title: Evaluation of a rapid quantitative determination method of PSA concentration with gold immunochromatographic strips.
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.
authors.affiliation: Institute of Biomedical Engineering, National Cheng Kung University, Tainan, 70101, Taiwan. maxvic24@yahoo.com.tw.|Division of Cardiology, Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan. maxvic24@yahoo.com.tw.
authors.forename: Cheng-Ching
authors.initials: CC
authors.lastname: Wu
authors.affiliation: Department of Urology, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan. ed100464@yahoo.com.tw.
authors.forename: Hung-Yu
authors.initials: HY
authors.lastname: Lin
authors.affiliation: Division of Cardiology, Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan. ed100232@livemail.tw.|School of Medicine for International Students, I-Shou University, Kaohsiung, 82445, Taiwan. ed100232@livemail.tw.
authors.forename: Chao-Ping
authors.initials: CP
authors.lastname: Wang
authors.affiliation: Division of Cardiac Surgery, Department of Surgery, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan. laifan@seed.net.tw.
authors.forename: Li-Fen
authors.initials: LF
authors.lastname: Lu
authors.affiliation: Division of Cardiology, Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan. tenghungy@yahoo.com.tw.
authors.forename: Teng-Hung
authors.initials: TH
authors.lastname: Yu
authors.affiliation: Division of Cardiology, Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan. hwc.cct@msa.hinet.net.
authors.forename: Wei-Chin
authors.initials: WC
authors.lastname: Hung
authors.affiliation: Department of Medical Nutrition, Institute of Biotechnology and Chemical Engineering and I-Shou University, Kaohsiung, 82445, Taiwan. jyhoung@isu.edu.tw.
authors.forename: Jer-Yiing
authors.initials: JY
authors.lastname: Houng
authors.affiliation: Division of Cardiology, Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, 82445, Taiwan. chungfumei@gmail.com.
authors.forename: Fu-Mei
authors.initials: FM
authors.lastname: Chung
authors.affiliation: Lee's Endocrinology Clinic, Pingtung, 90000, Taiwan. lee@leesclinic.org.
authors.forename: Yau-Jiunn
authors.initials: YJ
authors.lastname: Lee
authors.affiliation: Institute of Biomedical Engineering, National Cheng Kung University, Tainan, 70101, Taiwan. maxvic24@gmail.com.
authors.forename: Jin-Jia
authors.initials: JJ
authors.lastname: Hu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood*; D002846:Chromatography, Affinity / Q000295:instrumentation*; D003199:Computer Systems; D004867:Equipment Design; D019544:Equipment Failure Analysis; D006046:Gold / Q000737:chemistry*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis; D011934:Reagent Strips; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D011934:Reagent Strips; D006046:Gold; D017430:Prostate-Specific Antigen