title: Development of an ELISA for sPSP94 and utility of the sPSP94/sPSA ratio as a diagnostic indicator to differentiate between benign prostatic hyperplasia and prostate cancer.
abstract: BACKGROUND
  The serum PSA (sPSA) test has low specificity for prostate cancer (PCa), since sPSA also rises in benign prostatic hyperplasia (BPH). Serum PSP94 (sPSP94), a major secreted prostate protein, is indicated as a PCa marker. The potential of sPSP94 and sPSA in conjunction with each other to improve specificity of diagnostic test for PCa needs to be evaluated.
  
  
  METHODS
  PCa patients (n=33), BPH patients (n=44) and healthy controls (n=50) were recruited. A serum-based sandwich ELISA was developed to measure sPSP94 concentrations. Utility of sPSP94 in improving specificity of sPSA test was evaluated by studying sPSP94/sPSA ratios of study participants.
  
  
  RESULTS
  Considerable decrease in overlap among sPSP94/sPSA ratio values of BPH and PCa patients was observed, as compared to sPSP94 or sPSA alone. For differentiating between BPH and PCa patients, this ratio had a maximum area under the curve (AUC) of 0.859 (P=0.0132) and had a comparable sensitivity (90.91%) to sPSA with an increased specificity of 70.45%. Further, decision curve analysis (DCA) showed that sPSP94/sPSA ratio had a superior net benefit in identifying PCa, in patients opting for biopsy.
  
  
  CONCLUSIONS
  The sPSP94/sPSA ratio can be a better differentiating marker between BPH and PCa, than sPSP94 or sPSA alone.
authors: Department of Biochemistry & Clinical Nutrition, Seth G.S. Medical College & K.E.M Hospital, Parel, Mumbai, India. Electronic address: d_paralkar@hotmail.com.
authors: Deepa R
authors: DR
authors: Mhatre
authors: Division of Structural Biology, National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, India.
authors: Smita D
authors: SD
authors: Mahale
authors: Department of Molecular Immunodiagnostics, National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, India.
authors: Mohammed I
authors: MI
authors: Khatkhatay
authors: Division of Structural Biology, National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, India.
authors: Swapna S
authors: SS
authors: Desai
authors: Division of Structural Biology, National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, India.
authors: Dhanashree D
authors: DD
authors: Jagtap
authors: Department of Urology, Seth G.S. Medical College & K.E.M Hospital, Parel, Mumbai, India.
authors: Jayesh V
authors: JV
authors: Dhabalia
authors: Department of Genitourinary Oncology, Tata Memorial Hospital, Parel, Mumbai, India.
authors: Hemant B
authors: HB
authors: Tongaonkar
authors: Department of Molecular Immunodiagnostics, National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, India.
authors: Meena P
authors: MP
authors: Desai
authors: Department of Biochemistry & Clinical Nutrition, Seth G.S. Medical College & K.E.M Hospital, Parel, Mumbai, India.
authors: Sucheta P
authors: SP
authors: Dandekar
authors: Department of Biochemistry & Clinical Nutrition, Seth G.S. Medical College & K.E.M Hospital, Parel, Mumbai, India.
authors: Anand M
authors: AM
authors: Varadkar
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis; D016022:Case-Control Studies; D015331:Cohort Studies; D003937:Diagnosis, Differential; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D017430:Prostate-Specific Antigen / Q000097:blood*; D011470:Prostatic Hyperplasia / Q000097:blood* / Q000175:diagnosis*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis*; D029584:Prostatic Secretory Proteins / Q000097:blood*
chemical_list: D015415:Biomarkers; D029584:Prostatic Secretory Proteins; C043076:beta-microseminoprotein; D017430:Prostate-Specific Antigen
keywords: BPH; ELISA; PCa; sPSP94; sPSP94/sPSA