Human anti-HIV 1+2 ELISA Kit (IVDEIA002)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Size
96T
Sample
serum, plasma
Species Reactivity
Human
Intended Use
This anti-HIV 1+2 ELISA is an enzyme-linked immunosorbent assay (ELISA) intended for qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) type 1 (group M - O) or type 2 in human serum or plasma samples. The assay can be utilized for screening of blood donors and/or as an aid in the diagnosis of clinical conditions related to infection with HIV-1 and /or HIV-2 - the etiological agents of the acquired immunodeficiency syndrome (AIDS).
Storage
The components of the kit will remain stable through the expiration date indicated on the label and package when stored between 2-8°C, do not freeze. To assure maximum performance of this anti-HIV 1+2 ELISA, during storage, protect the reagents from contamination with microorganism or chemicals.
Performance Characteristics
Evaluation study carried in Alkmaar, the Netherlands, between April and November 2005, demonstrated the following performance characteristics of this anti-HIV 1+2 ELISA: The diagnostic specificity of the kit was 99.85% as determined on all negative samples (5471) that were investigated. When examined on the unselected donors only (random and first time donors), the specificity was 99.92% (95% CI 99.84-100%).

This anti-HIV 1+2 ELISA test results on unselected donors:

All panels of HIV-1, HIV-1 subtype O and HIV-2 confirmed antibody positive samples that were used in this study were also tested reactive with this anti-HIV 1+2 ELISA which resulted in diagnostic sensitivity of 100%.
A total of 32 seroconversion panels, which represent 210 samples tested. 13 samples not classified from PRB918 and PRB917 because there are not data of Antigen or RNA determination required for the classification. 41 samples classified as negative. RNA and or Antigen negative. 61 samples classified as early-seroconversion. 95 samples classified as seroconversion.
The testing results also show that this anti-HIV 1+2 ELISA is a state-of-the-art compare to most of the currently available on the market CE-marked tests.
The analytical sensitivity was evaluated on PeliCheck anti-HIV panels. The analytical sensitivity of this anti-HIV 1+2 ELISA on the PeliCheck anti-HIV standard dilutions was comparable to other anti-HIV assays.
Analytical specificity: this anti-HIV 1+2 ELISA test results on samples from hospitalized patients and samples containing potentially cross-reacting blood-specimens.

In a separate study, the following specificity results were obtained:
- Possible high dose hook effect is eliminated due to the implementation of two-step procedure.
- Frozen positive/negative specimens have been tested to check for interferences due to collection and storage. The performance characteristics of this anti-HIV 1+2 ELISA were not affected for at least 3 freeze/thaw cycles.
- Samples from patents infected with hepatitis A, B, C as well as samples from patients infected with Treponema pallidum were tested with no cross-reactive reactions observed.
- 25 positive fresh serum samples tested in INSTITUTE FOR TROPICAL MEDICINE, BELGIUM have been tested with this anti-HIV 1+2 ELISA. All 25 positive fresh serum samples have been positive with this anti-HIV 1+2 ELISA.

Accuracy: The below tables represent the results of analytical sensitivity and reproducibility of this anti-HIV 1+2 ELISA as controlled with PeliSpyMulti-Marker run control and with QC sample tested in every plate - the 1:2048 dilution of the anti-HIV standard in this PeliSpy sample was consistently detected in all plates. QC sample was always detected in all plates.
General Description
Serological evidence of infection with HIV may be obtained by testing for presence of HIV antigens or antibodies in serum of individuals suspected for HIV infection. Antigen can generally be detected during both acute phase and the symptomatic phase of AIDS only. The antibodies to HIV-1 and/or HIV-2 can be detected throughout virtually the whole infection period, starting at or shortly after the acute phase and lasting till the end stage of AIDS. Therefore, the use of highly sensitive antibody assays is the primary approach in serodiagnosis of HIV infection. Apart from sexual transmission, the principal route of infection with HIV is blood transfusion. HIV can present both in cellular and cell-free fractions of human blood. Therefore, all donations of blood or plasma should be tested due to the risk of HIV transmission through contaminated blood. This can be effectively achieved by testing for the antibodies to HIV-1 and HIV-2 by using a highly sensitive ELISA tests.

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References


Investigation of binding characteristics of ritonavir with calf thymus DNA with the help of spectroscopic techniques and molecular simulation

JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS

Authors: Kou, Song-Bo; Zhou, Kai-Li; Lin, Zhen-Yi; Lou, Yan-Yue; Wang, Bao-Li; Shi, Jie-Hua; Liu, Ying-Xin

The binding behavior of ritonavir (RTV), a HIV/AIDS protease inhibitor, with ct-DNA was characterized through multiple testing technologies and theoretical calculation. The findings revealed that the RTV-DNA complex was formed through the noncovalent interaction mainly including conventional hydrogen bonds and carbon hydrogen bonds as well as hydrophobic interactions (pi-alkyl interactions). The stoichiometry and binding constant of the RTV-DNA complex were 1:1 and 1.87 x 10(3) M-1 at 298 K, respectively, indicating that RTV has moderate affinity with ct-DNA. The findings confirmed that RTV binds to the minor groove of DNA. The outcomes of CD experiments showed that the binding with RTV changed the conformation of DNA slightly. However, the conformation of RTV had obvious changes after binding to DNA, meaning that the flexibility of RTV molecule played an important role in stabilizing the RTV-DNA complex. Meanwhile, the results of DFT calculation revealed that the RTV and DNA interaction caused the changes in the frontier molecular orbitals, dipole moment and atomic charge distribution of RTV, altering the chemical properties of RTV when it bound to DNA. Communicated by Ramaswamy H. Sarma

Synthesis of Fused Oxepane HIV Integrase Inhibitor MK-1376

SYNTHESIS-STUTTGART

Authors: Maligres, Peter E.; Song, Zhiguo Jake; Strotman, Neil A.; Yin, Jinquin; Pei, Tao; Strotman, Hallena R.; Itoh, Tetsuji; Sherer, Edward C.; Humphrey, Guy R.

Controlling the absolute and relative stereochemistry of a seven-membered oxepane in the formation of HIV integrase inhibitor MK-1376 was accomplished through a strategy involving the use of asymmetric allylation and stereoconvergent, substrate-directed installation of an amine fragment. Surprising reactivity was demonstrated during the asymmetric allylation in which the allyl-pyrimidone product was formed reversibly. The stereoconvergent amine addition was accomplished through an elimination/addition sequence involving a quinone methide reactive intermediate, and nucleophilic trapping of the reactive quinone methide intermediate with methylamine. This novel approach delivered MK-1376, offering 100-fold greater productivity and 50-fold less waste than the initial synthetic chemistry route.

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