Real-life evaluation of a human immunodeficiency virus screening algorithm using a single combined p24 antigen-antibody assay.
Eur J Clin Microbiol Infect Dis
; 32(3): 425-30, 2013 Mar.
Article
en En
| MEDLINE
| ID: mdl-23090728
ABSTRACT
Since May 2010, human immunodeficiency virus (HIV) screening in France has been performed using a single combined fourth-generation assay. One of our major concerns is to verify that this screening strategy is able to diagnose HIV primary infection as soon as possible. Thus, the sensitivity and specificity of this strategy were evaluated on 49,623 serum samples, including 29 primary infections, received for routine HIV testing between September 2010 and November 2011. Specimens were screened using the Enzygnost HIV Integral II enzyme-linked immunosorbent assay (ELISA) kit. All positive sera, according to the manufacturer's recommendations [signal-to-cutoff ratio (S/CO) ≥ 1] were retested using the Architect HIV Ag/Ab Combo. Moreover, we defined a grey zone (0.5 < S/CO < 1) and sera within this grey zone were retested using the VIDAS HIV DUO Ultra test and HIV-1 RNA was checked by the Abbott RealTime PCR kit. Screening tests were positive for all primary infections. All samples within the grey zone proved VIDAS HIV DUO Ultra and HIV-1 RNA negative. Overall, the ELISA test sensitivity and specificity were 100 and 99.79 %, respectively. The false-positive rate was higher when S/CO was in the low range (1 to 5). Adding a second screening test for positive sera reduced the false-positive rate from 0.20 to 0.02 %. HIV screening with a single combined assay did not miss any documented primary infection during this evaluation period, even without extending the positivity zone.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Virología
/
Anticuerpos Anti-VIH
/
Infecciones por VIH
/
Tamizaje Masivo
/
Proteína p24 del Núcleo del VIH
/
Técnicas de Laboratorio Clínico
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Evaluation_studies
/
Guideline
/
Prognostic_studies
/
Screening_studies
Límite:
Humans
/
Male
País/Región como asunto:
Europa
Idioma:
En
Revista:
Eur J Clin Microbiol Infect Dis
Asunto de la revista:
DOENCAS TRANSMISSIVEIS
/
MICROBIOLOGIA
Año:
2013
Tipo del documento:
Article
País de afiliación:
Francia
Pais de publicación:
ALEMANHA
/
ALEMANIA
/
DE
/
DEUSTCHLAND
/
GERMANY