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HIV

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Produktbeskrivelse

The human immunodeficiency virus, also known as HIV, is a retrovirus that causes human cellular immune system defects.

The virus attacks and gradually destroys the human immune system, leading to pathogenic bacteria and rare tumors, with fast infection and a high fatality rate.

SEKBIO provides anti hiv antibody products: Mouse anti -HIV p24 mAb, Humanized HIV p24 antibody, HIV-1 ag1 recombinant protein, HIV-1 ag2 recombinant protein, HIV-2 gp36 recombinant protein, HIV-1 gp41 recombinant antigen, HIV-1 gp41 (group O) recombinant antigen.

The performance of our HIV markers

Performance Evaluation

Clinical Performance

The specimen correlation study was performed on 1717 specimens. 555 positive specimens and 1162 negative specimens were confirmed by EIA. Specimens were rated either positive or negative at 15 minutes and 20 minutes. The results are shown in Table 1.

Table 1: Specimen Correlation Studies

EIA

HIV 1/2

Test Device + -

+ 554 4

- 0 1159

Positive agreement with EIA: 554/(554+0) > 99.9%

Negative agreement with EIA: 1159/(1159+4) = 99.6%

Total agreement with EIA: (554+1159)/ (554+4+1159) = 99.8%

Interfering Substances

Analytes were spiked into negative plasma and serum pools (ELISA confirmed) and low positive plasma and serum specimens (ELISA confirmed) at the concentrations listed. The specimens were tested in triplicate with 3 lots of test devices. Visual interpretations were made at 15 and 20 minutes after specimen application. The results are presented in Table 2 below.

Conclusion: No substances showed any interference with the test. There were no differences observed between the results at 15 minutes and the results at 20 minutes. 

Cross-Reactivity

HCG pregnancy, HCV+, Syphilis, HbsAg+, Heterophilic, HAMA+ and RF factor+ specimens specimens were confirmed by ELISA test and clinical diagnostic result and tested with the HIV 1/2 Rapid Test Device (Whole Blood/Serum/Plasma). Visual interpretations were made at 15 and 20 minutes after specimen application. The results are presented in Table 3 below.

Conclusion: There was no cross-reaction with hCG pregnancy, HCV+, Syphilis, HBsAg+, Heterophilic, HAMA+ and RF factor+ specimens at 20minutes.

A total of 10 sets of BBI positive control sera were tested on the chemiluminescent immunoassay platform. The evaluation was conducted by comparing with the Abbott I2000 reagents. Out of the 60 serum samples tested using the BBI positive control sera, SEKBIO assay detected 30 out of 60 samples, while the Abbott I2000 reagents detected 31 out of 60 samples. The positive agreement rate was 96.8%, the negative agreement rate was 100.0%, and the overall agreement rate was 98.3%.

HIV Antibody

HIV antibodies are effective against HIV.

The body's response to HIV is to produce antibodies to fight the virus. All people with HIV have antibodies in their bodies, but in most cases, antibodies cannot neutralize or kill different strains of the virus. Only a few broad-spectrum neutralizing antibodies can pass through the protective layer around HIV to kill the virus. HIV has a sugar-coated shell that blocks antibodies.

Broadly neutralizing antibodies offer the hope of regaining immunity in those who lack specific immune functions, and they can penetrate the sugar coat and potentially kill HIV efficiently in a shorter period.

HIV Antibody Test

HIV antibody test: The detection of HIV antibodies in the blood is the most commonly used laboratory method to detect HIV infection. Generally, it goes through two steps: first, a preliminary screening test is performed, and if it is positive, a confirmation test is performed, and a confirmation test is performed. Only positive can be diagnosed as HIV infection.

Commonly used methods are:

1 Pathogen detection

Pathogen detection mainly refers to the direct detection of viruses or virus genes from host specimens by virus isolation and culture, electron microscope morphological observation, virus antigen detection, and gene determination.