What does HIV agate analysis mean 1 2. Modern methods for diagnosing HIV infection

Timely diagnosis of HIV infection becomes an extremely important measure, since earlier treatment can largely determine the further development of the disease and prolong the life of the patient. AT last years Significant progress is being made in the field of detecting this terrible disease: the old test systems are being replaced by more advanced ones, examination methods are becoming more accessible, and their accuracy is significantly increased.

In this article, we will talk about modern methods for diagnosing HIV infection, which are useful to know for timely treatment of this problem and maintaining the normal quality of life of the diseased.

Methods for diagnosing HIV

In Russia, for the diagnosis of HIV infection, a standard procedure is carried out, which includes two levels:

• ELISA test system (screening analysis);
• immune blotting (IB).

Other diagnostic methods can also be used:

• express tests.

ELISA test systems

At the first stage of diagnosis, a screening test (ELISA) is used to detect HIV infection, which is based on HIV proteins created in laboratories that capture specific antibodies produced in the body in response to infection. After their interaction with the reagents (enzymes) of the test system, the color of the indicator changes. Further, these color changes are processed on special equipment, which determines the result of the analysis performed.

Such ELISA tests are able to show results within a few weeks after the introduction of HIV infection. This analysis does not determine the presence of the virus, but detects the production of antibodies to it. Sometimes, in the human body, the production of antibodies to HIV begins after 2 weeks after infection, but in most people they are produced for more than later dates after 3-6 weeks.

There are four generations of ELISA tests with different sensitivities. In recent years, III and IV generation test systems have been more frequently used, which are based on synthetic peptides or recombinant proteins and have greater specificity and accuracy. They can be used to diagnose HIV infection, monitor HIV prevalence, and ensure safety when testing donated blood. The accuracy of III and IV generation ELISA test systems is 93-99% (more sensitive are the tests that are produced in Western Europe - 99%).

To perform an ELISA test, 5 ml of blood is taken from the patient's vein. Between the last meal and the analysis should be at least 8 hours (as a rule, it is performed in the morning on an empty stomach). Such a test is recommended to be taken no earlier than 3 weeks after the alleged infection (for example, after unprotected intercourse with a new sexual partner).

The results of the ELISA test are obtained after 2-10 days:

• negative result: indicates the absence of HIV infection and does not require a referral to a specialist;
• false negative result: can be observed on early dates infection (up to 3 weeks), in the late stages of AIDS with severe immune suppression and with improper blood preparation;
• false positive result: it can be observed in some diseases and in case of improper blood preparation;
• positive result: indicates infection HIV infection, requires an IB and the patient's referral to a specialist at the AIDS Center.

Why can an ELISA test give false positive results?

False-positive results of an ELISA test for HIV can be observed with improper processing of blood or in patients with such conditions and diseases:

• multiple myeloma;
• infectious diseases provoked by the Epstein-Barr virus;
• state after ;
• autoimmune diseases;
• against the background of pregnancy;
• condition after vaccination.

For the reasons described above, non-specific cross-reacting antibodies may be present in the blood, the production of which was not provoked by HIV infection.

In recent years, the frequency of false positive results has significantly decreased due to the use of III and IV generation test systems, which contain more sensitive peptide and recombinant proteins (they are synthesized using in vitro genetic engineering). After the use of such ELISA tests, the frequency of false positive results has significantly decreased and is about 0.02-0.5%.

Revealing is false positive result does not mean that a person is infected with HIV. In such cases, WHO recommends another ELISA test (mandatory IV generation).

The patient's blood is sent to a reference or arbitration laboratory marked "repeat" and tested on a IV generation ELISA test system. If the result of the new analysis is negative, then the first result is recognized as erroneous (false positive) and IB is not carried out. If the result is positive or doubtful during the second test, the patient is required to undergo IB in 4-6 weeks to confirm or refute HIV infection.

immune blotting

The final diagnosis of HIV infection can only be established after a positive result is obtained. immune blotting(IB). For its implementation, a nitrocellulose strip is used, on which viral proteins are applied.

Blood sampling for IB is performed from a vein. Then it is subjected to special treatment and the proteins contained in its serum are separated in a special gel according to their charge and molecular weight (the manipulation is carried out on special equipment under the influence of an electric field). A nitrocellulose strip is applied to the blood serum gel and blotting (“blotting”) is carried out in a special chamber. The strip is processed and if the materials used contain antibodies to HIV, they bind to the antigenic bands on IB and appear as lines.

IB is considered positive if:

• according to American CDC criteria - there are two or three lines gp41, p24, gp120 / gp160 on the strip;
• according to American FDA criteria - there are two lines p24, p31 and a line gp41 or gp120 / gp160 on the strip.

In 99.9% of cases, a positive IB result indicates HIV infection.

In the absence of lines - IB is negative.

When identifying lines with gp160, gp120 and gp41, IB is doubtful. Such a result can be detected when:

• oncological diseases;
• pregnancy;
• frequent blood transfusions.

In such cases, it is recommended to perform a second study using a kit from another company. If, after additional IB, the result remains doubtful, then follow-up is necessary for six months (IB is performed every 3 months).

polymerase chain reaction

The PCR test can detect the RNA of the virus. Its sensitivity is quite high and it allows detecting HIV infection as early as 10 days after infection. In some cases, PCR can give false positive results, because its high sensitivity can also react to antibodies to other infections.

This diagnostic technique is expensive, requires special equipment and highly qualified specialists. These reasons do not allow it to be carried out during mass testing of the population.

PCR is used in such cases:

• to detect HIV in newborns who were born to HIV-infected mothers;
• to detect HIV in the "window period" or in case of doubtful IB;
• to control the concentration of HIV in the blood;
• for the study of donor blood.

Only by the PCR test, the diagnosis of HIV is not made, but is carried out as additional method diagnostics to resolve disputes.

Express Methods

One of the innovations in HIV diagnostics has become rapid tests, the results of which can be assessed in 10-15 minutes. The most efficient and accurate results are obtained with immunochromatographic tests based on the principle of capillary flow. They are special strips on which blood or other test fluids (saliva, urine) are applied. In the presence of antibodies to HIV, after 10-15 minutes, a colored and control strip appears on the test - a positive result. If the result is negative, only the control line appears.

As with ELISA tests, rapid test results should be confirmed by IB analysis. Only then can a diagnosis of HIV infection be made.

There are express kits for home testing. The OraSure Technologies1 (USA) test is FDA approved, available without a prescription, and can be used to detect HIV. After the test, in case of a positive result, the patient is recommended to undergo an examination in a specialized center to confirm the diagnosis.

The remaining tests for home use have not yet been approved by the FDA and their results can be very questionable.

Despite the fact that rapid tests are inferior in accuracy to IV-generation ELISA tests, they are widely used for additional testing of the population.

You can get tested for HIV infection at any polyclinic, the Central Regional Hospital or at specialized AIDS centers. On the territory of Russia, they are held absolutely confidentially, or anonymously. Each patient can expect to receive medical or psychological advice before or after the analysis. You will only have to pay for HIV tests in commercial medical institutions, and in public clinics and hospitals they are performed free of charge.

For information on how you can get HIV infection and what myths exist about the possibilities of getting infected, read

1 Set assignment

1.1 The kit is designed for the simultaneous detection of antibodies to the human immunodeficiency virus of the first and second types (HIV-1 and HIV-2) and the HIV-1 p24 antigen in human serum and plasma “in vitro” by indirect enzyme-linked immunosorbent assay.

2 Characteristics and principle of operation of the set

2.1 Set composition:

2.2 The main components of the "ELISA-HIV 1.2 AGAT" kit are immunosorbent, conjugate solution No. 1 and conjugate No. 2.

Immunosorbent is a polystyrene tablet, in the wells of which a mixture of recombinant HIV-1 (gp41) and HIV-2 (gp36) antigens and monoclonal antibodies to HIV-1 p24 antigen is adsorbed.

Conjugate solution #1 is a mixture of biotin-labeled monoclonal human antibodies against HIV-1 p24 antigen and biotin-labeled recombinant HIV-1 and HIV-2 proteins.

Conjugate #2 is streptavidin conjugated with horseradish peroxidase.

Positive control sample AT- human blood serum containing antibodies to HIV-1 and HIV-2, not containing antibodies to the hepatitis C virus and Treponema pallidum, HIV-1 p24 antigen and HBs antigen, inactivated by heating for 3 hours at a temperature of 56 ºC.

Positive control sample AG– human blood serum containing the native p24 HIV-1 antigen, not containing antibodies to HIV-1, HIV-2, hepatitis C virus and Treponema pallidum and HBs antigen, inactivated by heating for 3 hours at a temperature of 56 ºC.

Negative control sample– human blood serum that does not contain antibodies to HIV-1, HIV-2, HCV, HIV-1 p24 antigen and HBs antigen, inactivated by heating for 3 hours at a temperature of 56 ºC.

The principle of operation of the set. When a solution of conjugate No. 1 and serum samples of infected blood are introduced into the wells of the tablet, the p24 antigen binds both to specific antibodies on the solid phase and to monoclonal biotinylated anti-p24 antibodies that are part of the conjugate solution No. 1; HIV-specific antibodies bind both to the recombinant HIV-1 and HIV-2 antigens adsorbed on the solid phase, and to the antigens included in the conjugate solution No. 1, forming antigen-antibody complexes. Immune complexes of anti-p24 specific antibodies and p24 antigen are detected by conjugate No. 2. After washing off the unbound components, a solution of peroxidase substrate (hydrogen peroxide) and TMB chromogen is added to the wells of the plate.

The peroxidase reaction is stopped by adding a stop reagent (0.9 M sulfuric acid solution) and the color intensity of the solution in the wells is measured on a spectrophotometer as an optical density (OD) value at a wavelength of 450 nm.

The OD value is directly proportional to the concentration of specific antibodies and/or p24 antigen in a serum or plasma sample. The higher the content of antibodies and/or p24 antigen in the serum sample, the higher the staining intensity.

2.3 The set is designed to hold to hold 24 productions ELISA: 1 setting - 1 strip (8 holes). Total - 192 definitions including control samples.

3 Precautions when using the kit

3.1 All components of the kit in the concentrations used are non-toxic. However, work with all investigated samples of human serum (plasma) that should be considered as potentially infectious, capable of storing and transmitting HIV, hepatitis B virus or any other pathogen viral infection, with spent solutions and liquids, various equipment that may be contaminated during the analysis, requires certain safety measures when using the kit:

Work must be carried out in a specially equipped room;

It is necessary to work with the use of personal protective equipment and with the observance of precautions in accordance with the requirements of , , and .

3.2 Stop reagent containing sulfuric acid is irritating. In case of contact with skin and mucous membranes, rinse immediately with plenty of water.

3.3 When working with the kit, workplaces must be provided with supply and exhaust ventilation.

3.4 All persons working in the laboratory with kits must undergo a mandatory medical examination in accordance with the requirements.

3.5 Dispose of medical waste and/or unused kits with expired validity must be carried out in accordance with the requirements.

4 Rules for working with a set

4.1 To exclude false results, test samples must be prepared and stored under conditions that prevent bacterial growth. Serum samples containing aggregated serum components or sediment should be clarified by centrifugation for (5-10) minutes at 3000 rpm. Serum samples can be stored at (2-8) °C for no more than 5 days. Frozen samples (preferably to a temperature of at least minus 20 °C) can be stored for no more than 1 year. Repeated freeze-thaw cycles of samples should be avoided.

It must be remembered that samples with hemolysis, hyperlipidemia, bacterial growth, as well as those stored for a long time without freezing are not suitable for analysis.

The reliability of the results depends on the following rules:

It is not allowed to use the kit after the expiration date, as well as mixing the components of kits from different series;

A separate container should be used for the preparation of each reagent;

Do not treat all utensils used for the preparation of reagents with disinfectants and detergents. If necessary, rinse with drinking water, and then rinse five times with distilled water;

To work with the TMB and RX chromogen, it is necessary to use separate containers for solutions, pipette tips, and dishes.

Care must be taken to thoroughly mix the reagents;

The time between filling and emptying the wells of the plate with solutions and reagents should be at least 30 s. It is not allowed to dry the wells at all stages of the ELISA setting;

When using the washer, keep an eye on the condition of the container for solution for washing the plate and connecting hoses: they should not show signs of bacterial or fungal growth;

It is necessary to use automatic pipettes with interchangeable tips, certified for the value of the average dose and the convergence of the pipetting results (error not more than 3%);

Dispensers and working surfaces should be treated with a solution with a volume fraction of ethyl alcohol of 70%. Do not use chloramine and other chlorine-containing substances;

It is recommended to use disposable pipette tips for handling test and control samples. Each serum sample, as well as kit reagents, must be collected with a separate tip.

When introducing into the wells of PK-1, do not touch the surface of the tablet and the solution in the wells with the pipette tip.

During the analysis, avoid direct sunlight on the working surface.

4.2 When opening and dissolving the lyophilized components, it is necessary to ensure that no dry matter remains on the lid and walls of the vials.

5 Equipment and materials required for analysis

5.1 Vertical scanning spectrophotometer, which allows measuring the optical density of solutions in the wells of the tablet at a wavelength of 450 nm;

Semi- or automatic device for washing tablets (washer);

Dry-air thermostat type TC-80 M2, maintaining a temperature of (37 ± 1) ° C, or similar in characteristics;

Single-channel automatic pipettes with interchangeable tips, allowing to take liquid volumes from 0.01 to 5.0 ml;

Pipettes 8-channel automatic with interchangeable tips, allowing you to select liquid volumes up to 0.5 ml;

Measuring cylinder with a capacity of 2000 ml;

Laboratory flask with a capacity of 2000 ml;

Glass bottles with a capacity of 20 ml;

Trays for reagents or Petri dishes (diameter 100 mm);

Cotton wool medical hygroscopic;

Filter paper;

Rubber surgical gloves;

Solution with a volume fraction of ethyl alcohol 70%;

Solution with a mass fraction of hydrogen peroxide 6%;

Deionized or distilled water;

Container for collecting solid waste;

Container for draining liquid waste.

6 Preparing for analysis

6.1 Remove the reagent kit from the refrigerator before analysis, open the lid of the box and keep the components of the kit at a temperature (18-25) °C for 30 min.

Mix all serum (plasma) samples and reagents thoroughly before analysis.

The reagent consumption of the test kit, which is determined by the number of strips used, is given in Table A.1 of Appendix A.

6.2 Preparation of the plate wash solution

Attention! Prepare the solution for washing the plate 15 minutes before the start of the analysis!

If the vial with FSB-T × 25 contains a precipitate, it must be heated before use at a temperature of (37 ± 1) ° C until the precipitate is completely dissolved. In a measuring cylinder with a capacity of 2000 ml, add the contents of the vial with FSB-T × 25, then add distilled water to the mark 1250 ml and gently mix the solution. The solution can be stored at (2-8) °C for 72 hours.

In the case of using one or more strips, shake the contents of the vial with FSB-T × 25 vigorously for (20-30) s, take the required volume of the solution (Table A.1) into a measuring cup or cylinder, add the required amount of distilled water and mix the solution . Unused FSB-T×25 can be stored in a closed vial at a temperature of (2-8) °C during the expiration date of the kit.

6.3 Immunosorbent preparation

The immunosorbent is ready for use.

Open the package and install the required number of strips on the frame. Store the remaining strips in a tightly closed bag with a desiccant at (2-8) °C for 3 months.

6.4 Preparation of K + AT, K - , RK-1, PP-K2, BRS and stop reagent

K + AT, K - , RK-1, RR-K2, BRS and stop reagent are ready for use.

Attention! Precipitation is possible in a vial with RK-1. The supernatant must be used for analysis.

Unused RK-1, PP-K2, BRS and stop reagent after opening the vials can be stored in closed vials at a temperature of (2-8) °C during the expiration date of the kit.

The rest of K + AT and K - after opening the bottle can be stored in closed bottles at a temperature of (2-8) ° C during the expiration date of the kit.

6.5 Preparation of K + AG solution

Attention! The K + AG solution should be prepared 15 minutes before the start of the analysis!

To restore lyophilized K + AG, before opening the vial, lightly tapping to shake off the particles adhering to the walls of the vial or stopper. Open the vial and place the cork upside down on a dry surface. Add 0.8 ml of distilled water to the vial. Close the vial with a cork, hold for 10 minutes at a temperature of (18-25) ° C and gently tilt and rotate the vial, mix its contents until completely dissolved, avoiding the formation of foam.

Reconstituted K + AG can be stored in a closed vial at a temperature of (2-8) °C for one month, at a temperature of minus 20 °C - for six months. A single freeze-thaw of the restored K + AG is allowed.

6.6 Preparation of Kg-2 solution in working dilution

Take the volume indicated in Table A.1 from the vial with Kg-2 and transfer it to the vial with PP-K2. Mix the contents of the vial thoroughly, avoiding the formation of foam.

If one or more strips are used, take the required amount of PP-K2 into a clean vial, add Kg-2 in accordance with Table A.1 and mix the solution without foaming.

Attention! Kg-2 solution in working dilution is prepared immediately before use! Kg-2 solution in working dilution can be stored for 15 minutes at a temperature of (18-25) °C. Use only a new reagent tray and new tips!

The rest of Kg-2 can be stored in a closed vial at a temperature of (2-8) °C during the expiration date of the kit.

6.7 Preparation of working substrate solution

The bottle with TMB chromogen must be heated before use at a temperature of (37±1)° C until complete dissolution of the crystals.

Take the volume indicated in Table A.1 from the vial with TMB chromogen and transfer it to the vial with BRS. Mix the contents of the vial thoroughly, avoiding the formation of foam.

If one or more strips are used, take the required amount of BRS into a clean vial, add the TMB chromogen in accordance with Table A.1 and mix the solution without foaming.

Attention! The working solution of the substrate is prepared immediately before use in a place protected from light! The solution can be stored for 20 minutes at a temperature of (18-25) ° C, protected from light.

The solution must be protected from light and contact with metals or metal ions. The substrate solution must be colorless before use. The dishes that will be in contact with the substrate solution during the reaction should be washed without the use of synthetic detergents. Use only a new reagent tray and new tips!

The rest of the TMB chromogen can be stored in a closed vial at a temperature of (2-8) °C during the expiration date of the kit.

7 Plate wash requirements

At all stages of washing, it is necessary to control the filling of all wells and the complete removal (aspiration) of liquid from them;

It is necessary at each washing to fill all the wells with a solution to the brim (0.30-0.35 ml per well), without overflowing and overflowing of liquid from neighboring wells;

Keep the wells filled with the plate wash solution for 30 s;

With each aspiration, carefully remove the remaining liquid from the wells by tapping the frame with the strips in an inverted position on the filter paper folded several times, placed on a sheet of polyethylene;

Poor washing of the plate leads to incorrect results.

8 Conducting analysis

8.1 In any two wells of the tablet add 0.07 ml(70 µl) K + AT, in the other two wells - by 0.07 ml(70 µl) K + AG, in three other holes - by 0.07 ml(70 µl) TO - .

Attention! When setting up ELISA on one strip, it is allowed to use two wells for K - - one well, for K + AT - one well, for K + AG - one well.

In the remaining wells of the tablet add 0.07 ml(70 µl) of the studied samples of human serum (plasma).

Attention! Each sample must be taken with a disposable tip!

8.2 Into all wells of the tablet over control samples and test samples of blood serum (plasma) straightaway contribute by 0.05 ml(50 µl) RK-1. Mix the contents of the wells by gently tapping the edges of the plate.

8.3 (37 ± 1) ° From within 60 min.

Attention! For (1-2) minutes before the end of incubation, prepare a Kr-2 solution in working dilution (section 6.6).

8.4 Remove the contents of the wells with the washer, then wash the wells of the plate with the plate wash solution (step 6.2) seven times.

8.5 Add to all wells of the plate 0.15 ml(150 µl) solution Kg-2 in working breeding (clause 6.6).

8.6 Seal the plate with a film or cover with a lid and incubate in a thermostat at a temperature (37 ± 1) ° From within 10 min.

8.7 Remove the contents of the wells of the plate with a washer, then wash the wells of the plates with the solution for washing the plate (section 6.2) seven times.

8.8 Introduce into all wells of the tablet 0.15 ml(150 µl) substrate working solution(clause 6.7).

When preparing a working solution of the substrate (clause 6.7) f lacon with TMB chromogen must be heated before use for (3-5) minutes at a temperature of (37± 1) ° C until the crystals are completely dissolved.

8.9 Seal the plate with a film or cover with a lid and incubate in a thermostat at a temperature (37 ± 1) ° FROM in a dark place for 15 minutes.

Attention! At the end of incubation in wells with serum samples containing antibodies to HIV-1 and/or HIV-2 and/or HIV-1 p24 antigen, the color of the solution will change from colorless to blue different intensity depending on the concentration of antibodies and/or antigen in the test serum sample.

8.10 Stop the peroxidase reaction by adding to all wells 0.05 ml(50 µl) stop reagent.

Attention! Wells with serum samples containing anti-HIV-1 and/or HIV-2 antibodies and/or HIV-1 p24 antigen will change the color of the solution from blue to yellow of varying intensity.

8.11 Not later than (1-2) minutes after stopping the reaction, determine the OD in the wells in the single-wave mode at a wavelength 450 nm.

9 Processing of analysis results

9.2 Results are only considered if:

The value of OPsr K - does not exceed 0.2 OE;

Each individual value of OP K - should not deviate from OPs K - more than 30%. If one of the three values ​​of OP K - goes beyond this limit, it should be excluded from the calculation of OPs K - . If two of the three ODK values ​​are outside this limit, the assay should be repeated on a new set of reagents;

The value of OPsr K + AT more than 1.0 OE;

The value of OPsr K + AG is more than 1.0 OE.

9.3 If the above conditions are met, calculate the critical value (OPcrit.), OE, according to the formula (1):

OPcrit. = OPsr K - + 0,14 (1).

10 Analytical and diagnostic characteristics

Sensitivity reagent kit ELISA-HIV 1.2 AGAT for detection of HIV-1 p24 antigen –

Specificity reagent kit ELISA-HIV 1.2 AGAT– 100% Standard AT(-)HIV. Standard panel of sera that do not contain antibodies to the human immunodeficiency virus of the first and second types (HIV-1,2) and HIV-1 antigen (p24). CJSC MBS.

11 Kit release form

11.1 The set is available in five configurations:

1 set 1P - manual analysis. The kit is designed for 12 ELISA runs on a collapsible plate: 1 run - 1 strip (8 holes). In total - 96 determinations, including control samples;

2 set 2M - manual analysis. The kit is designed for 2 ELISA runs on monolithic plates: 1 run - 1 plate. Total - 192 determinations, including control samples;

3 set 2P- manual analysis. The set is designed to hold 24 productions ELISA for 2 collapsible x tablets: 1 setting - 1 strip (8 holes). Total - 192 definitions, including control samples;

4 set A2M - analysis on an automatic analyzer. The kit is designed for 2 ELISA runs on monolithic plates: 1 run - 1 plate. Total - 192 determinations, including control samples;

5 set A2P - analysis on an automatic analyzer. The kit is designed for 24 ELISA runs on 2 collapsible plates: 1 run - 1 strip (8 holes). A total of 192 determinations, including control samples.

12 Storage and use conditions of the kit

12.1 The kit should be stored in a clean, protected from moisture and light room at a temperature of (2-8) ° C during the entire shelf life. Do not freeze kit components.

12.2 To obtain reliable results, strict adherence to the instructions for use of the kit is necessary.

12.3 Expiry date of the kit 12 months.

Annex A

Table A.1 - Consumption of reagents of the ELISA kit

Bibliography

Unique registry entry number

Registration number medical device

FSR 2011/10182

the date state registration medical device

Name of the medical device

A set of reagents "MilaLab-IFA-HIV-AGAT" enzyme immunoassay for detection of antibodies to human immunodeficiency viruses types 1 and 2 (HIV-1 and HIV-2), HIV-1 group O and HIV-1 p24 antigen according to TU 9398 -187-05941003-2017
consisting of: - Immunosorbent - a 96-well polystyrene plate collapsible to strips (or to wells), in the wells of which artificial antigens are sorbed - gp160, gp41, p31 HIV-1, gp41 HIV-1 group O, gp36 HIV-2 and antibodies to HIV-1 p24 antigen: kit 1 (1 tablet), kit 2 (2 tablets), kit 3 (5 tablets), - Conjugate-1: kit 1 (1 vial 1.2 ml), kit 2 (1 vial 1.2 ml), kit 3 (1 vial 3.6 ml or 3 vials 1.2 ml each), - Conjugate-2: kit 1 (1 vial 2.0 ml), kit 2 (1 vial 1.2 ml). 2.0 ml), set 3 (1 vial 4.0 ml or 2 vials 2.0 ml each), - RRK-1 - solution for diluting Conjugate-1: set 1 (1 vial 12.0 ml) , kit 2 (1 vial 12.0 ml), kit 3 (3 vials 12.0 ml each), - RRK-2 - solution for diluting Conjugate-2: kit 1 (1 vial 20.0 ml), kit 2 (1 vial 20.0 ml), kit 3 (2 vials 20.0 ml each), - K + AT - control positive sample containing antibodies to HIV: kit 1 (1 vial 2.0 ml) , kit 2 (1 vial 2.0 ml), kit 3 (1 vial 4.0 ml or 2 vials 2.0 ml each), - K + AG - con trol positive sample containing artificial p24 HIV-1 antigen: kit 1 (1 vial. 2.0 ml), kit 2 (1 vial 2.0 ml), kit 3 (1 vial 4.0 ml or 2 vials 2.0 ml), - K- - control negative sample: kit 1 ( 1 vial 2.5 ml), kit 2 (1 vial 2.5 ml), kit 3 (1 vial 5.0 ml or 2 vials 2.5 ml each), - PR - flushing solution: kit 1 (1 vial 50.0 ml), kit 2 (1 vial 120.0 ml), kit 3 (2 vials 120.0 ml each), - Stop Reagent: kit 1 (1 vial 25.0 ml ), kit 2 (2 vials of 25.0 ml), kit 3 (2 vials of 50.0 ml or 4 vials of 25.0 ml), - SB - substrate buffer solution: kit 1 (1 vial of 25 0 ml), kit 2 (1 vial 25.0 ml), kit 3 (2 vials 50.0 ml each or 3 vials 25.0 ml each), - TMB - solution containing 3.3", 5.5"-tetramethylbenzidine: kit 1 (1 vial 2.5 ml), kit 2 (1 vial 2.5 ml), kit 3 (2 vials 3.5 ml or 3 vials 2.5 ml) ml). Accessories: - covers for polystyrene 96-well plates: set 1 (1 pc.), set 2 (2 pcs.), set 3 (5 pcs.) or - protective films for ELISA plates: set 1 (2 pcs.) , set 2 (4 pcs.), set 3 (10 pcs.), - disposable tips: set 1 (16 pcs.), set 2 (32 pcs.), set 3 (80 pcs.), - plastic trays for liquid reagents: kit 1 (2 pcs.), kit 2 (4 pcs.), kit 3 (10 pcs.), - plastic bags with Zip-Lock lock: kit 1 (1 pc.), kit 2 (2 pcs.) , set 3 (3 pcs.).

Name of the organization - the applicant of the medical device

Location of the applicant organization of the medical device

Legal address of the applicant organization of the medical device

603014, Russia, Nizhny Novgorod, st. Comintern, 47

Name of the medical device manufacturer or medical device manufacturer

OOO "NPO "Diagnostic Systems"

Location of the organization-manufacturer of the medical device or organization-manufacturer of the medical device

603093, Russia, Nizhny Novgorod, st. Yabloneva, 22, PO Box 69

Legal address of the organization-manufacturer of the medical device or organization-manufacturer of the medical device