigen in serum: differences in immunorecognition by monoclonal and polyclonal assays. Clin Chem. 1993;39(12):2483–91. PubMed
Wener MH, Daum PR, Close B, Brawer MK. Method-tomethod and lot-to-lot variation in assays for prostate-specific antigen. Am J Clin Pathol. 1994;101:387–8.
Erol B, Gulpinar MT, Bozdogan G, Ozkanli S, Onem K, Mungan G, et al. The cutoff level of free/total prostate specific antigen (f/t PSA) ratios in the diagnosis of prostate cancer: a validation study on a Turkish patient population in different age categories. Kaohsiung J Med Sci. 2014;30(11):545–50. CrossRefPubMed
- Evaluation of a rapid quantitative determination method of PSA concentration with gold immunochromatographic strips
- BioMed Central
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