title: Comparison of Hepatitis C Virus RNA and antibody detection in dried blood spots and plasma specimens.
abstract: BACKGROUND
  Current diagnostic tests for Hepatitis C Virus (HCV) involve phlebotomy and serologic testing for HCV antibodies (anti-HCV) and RNA, which are not always feasible. Dried blood spots (DBS) present a minimally invasive sampling method and are suitable for sample collection, storage and testing.
  
  
  OBJECTIVE
  To assess the utility of DBS in HCV detection, we evaluated the sensitivity and specificity of DBS for anti-HCV and HCV RNA detection compared to plasma specimens.
  
  
  METHODS
  This cross-sectional validation study was conducted in the context of an existing prospective study of HCV in young injection drug users. Blood samples were collected by venipuncture into serum separator tubes (SST) and via finger stick onto Whatman 903(®) protein-saver cards. Plasma samples and eluates from the DBS were tested for anti-HCV using either a third generation enzyme-linked or chemiluminescent immunoassay (IA), and HCV RNA using discriminatory HCV transcription-mediated amplification assay (dHCV TMA). DBS results were compared to their corresponding plasma sample results.
  
  
  RESULTS
  148 participants were tested for anti-HCV and 132 participants were tested for HCV RNA. For anti-HCV, the sensitivity of DBS was 70%, specificity was 100%, positive predictive value (PPV) was 100%, negative predictive value (NPV) was 76% and Kappa was 0.69. For HCV RNA, the sensitivity of DBS was 90%, specificity was 100%, PPV was 100%, NPV was 94% and Kappa was 0.92.
  
  
  CONCLUSIONS
  DBS are sensitive and very specific in detecting anti-HCV and HCV RNA, demonstrate good correlation with plasma results, and have potential to facilitate diagnosis of HCV infection.
authors: University of California San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA. Electronic address: vic8@cdc.gov.
authors: E Kainne
authors: EK
authors: Dokubo
authors: University of California San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA.
authors: Jennifer
authors: J
authors: Evans
authors: Creative Testing Solutions, 2424 West Erie Drive, Tempe, AZ 85282, USA.
authors: Valerie
authors: V
authors: Winkelman
authors: Creative Testing Solutions, 2424 West Erie Drive, Tempe, AZ 85282, USA.
authors: Sherri
authors: S
authors: Cyrus
authors: Blood Systems Research Institute, 270 Masonic Avenue, San Francisco, CA 94118, USA.
authors: Leslie H
authors: LH
authors: Tobler
authors: University of California San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA.
authors: Alice
authors: A
authors: Asher
authors: University of California San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA.
authors: Alya
authors: A
authors: Briceno
authors: University of California San Francisco, 50 Beale Street, Suite 1200, San Francisco, CA 94105, USA.
authors: Kimberly
authors: K
authors: Page
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D003890:Desiccation; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D008297:Male; D021141:Nucleic Acid Amplification Techniques; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood*; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D055815:Young Adult
chemical_list: D018937:Hepatitis C Antibodies; D012367:RNA, Viral
keywords: Dried blood spot; HCV RNA; HCV antibody; Hepatitis C Virus; Injection drug use