title: Importance of collection methods and stability of oral fluid samples for hepatitis B surface antigen detection.
abstract: BACKGROUND
  Oral fluid (OF) sample collection and stability for HBsAg detection are not fully established. This study aims to investigate the applicability of OF collectors and sample stability for Hepatitis B virus surface antigen detection.
  
  
  METHODS
  Paired serum and OF samples were obtained from 191 individuals, and Chembio (Chembio Diagnostic System, USA) and Salivette (Sarstedt, Germany) devices were used for OF collection. Two HBsAg enzyme immunoassays (EIAs) were used (HBsAg One kit, Radim, Rome, Italy and ETI-MAK-4, DiaSorin, Vercelli, Italy) to determine the most efficient method according OF collector. Sample volume, incubation time, and cutoff (CO) value were evaluated. The stability of OF samples was determined under different environmental conditions.
  
  
  RESULTS
  Chembio samples analyzed using DiaSorin EIA without modification of the manufacturer's instructions, demonstrated a sensitivity of 95.24% and a specificity of 100%. Salivette samples analyzed with Radim EIA with receiver operating characteristic (ROC) curve for calculating the CO showed a sensitivity of 78.26% and a specificity of 89.88%. HBsAg was detected in Chembio and Salivette samples under different environmental conditions, but the Chembio samples were the most stable.
  
  
  CONCLUSIONS
  Both collectors can be used for HBsAg detection in OF samples, but some modifications of commercial EIAs should be incorporated for Salivette device. OF samples were reliably stable and could be stored for up to 90 days at 2-8°C.
authors: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors: Letícia
authors: L
authors: de Paula Scalioni
authors: Helena Medina
authors: HM
authors: Cruz
authors: Vanessa Salete
authors: VS
authors: de Paula
authors: Jaqueline
authors: J
authors: Corrêia Oliveira
authors: Renata
authors: R
authors: Tourinho Dos Santos
authors: Ana Rita Coimbra
authors: AR
authors: Motta-Castro
authors: Paula Guerra
authors: PG
authors: Murat
authors: Cristiane Alves
authors: CA
authors: Villela-Nogueira
authors: Lia Laura
authors: LL
authors: Lewis-Ximenez
authors: Elisabeth
authors: E
authors: Lampe
authors: Livia Melo
authors: LM
authors: Villar
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001938:Brazil; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D005260:Female; D006509:Hepatitis B / Q000175:diagnosis / Q000453:epidemiology* / Q000821:virology; D006514:Hepatitis B Surface Antigens / Q000097:blood / Q000737:chemistry / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D012372:ROC Curve; D012463:Saliva / Q000737:chemistry / Q000821:virology; D016036:Seroepidemiologic Studies; D013048:Specimen Handling / Q000295:instrumentation / Q000379:methods*; D013696:Temperature; D013997:Time Factors
chemical_list: D006514:Hepatitis B Surface Antigens