Performance of the new HIV-1/2 diagnostic algorithm in Florida's public health testing population: a review of the first five months of utilization.
J Clin Virol
; 58 Suppl 1: e29-33, 2013 Dec.
Article
em En
| MEDLINE
| ID: mdl-24342476
ABSTRACT
OBJECTIVE:
The Centers for Disease Control and Prevention and the Association of Public Health Laboratories have proposed a new HIV-1/2 Diagnostic Algorithm a fourth-generation HIV-1/2 Ag/Ab immunoassay (IA) followed, when repeatedly reactive, by an HIV-1/HIV-2 antibody differentiation test, and if that is non-reactive, HIV-1 nucleic acid amplification testing (NAT). The objective of the study was to evaluate performance of the new algorithm after five months of utilization in our high volume, high HIV-1 seroprevalence public health population.METHODS:
Algorithm sensitivity and specificity was evaluated on 51,953 prospective serum or plasma specimens from individuals self-referring for HIV serostatus determination. Specimens were tested on the day of receipt or maintained at 4°C until the next testing opportunity. If the initial HIV-1/2 Ag/Ab IA (Abbott Combo) was nonreactive, a negative lab interpretation report would follow. If the initial IA was reactive, repeat screening in duplicate was immediately performed. Repeatedly reactive specimens were tested with an HIV-1/HIV-2 differentiation assay (Multispot [MS] HIV-1/HIV-2 Rapid Test) on the same or next workday. If the Abbott Combo-MS assays were discordant, HIV-1 NAT (APTIMA(®) HIV-1 RNA) was performed. In addition to the algorithm performance, we also evaluated the laboratory "specimen receipt to reporting" turnaround time (TAT).RESULTS:
The sensitivity and specificity of the new HIV Diagnostic Algorithm with serum and plasma specimens over the initial 5 month period was 100% (922/922) and 99.99% (51,030/51,031), respectively. Two algorithm-defined acute HIV-1 infections (AHI) were detected. In addition only 3 of the 992 MS secondary tests performed were interpreted as HIV-1 Indeterminate (HIV-1 recombinant gp41 reactivity only). Of these, 2 were HIV-1 NAT reactive, defined in-house as an early HIV infection (EHI) and one was HIV-1 NAT nonreactive, indicating a false positive initial screening result. Laboratory TAT for reporting concordant reactive Abbott Combo-MS results in ≤ 2 workdays was 96%, compared to 22% for reporting concordant reactive 3rd generation IA-Western blot results.CONCLUSIONS:
In our public health testing population, results from the new HIV Diagnostic Algorithm exceeded those of the 3rd generation IA-WB algorithm with respect to HIV-1 sensitivity. The identification of two algorithm-defined AHIs provided the opportunity to inform these individuals of their HIV status and link them to medical care earlier than the scheduled posttest counseling appointment.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
RNA Viral
/
Anticorpos Anti-HIV
/
Antígenos HIV
/
Infecções por HIV
/
HIV-1
/
HIV-2
/
Testes Diagnósticos de Rotina
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
/
Prognostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
J Clin Virol
Assunto da revista:
VIROLOGIA
Ano de publicação:
2013
Tipo de documento:
Article