title: Development of an integrase-based ELISA for specific diagnosis of individuals infected with HIV.
abstract: Currently, enzyme immunoassays (EIAs) are the most common immunological diagnostic methods that are used as the screening tool in HIV detection. Among all three major genes of HIV, the products of gag and env are usually used in EIAs (ELISAs and rapid tests). Hence, the presence of cross reacting antibodies against these antigens leads to the appearance of repetitive false positive results in screening tests. Re-testing the primary reactive samples with EIAs using other HIV antigens can considerably reduce the rate of false positive results. The products of pol gene may act as an appropriate candidate in this context. Integrase is a conserved and immunogenic product of HIV, encoded by the pol gene. The aim of this research was to determine the sensitivity and specificity of an ELISA detecting integrase antibodies. Recombinant integrase was produced in Escherichia coli to develop the integrase-based ELISA. Assay performance was evaluated by HIV positive and negative sera and an HIV panel of BBI (PRB-601). The sensitivity and specificity of assay was determined as 96.7 [95% confidence interval: 91.3-98.9%] and 100% [95% CI: 96.1-100%], respectively. High specificity of this assay may suggest its possible use in the detection of HIV.
authors.affiliation: Diagnostic Biotechnology Unit, Pasteur institute of Iran, Research and Production complex, Postal Code: 3159915111, 25th kilometer of Tehran-Karaj highway, Iran. Electronic address: z_rikhtegaran@pasteur.ac.ir.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Rikhtegaran Tehrani
authors.affiliation: Virology Department, Pasteur institute of Iran, No. 69, Pasteur ave, Postal Code: 1316943551, Tehran, Iran. Electronic address: azadmanesh@pasteur.ac.ir.
authors.forename: Kayhan
authors.initials: K
authors.lastname: Azadmanesh
authors.affiliation: Epidemiology Department, Pasteur institute of Iran, No. 69, Pasteur ave, Postal Code: 1316943551, Tehran, Iran. Electronic address: mostafavi@pasteur.ac.ir.
authors.forename: Ehsan
authors.initials: E
authors.lastname: Mostafavi
authors.affiliation: Hematology Department, Iran University of Medical Sciences, Hemmat highway, Postal Code: 1449614535, Tehran, Iran. Electronic address: shahrzadsori@yahoo.com.
authors.forename: Shahrzad
authors.initials: S
authors.lastname: Soori
authors.affiliation: Biotechnology Department, Pasteur institute of Iran, No. 69, Pasteur ave, Postal Code: 1316943551, Tehran, Iran. Electronic address: m.azizi@pasteur.ac.ir.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Azizi
authors.affiliation: Diagnostic Biotechnology Unit, Pasteur Institute of Iran, Research and Production Complex, Postal Code: 3159915111, 25th kilometer of Tehran -Karaj highway, Tehran, Iran. Electronic address: khabiri@pasteur.ac.ir.
authors.forename: Alireza
authors.initials: A
authors.lastname: Khabiri
mesh_terms: D000956:Antigens, Viral / Q000235:genetics / Q000276:immunology; D003955:Diagnostic Tests, Routine / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D004926:Escherichia coli / Q000235:genetics; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D019427:HIV Integrase / Q000235:genetics / Q000276:immunology*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D011994:Recombinant Proteins / Q000235:genetics / Q000276:immunology; D012680:Sensitivity and Specificity
chemical_list: D000956:Antigens, Viral; D015483:HIV Antibodies; D011994:Recombinant Proteins; D019427:HIV Integrase
keywords: ELISA; False positive; HIV detection; Integrase; p31