HIV-1 p24 ELISA Kit

Sample

Cell Culture Supernatants, Plasma, Serum.

Detection Method

sELISA

Intended Use

The HIV-1 p24 ELISA Kit (Residue Testing) is developed for quantitative detection of Human Immunodeficiency Virus-1 p24 (HIV-1 p24) in samples from CAR-T product preparation processing where it is used as a lentivirus vector. It is intended for research use only (RUO).

Contents of Kit

1. Pre-coated Anti-HIV-1 p24 Antibody Microplate, 1 plate Solid. Unopened: 2-8°C. Opened: 2-8°C
2. HIV-1 p24 Standard, 20 μg, Power. Unopened: 2-8°C. Opened: -70°C.
3. Biotin-Anti-HIV-1 p24 Antibody, 20 μg, Power. Unopened: 2-8°C. Opened: -70°C.
4. Streptavidin-HRP, 50 μL, Liquid. Unopened: 2-8°C, avoid light. Opened: 2-8°C, avoid light.
5. 10×Washing Buffer, 50 mL, Liquid. Unopened: 2-8°C. Opened: 2-8°C
6. 2×Dilution Buffer, 50 mL, Liquid. Unopened: 2-8°C. Opened: 2-8°C
7. Substrate Solution, 12 mL, Liquid. Unopened: 2-8°C, avoid light. Opened: 2-8°C, avoid light.
8. Stop Solution, 7 mL, Liquid. Unopened: 2-8°C. Opened: 2-8°C
9. 1×Lysis Buffer, 12 mL, Liquid. Unopened: 2-8°C. Opened: 2-8°C

Storage

Unopened kit should be stored at 2°C -8°C upon receiving.
Note:
a. Do not use reagents past their expiration date.
b. Find the expiration date on the outside packaging.

Precision

1. Intra-assay Precision
Three samples of known concentration were tested ten times on one plate to assess intra-assay precision.
2. Inter-assay Precision
Three samples of known concentration were tested in three separate assays to assess inter-assay precision.

Note: The example data is for reference only.

Sensitivity

The minimum detectable concentration of HIV-1 p24 is 1.556 pg/mL. The minimum detectable concentration was determined by adding twice standard deviations to the mean optical density value of twenty zero standard replicates and calculating the corresponding concentration.

General Description

Human Immunodeficiency Virus (HIV) can be divided into two major types, HIV type 1 (HIV-1) and HIV type 2 (HIV-2). HIV-1 is related to viruses found in chimpanzees and gorillas living in western Africa. The gag gene of HIV-1 encodes a precursor protein known as Pr55Gag. The viral protease PR cleaves this precursor to generate p17, p24, p7, and p6 proteins which are required for virus particle assembly. p24 is a major viral core structural protein, which is the main component of HIV virus and plays an important role in the process of virus reproduction. Usually, p24 protein can be detected in blood 2-3 weeks after HIV infection. Its measurement is commonly used as an indicator of HIV-1 infection and viral load. Therefore, it's helpful to develop the Human Immunodeficiency Virus type 1 (HIV-1) p24 ELISA Kit to quantitative detection the HIV-1 p24 antigen in cell culture fluid. To support the development of CAR-T drugs, CD independently developed HIV-1 p24 ELISA Residue Testing kit via rigorous methodological validation, which is used for detection of GMP Capsid protein p24 in samples from CAR-T product preparation processing for evaluation the quality of CAR-T products in drug development and CMC quality control stages.

Standard Curve

For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only. The sample concentration was calculated based on the results of the standard curve.