Product Description

blood grouping test kits HIV ELISA KIT

Packaging & Shipping&Delivery

Product Description
1.Manufacturer:Low price,OEM service Approved
2.Certificates: GMP,ISO***1,ISO****5
3.Sample: Free
4.High Accurancy

Intended use

This is a 4th-generation assay for the simultaneous detection of antibodies to HIV*1 and HIV 2 as well as p*4 antigen of HIV*1. The assay is based on recombinant and synthetic peptides for antibody detection and monoclonal antibody specific to the p*4 protein of HIV*1. It has great significance in the diagnosis of HIV infection / screen for donated blood to prevent transmission of HIV to recipients and as an aid in clinical diagnosis of HIV-related infections.

REAGENTS

Materials provided with the kits:

RESULTS

1. For the assay to be valid, the mean OD value of Negative Controls must be less than or equal to 0.1 and

the mean OD value of Positive Controls must be greater than or equal to 0.8.

2. Cut-Off value = 0.**0+NC

NC= the mean absorbance value for two Negative Controls

3. Calculate the S/CO value. The mean signal to cut-off ratio (S/CO) is defined as the Mean Sample

Absorbance divided by the calculated Cut-Off value.

4. S/CO ³1, it is positive for HIV*1*2 antibody or HIV*1 P*4 antigen.

S/CO <1, it is negative for HIV*1*2 antibody and HIV*1 P*4 antigen.

SPECIFIC PERFORMANCE CHARACTERISTICS

Sensitivity

The sensitivity studies have been evaluated by using the national reference panel of HIV*1 P*4 Antigen

prepared by National Institute for the Control of Pharmaceutical and Biological Products (China), the minimal concentration of detection is *0pg/ml.

Specificity

The specificity has been determined on blood donors’ samples (****5 samples tested) and on

hospitalized patients (***2 samples tested). The specificity calculated is respectively *9.*0%

((*******9/****5)×**0%) and *9.*9% ((*****4/***2)×**0%).

Precision

Assay reproducibility was determined by assaying 3 samples in replicates of *0 on 2 consecutive runs

using the same production lot. The Intra-assay and Inter-assay standard deviation (S.D.) and the coefficient

of variation (%CV) were calculated.

The expected value of the CV is not higher than *5%.

Our Services

1. Samples: we offer free samples, but we don't charge the freight

2. OEM services: we accept customized services

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