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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.


SEKBIO provides HIV diagnostics 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.

HIV Products


AntigenApplication
Mouse Anti-HIV p24 mAb

For immunodiagnostic: ELISA, LFA, CLIA

Humanized HIV p24 Antibody
HIV-1 Ag1 Recombinant Protein
HIV-2 Ag2 Recombinant Protein
HIV-2 Gp36 Recombinant Protein
HIV-1 Gp41 Recombinant Antigen
HIV-1 Gp41 (group O) Recombinant Antigen



AntibodyApplication
Mouse Anti-HIV p24 mAb

For immunodiagnostic: ELISA, LFA, CLIA

Humanized HIV p24 Antibody


The performance of our HIV Antigens

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.


Table 2: Interfering Substances



Analytes

Concentration

201204001

201204002

201204003


Plasma

Serum

Plasma

Serum

Plasma

Serum


Neg.

P-01

Neg.

S-07

Neg.

P-01

Neg.

S-07

Neg.

P-01

Neg.

S-07

Ascorbic Acid

20mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Hemoglobin

1000mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Bilirubin

1000mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Gentistic acid

20mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Acetoaminophen

20mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Acetosalisilyc acid (aspirin)

20mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Caffeine

20mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Oxalic Acid

60mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Uric acid

20mg/dL

-

+

-

+

-

+

-

+

-

+

-

+

Methonal

10%

-

+

-

+

-

+

-

+

-

+

-

+


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.


Table 3: Non Cross-Reacting Compounds



Treatment

Lot

201204001

201204002

201204003

15min

20min

15min

20min

15min

20min

hCG pregnancy 

-

-

-

-

-

-

HCV

-

-

-

-

-

-

Syphilis

-

-

-

-

-

-

HBsAg

-

-

-

-

-

-

Heterophilic

-

-

-

-

-

-

HAMA

-

-

-

-

-

-

RF factor

-

-

-

-

-

-


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 Ab/Ag

SEKBIO reagent

Total

Positive

Negative

Abbott I2000

Positive

30

1

31

Negative

0

29

29

Total

30

30

60



Performance on HIV 3rd generation Assay

On the ELISA platform, the results of the national plate are as follows:

 


Sample No.

Result

Sample No.

Result

Sample No.

Result

N1

0.006

P1

2.678

S1

0.006

N2

0.005

P2

2.595

S2

0.063

N3

0.006

P3

2.708

S3

0.149

N4

0.010

P4

2.462

S4

0.478

N5

0.011

P5

3.124

S5

0.882

N6

0.011

P6

1.034

S6

1.726

N7

0.010

P7

1.597

cv1

2.503

N8

0.013

P8

2.973

cv2

2.765

N9

0.005

P9

2.799



N10

0.005

P10

1.410



N11

0.006

P11

3.007



N12

0.008

P12

3.030



N13

0.004

P13

3.017



N14

0.005

P14

3.071



N15

0.006

P15

2.829



N16

0.001

P16

2.815



N17

0.009

P17

0.675



N18

0.196

P18

0.913



N19

0.005

P19

0.933



N20

0.010

P20

1.070






Performance on HIV 4th generation Assay

On the ELISA platform, the test results of our product for the Chinese HIV National panel are as follows:


Sample No.

Result

Sample No.

Result

Sample No.

Result

N1

0.006

P1

2.096

L1(20u)

1.69

N2

0.005

P2

1.163

L2(10u)

0.81

N3

0.006

P3

0.529

L3(5u)

1.391

N4

0.005

P4

2.122

L4(2.5u)

0.184

N5

0.003

P5

0.305

L5(1.25u)

0.103

N6

0.002

P6

1.211



N7

0.002

P7

2.655



N8

0.005

P8

1.908

NC

0.004

N9

0.004

P9

0.931

NC

0.004

N10

0.002

P10

2.152

NC

0.005

N11

0.005



PC-1

2.683

N12

0.005



PC-2

2.46

N13

0.002



PC-Ag

2.602

N14

0.004





N15

0.006





N16

0.006





N17

0.005





N18

0.004





N19

0.006





N20

0.005






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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