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

Antigen	Application
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

Antibody	Application
Mouse Anti-HIV p24 mAb	For immunodiagnostic: ELISA, LFA, CLIA
Humanized HIV p24 Antibody	For immunodiagnostic: ELISA, LFA, CLIA

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
HIV Ab/Ag		Positive	Negative	Total
Abbott I2000	Positive	30	1	31
Abbott I2000	Negative	0	29	29
Total		30	30	60

Performance on HIV 3^rd 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 4^th 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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