title: HIV-1 western blot assay: What determines an indeterminate status?
abstract: BACKGROUND
  The Western blot assay is the gold standard for the detection of antibodies to human immunodeficiency virus type 1 (HIV-1). However, indeterminate Western blot reactivity to HIV-1 proteins may occur in individuals, who may not be infected with HIV.
  
  
  OBJECTIVE
  This retrospective study was aimed to determine the diagnostic value of the interpretation criteria in relation to commercial kits for HIV-1 diagnosis.
  
  
  METHODS
  A total of 556 serum/plasma specimens collected from high-risk population attending our HIV clinic from 2000-2004 were tested by three different western blot kits: NEW LAV BLOT I (n=244), HIV BLOT 2.2; (n=112), Genetic Systems HIV-1 (n=237). And the results of western blot strips were analyzed using the various interpretation criteria: WHO/NACO, CDC/ ASTPHLD, ARC, FDA, CRSS and JHU. Some specimens were run on more than one kit. RT-PCR assay was performed on 5 specimens, which were indeterminate with LAV BLOT I.
  
  
  RESULTS
  The discrepancy in LAV BLOT I positive results were between 157(64)-176(72), and indeterminate results were between 44(18) to 63(25). No such variations were observed in genetic systems. There are some HIV negative (by PCR) specimens were indeterminate in LAV BLOT I revealing the kit more sensitive and less effective for diagnostic purpose.
  
  
  CONCLUSIONS
  The genetic systems kit is superior to other kits we analyzed and its results are concordant with HIV-1 PCR results. To report, the choice of western blot commercial kit is paramount important than the use of particular interpretation criteria for the diagnosis of HIV-1.
authors.affiliation: YRG Centre for AIDS Research and Education, VHS Campus, Taramani, Chennai, India.
authors.forename: Iqbal H
authors.initials: IH
authors.lastname: Syed
authors.forename: P
authors.initials: P
authors.lastname: Balakrishnan
authors.forename: Sunil S
authors.initials: SS
authors.lastname: Solomon
authors.forename: K G
authors.initials: KG
authors.lastname: Murugavel
authors.forename: N
authors.initials: N
authors.lastname: Kumarasamy
authors.forename: S
authors.initials: S
authors.lastname: Vidya
authors.forename: S P
authors.initials: SP
authors.lastname: Martin
authors.forename: S P
authors.initials: SP
authors.lastname: Thyagarajan
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
authors.forename: S
authors.initials: S
authors.lastname: Solomon
mesh_terms: D015153:Blotting, Western / Q000379:methods*; D015483:HIV Antibodies / Q000032:analysis*; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D066298:In Vitro Techniques; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies