immunoassay HIV 1+2 test

This EIA kit is for the detection of circulating antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and/or Human Immunodeficiency Virus Type 2 (HIV-2) in Human serum or plasma and is indicated as a screening test for serum or plasma and as an aid in the diagnosis of potential infection with HIV-1 and/or HIV-2.Human Immunodeficiency Virus Type (HIV-1) has been isolated from patients with AIDS and AIDS-related complex (ARC). HIV-1 was thought to be the sole causive agent of these syndromes until 1986, when a second type of Human Immunodeficiency Virus (HIV-2) was isolated and also reported to cause AIDS. Since the initial discovery, more than 600 cases of HIV-2 infection have been documented worldwide, with over 40 cases of AIDS related to HIV-2.
Both viruses have the same morphology and lymphotropism, and the modes of transmission appear to be identical. In addition, HIV-1 and HIV-2 genomes exhibit about 60% homology in conserved genes such as and. Serologic studies have also shown that the core proteins of HIV-1 and HIV-2 display frequent cross-reactivity whereas the envelope proteins are more type-specific.
Despite this immunologic cross-reactivity, detection of antibodies to HIV-2 with any of the licensed HIV-1 enzyme immunoassays is highly variable. This HIV-1/HIV-2 EIA was developed to detect antibodies to HIV-1 and /or HIV-2, for blood screening and diagnostic purposes.
Any specimen that reacts in an initial test with the HIV-1/HIV-2 EIA must be retested in duplicate with the other company’s HIV-1/HIV-2 EIA. Repeatably reactive specimens may contain antibodies to either HIV-1 or HIV-2. Therefore, additional, more specific or supplemental tests for antibodies to both HIV-1 and HIV-2 such as immunoblot, immunofluorescence, radioimmuno-precipitation must be performed to verify presence of antibodies to HIV.The HIV-1/HIV-2 EIA utilizes a detection system where microplate wells are coated with synthetic peptides and recombinant antigen corresponding to a highly antigenic segment of HIV-1/HIV-2 envelope and core proteins. Serum or plasma specimens, controls are added to the wells. During incubation, antibodies specific for HIV-1 and HIV-2 present in the specimen will bind to the peptides and recombinant antigen fixed onto the micro plate wells. The wells are washed to remove unbound materials, and recombinant antigen conjugate will bind to the antigen-antibody complex and excess unbound enzyme conjugates are again removed by washing. The enzyme substrate, tetramethylbenzidine (TMB), is added upon incubation the substrate will be hydrolyzed by the bound enzyme and a blue or blue-green color develops in wells containing HIV-1 and/or HIV-2 specific antibodies. The enzyme reaction is stopped by the addition of sulphuric acid. The intensity of color developed is read spectrophotometrically at 450nm(450 nm/630 nm) and is proportional to the amount of antibodies present in the specimen.Description
96T
1
Micro titer Well
1
2
Sample Diluents
6ml
3
Enzyme Conjugate
12ml
4
Negative Control
1ml
5
Positive Control(HIV-1)
1ml
6
Positive Control(HIV-2)
1ml
7
Wash Buffer Concentrate (20x)
30ml
8
Substrate Solution A
6ml
9
Substrate Solution B
6ml
10
Stop Solution
6ml
11
User manual
1 copyMicropipettes: 0.02, 0.05, 0.10, 0.15, 0.20, and 1.0 ml.Disposable pipette tips.Distilled or deionized water.HumidifiedBox capable of maintaining 37°CAbsorbent paper or paper towel.Micro titer plate or strip-well washerMicro titer plate reader with 450nm (or 450 nm/630 nm)wavelengthTimer PRECAUTION FOR USERSFor in-vitro diagnostic use only.Do not use kit beyond expiration date.Do not mix components from kits with different lot number.Avoid microbial contamination of reagents.Do not pipet reagent by mouth and no smoking or eating while performing assays.Wear gloves during the whole process and avoid reagents or specimen spilling-out.Wipe up the spills using 5% hypochlorite solution.Decontaminate all liquids or solid wastes before deposing. SPECIMEN COLLECTION AND PREPARATION
Serum should be prepared from a whole blood specimen obtained by acceptable medical techniques. Either serum or plasma can be used in this test. Remove serum or plasma from the clot or blood cells as soon as possible to avoid hemolysis. Specimen with extensive particulate should be clarified by centrifugation prior to use. Specimen frozen at -20°C or colder may be used. Avoid repeated freeze thaw. The clinical performances of BIONEOVAN.CO.LTD SCREENING HIV 1+2 ELISA have been evaluated by a panel of samples obtained from 11045 healthy blood donators in 10 testing centers and by a panel of samples from 783 HIV 1/2 positive patients -757 HIV-1,7 HIV-2 and 17HIV -1(M). The positive samples have been characterized based upon the individual patient CD4+count and /or Western Blot (WB) or NAT. Results obtained in individual laboratories my differ.
Analytical specificity:
No cross reactivity was observed with specimens from patients infected with HAV, HCV, HBV, HTLV, CMV, and TP. No high dose hook effect and rheumatoid factor interference observed during clinical testing. The assay performance characteristics are unaffected from elevated concentrations of bilirubin, hemoglobin, and triolein. Frozen specimens have been tested to check for interferences due to collection and storage.
Specimen
No
-
+
-(WB)
Specificity
Donors
11045
11033
12
12
99.89%
Specimen
No
+
-
+(WB)
Sensitivity
HIV-1
757
756
1
757
99.86%
HIV-2
7
7
1
7
100.00%
HIV - 1 Subtypes
No. samples
Result
WB
A
1
+
+
B
1
+
+
C
9
+(9/9)
+
B'+C
4
+(4/4)
+
E
1
+
+
G
1
+
+

Sales department
Aileen
Bioneovan Co.,Ltd
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