title: Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities.
abstract: OBJECTIVE
  To assess technical and operational performance of a dried blood spot (DBS)-based HIV-1 RNA service for remote healthcare facilities in a low-income country.
  
  
  METHODS
  A method comparison and operational evaluation of DBS RNA against conventional tests for early infant diagnosis of HIV and HIV RNA quantitation under field conditions in Tanzania.
  
  
  METHODS
  DBSs were prepared and plasma was frozen at -80 degrees C. DBSs were mailed and plasma couriered to a central laboratory for testing using the Abbott m2000 system. Infant diagnosis DBSs were also tested for HIV-1 DNA by ROCHE COBAS AmpliPrep/COBAS TaqMan System. Results of DBS RNA were compared with conventional tests; program performance was described.
  
  
  RESULTS
  Among 176 infant diagnosis participants, using a threshold of at least 1000 copies/ml, sensitivity and specificity of DBS versus plasma RNA were 1.00 and 0.99, and of DBS RNA versus DBS DNA were 0.97 and 1.00. Among 137 viral load monitoring participants, when plasma and DBS RNA were compared, r value was 0.9709; r value was 0.9675 for at least 5000 copies/ml but was 0.7301 for less than 5000 copies/ml. The highest plasma RNA value at which DBS RNA was not detected was 2084 copies/ml. Median (range) turnaround time from sample collection to result receipt at sites was 23 (4-69) days. The Tanzania mail service successfully transmitted all DBS and results between sites and the central laboratory.
  
  
  CONCLUSIONS
  Under program conditions in Tanzania, DBS provided HIV-1 RNA results comparable to conventional methods to remote healthcare facilities. DBS RNA testing is an alternative to liquid plasma for HIV-1 RNA services in remote areas.
authors.affiliation: Department of Medicine, Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Lofgren
authors.forename: Anne B
authors.initials: AB
authors.lastname: Morrissey
authors.forename: Caroline C
authors.initials: CC
authors.lastname: Chevallier
authors.forename: Anangisye I
authors.initials: AI
authors.lastname: Malabeja
authors.forename: Sally
authors.initials: S
authors.lastname: Edmonds
authors.forename: Ben
authors.initials: B
authors.lastname: Amos
authors.forename: David J
authors.initials: DJ
authors.lastname: Sifuna
authors.forename: Lorenz
authors.initials: L
authors.lastname: von Seidlein
authors.forename: Werner
authors.initials: W
authors.lastname: Schimana
authors.forename: Wendy S
authors.initials: WS
authors.lastname: Stevens
authors.forename: John A
authors.initials: JA
authors.lastname: Bartlett
authors.forename: John A
authors.initials: JA
authors.lastname: Crump
mesh_terms: D005260:Female; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000097:blood* / Q000175:diagnosis / Q000821:virology; D015497:HIV-1 / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D012367:RNA, Viral / Q000302:isolation & purification*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012423:Rural Health; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D013636:Tanzania / Q000453:epidemiology
chemical_list: D015483:HIV Antibodies; D012367:RNA, Viral