MICROLISA HIV

 

INTENDED USE

MICROLISA HIV is an in-vitro qualitative enzyme immunoassay for the detection of antibodies to HIV-1 and /or HIV-2 in human serum or plasma. It is intended for screening of blood donors or other individuals at risk for HIV-1 and HIV-2 infection and for clinical diagnostic testing.

SALIENT FEATURES

  • Use of Envelope Antigens gp41,C terminus of gp120 for HIV-1& gp36 for HIV-2.
  • Detection of Group O & subtype C for HIV-1 prevalent in India.
  • Color coded reagents to monitor procedural steps.
  • Assay procedure: 90mins.
  • Longer shelf life: 15 months at 2-8°C.
  • Sensitivity & Specificity of 100% by WHO.
MICROLISA HIV test is an enzyme immunoassay based on Indirect Elisa. HIV envelop proteins gp-41, C terminus of gp-120 for HIV-1 and gp-36 for HIV-2 representing Immunodominant epitopes are coated onto microtiter wells. Specimens and controls are added to the microtiter wells and incubated. Antibodies to HIV-1 and HIV-2 if present in the specimen, will bind to the specific antigens adsorbed onto the surface of the wells. The plate is then washed to remove unbound material. Horseradish peroxidase (HRPO) conjugated anti-human IgG is added to each well. This conjugate will bind to HIV antigen-antibody complex present. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated. A blue colour will develop in proportion to the amount of HIV-1 and / or HIV-2 antibodies present in the specimen. The colour reaction is stopped by stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm. If the sample does not contain HIV-1 or HIV-2 antibodies then enzyme conjugate will not bind and the solution in the wells will be either colorless or only a faint background colour develops.
ORDERING INFORMATION
PRODUCT NAME PACK SIZE CATALOG NO.
MICROLISA HIV 96 Tests IR132096

EVALUATIONS
  • WHO EVALUATION:As per evaluation report dated 20th February, 1998 of WHO Collaborating Centre, Institutvoor Tropische Geneeskunde Nationalestraat 155-B 2000 Antwerpen, Belgium. Seven HIV-O sera were used in the reference panel all of which were tested positive by Microlisa-HIV. Microlisa-HIV was also tested on low performance and mixed panel from Boston Biomedica Inc. and the obtained results were found identical with Western Blot provided by BBI for the above panel. The specificity and sensitivity in this evaluation was found to be 100% on world wide panel.
  • Evaluation Reports of National HIV Reference Laboratories of Government of India (CMC Vellore), Drug Controller General (India), Directorate General of Health Services, Government of India, New Delhi (Letter dated 08 May, 1997). The Sensitivity and Specificity were found to be 100 % and 99.5%.
  • Indian Journal of Medical Microbiology claims 100 % Sensitivity and 100% Specificity of MICROLISA HIV.
  • NICD-DELHI-As per evaluation at National Institute of Communicable Diseases (DGHS) with 265 known samples the overall Sensitivity & Specificity was 100 % & 99.23 %.
  • Department of Microbiology, Nizam's Institute of Medical Sciences claimed the Sensitivity, Specificity and Efficiency to be 100%.
  • Approved by Drug Controller General of India (DCGI) for the usage in Blood Banks.

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