HIV

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.

SEKBIOprovides anti hiv antibodyproducts: 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)/ = 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+ andRF factor+specimens specimens were confirmed by ELISA test and clinical diagnostic result and tested with theHIV 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 3below.

Conclusion: There was no cross-reaction withhCG pregnancy, HCV+,Syphilis, HBsAg+, Heterophilic, HAMA+ andRF 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, SEKBIOassay 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. Because the first two methods are complex and require special equipment and professional technicians, only antigen detection and RT-PCR (reverse transcription-PCR) can be used for clinical diagnosis.

2 Antibody detection

HIV antibody in serum is an indirect indicator to judge HIV infection. According to their primary scope of application, existing HIV antibody detection methods can be divided into screening tests and confirmatory tests.

3 Confirmation reagents

Western blot (WB) is the most commonly used method for confirming positive serum in screening experiments. Since this method has a relatively long window period, slightly poor sensitivity, and high cost, it is only suitable for confirmatory experiments. With the improvement of the sensitivity of the third and fourth-generation HIV diagnostic reagents, WB has become more and more unable to meet the requirements of confirmatory experiments.

Another FDA-approved screening confirmatory reagent type is an immunofluorescence assay (IFA). The cost of IFA is lower than that of WB, the operation is relatively simple, and the whole process can complete within 1-1.5 hours. The main disadvantage of this method is that it requires expensive fluorescence detectors and experienced professionals to observe the evaluation results, and the experimental results cannot store for a long time. The FDA now recommends that a negative or positive IFA prevail when issuing final results to blood donors who WB cannot determine, but not as a blood qualification standard.

4 Screening tests

The screening test is mainly used to screen blood donors, so it requires a simple operation, low cost, and sensitivity and specificity. At present, the primary screening method in the world is still ELISA, and there are a few particle agglutination reagents and rapid ELISA reagents.

ELISA has high sensitivity and specificity and is easy to operate. It is especially suitable for large-scale screening in the laboratory. It only needs a microplate reader and a plate washer to be applied in the laboratory.

Particle agglutination test is another simple, convenient, and low-cost detection method. The results of this method can be judged by the naked eye and have high sensitivity. It is especially suitable for developing countries or when screening many blood donors. The disadvantage is that it must use fresh samples, poor specificity.

The dot-blot assay developed in the late 1980s is a rapid ELISA (Rapid ELISA) method. This method is straightforward to operate, and the process is short. Most of the whole process is completed within 5-10 minutes or even 3 minutes. But this method is much more expensive than ELISA and particle agglutination reagents.

Gold immunoassay is a solid-phase immunoassay using colloidal gold as a marker and a nitrocellulose membrane as a carrier. It is divided into two forms: diafiltration and chromatography. Gold test strips used for HIV antibody samples belong to gold immunochromatography, and most of them are indirect methods and double antigen sandwich methods. Both approaches have advantages and disadvantages, but they are fast and straightforward, and conclusions can draw in a few minutes. No equipment is required, no special training is needed for operators, and the reagents are stable, suitable for single determination, etc.

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