Antigen cardiolipin for microprecipitation reaction. Nonspecific serological diagnosis of syphilis Precipitation microreaction with cardiolipin antigen (rmp). Indications for use

Last update of the description by the manufacturer 31.07.1996

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Composition and form of release

A set of 5 ampoules of cardiolipin antigen containing 2 ml of the drug, and one bottle of choline chloride solution containing 5 ml of the drug; in the package 2 sets. 1 set is designed for 200-240 definitions.

Characteristic

A solution of three highly purified lipids: cardiolipin, lecithin, cholesterol in absolute ethyl alcohol. Transparent colorless solution with a specific smell of alcohol.

pharmachologic effect

pharmachologic effect— diagnostic.

Detection of antibodies to the causative agent of syphilis.

Indications for cardiolipin antigen for microprecipitation reaction (RMP)

Diagnosis of syphilis (study of active plasma or inactivated serum in the microprecipitation reaction).

Storage conditions Cardiolipin antigen for microprecipitation reaction (RMP)

In a place protected from light, at a temperature of 6-22 ° C.

Keep out of the reach of children.

Shelf life Cardiolipin antigen for microprecipitation reaction (RMP)

1 year.

Do not use after the expiry date stated on the packaging.

Price: on request

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Manufacturer: Microgen NPO FSUE

The country: Russia

Unit meas.: kit

Package: 10 ampoules

Packing type: cardboard box

Vendor code:

Description

A set of reagent solutions for diagnostic purposes: detection of antibodies to the causative agent of syphilis Treponema pallidum (treponema pallidum) in the microprecipitation reaction (RMP). Consists of 5 ampoules of solution containing cardiolipin antigen and 1 vial of choline chloride solution. Antigen titer not less than 1:8. The kit is designed for 1000 definitions, it is possible to supply a similar kit (from another manufacturer) for 500 definitions


Functional purpose

Designed for the diagnosis of syphilis in RMP with native blood plasma obtained from the patient's finger, or inactivated serum obtained from venous blood. The reaction is carried out in wells. The result of the reaction is taken into account visually, in the absence of spontaneous precipitation in the control setting. Flakes of various sizes are considered positive, which indicates the presence of an infection. A negative reaction in the form of opalescence is observed when the antigen interacts with the serum of healthy individuals.

PRODUCTION IS SUSPENDED UNTIL AUTUMN 2019.
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Specifications

Set composition:
1. Cardiolipin antigen for RMP - a clear, colorless solution of highly purified lipids: cardiolipin, lecithin, cholesterol in ethyl alcohol - 2.0 ml x 5 ampoules;
2. Choline chloride solution 70% - 5.0 ml x 1 vial;
3. Ampoule scarifier (when using ampoules with a ring or a break point, the scarifier is not inserted).
Release form: a set in a cardboard box along with instructions for use.
Storage conditions: at a temperature of +6...22°C in a dry, dark place, freezing is unacceptable.
Shelf life - 1 year from the production date indicated on the package, after which the reagent kit is not subject to use.
Registered with Roszdravnadzor (No. FSR 2012/13044)

Nomenclature of the Ministry of Health of the Russian Federation (Order No. 804n): A26.06.082.001 "Determination of antibodies to pale treponema (Treponema pallidum) in non-treponemal tests (RPR, RMP) (qualitative and semi-quantitative study) in blood serum"

Biomaterial: Serum

Deadline (in the laboratory): 1 w.d. *

The disease begins with the appearance of a painless ulcer at the site of the pathogen (hard chancre) and regional lymphadenitis. After some time, the infection becomes generalized: secondary and then tertiary syphilis develops.

Syphilis is a sexually transmitted disease caused by spirochete pallidum (Treponema pallidum). Spirochetes are thin, spiral

Indications for appointment

  • Diagnosis of syphilis

Study preparation

Special preparation for the study is not required.Blood sampling is carried out on an empty stomach or not earlier than 4 hours after a light meal. Permissible to drinkpure non-mineral and non-carbonatedwater. Tea, coffee, juice are prohibited.

Interpretation of results/Information for specialists

The result of the study is qualitative.

Reference values: not found.

Microprecipitation reaction (RMP) allows to detect antibodies to treponema cardiolipin antigen. RMP with isolated use is not a diagnostic, but a selection test, therefore, based on its positivity, the diagnosis of syphilis is not established, and the patient is given diagnostic tests (RCC, ELISA). With the help of RMP, people who are subject to periodic medical examinations for venereal diseases, patients with somatic diseases, etc. are examined.

RMP is positive in primary syphilis in 59-87% of cases, secondary - 100%, late latent - 79-91%, tertiary - 37-94%. RMP is usually negative in the first 7-10 days after the onset of a hard chancre.

To differentiate congenital syphilis from passive carriage of a maternal infection, newborns need to conduct a series of studies to determine the antibody titer: a rise in titer within 6 months after birth indicates congenital syphilis, while with passive carriage, antibodies disappear by the third month.

When evaluating the results of bladder cancer in infants with congenital syphilis, the prozone phenomenon must be kept in mind. The essence of this phenomenon is that for the agglutination of antigens and antibodies in these reactions, it is necessary that antigens and antibodies are present in the blood in appropriate quantities. When the number of antibodies greatly exceeds the number of antigens, agglutination does not occur. In some infants with congenital syphilis, serum antibody levels are so high that undiluted serum does not agglutinate antibodies and non-treponemal antigens used to diagnose syphilis (BCD is nonreactive). Therefore, in children examined for the diagnosis of congenital syphilis, the prozone phenomenon may occur.

False positive RMP can be:

  • in rheumatic diseases (SLE, rheumatoid arthritis, scleroderma);
  • infections (mononucleosis, malaria, mycoplasma pneumonia, active tuberculosis, scarlet fever, brucellosis, leptospirosis, measles, mumps, venereal lymphogranuloma, chicken pox, trypanosomiasis, leprosy, chlamydia);
  • pregnancy (rare);
  • in old age (about 10% of people over the age of 70 may have a false positive MR);
  • chronic lymphocytic thyroiditis, hemoblastosis, taking certain antihypertensive drugs, with hereditary or individual characteristics.

Most often ordered with this service

* The site indicates the maximum possible time for the study. It reflects the time of the study in the laboratory and does not include the time for the delivery of the biomaterial to the laboratory.
The information provided is for reference only and is not a public offer. For up-to-date information, contact the Contractor's medical center or call-center.

If syphilis is suspected, doctors prescribe a blood test for antibodies to the cardiolipin antigen. This assay is an improved version of the Wasserman (RW) reaction. In its classic form, the RW test has not been used for about 30 years. Nowadays, this study is carried out exclusively by immunological methods. What are the normal values ​​for this test? And how to correctly decipher its results? We will consider these questions in the article.

What it is?

Cardiolipin antigen is a lipid-like substance. In its composition, it is similar to the proteins of the causative agent of syphilis - pale treponema. Such a drug is used for the early diagnosis of this dangerous sexually transmitted disease. It allows you to identify pathology in the early stages.

Venous blood is taken for examination and mixed with cardiolipin antigen. The reaction of the interaction of the biomaterial and the drug is called If a person is healthy, then his blood does not produce antibodies to the antigen. If the patient suffers from syphilis, then class M and G immunoglobulins are actively formed in his body. In this case, flakes appear in the mixture of blood and the drug. This precipitate is a collection of antigen-antibody complexes (precipitate).

The formation of immunoglobulins in an infected person begins 7-10 days after the appearance of a chancre (painless ulcer) on the skin or mucous membrane. This is an early symptom of syphilis. Usually, the production of antibodies is observed 2-3 weeks after infection.

To conduct the test, use the "Cardiolipin antigen" kit. It is obtained from a bull's heart. The organ extract is mixed with cholesterol and lecithin. The resulting substance has similar properties to the proteins of pale treponema. It is able to cause the formation of immunoglobulins when reacting with the blood of a patient with syphilis.

Indications

Analysis with cardiolipin antigen is prescribed in the following cases:

  • in the presence of unprotected sexual contacts of the patient with casual partners;
  • at household contacts with patients with syphilis;
  • with symptoms of the primary and secondary stages of syphilis (chancre, rashes on the body);
  • with suspicion of neurosyphilis (mental and neurological disorders);
  • children born to infected women;
  • to monitor the effectiveness of antisyphilitic therapy.

This test is not always informative in advanced (tertiary) forms of pathology. In the later stages of syphilis, antibody production is significantly reduced.

A test with cardiolipin antigen must be taken during pregnancy. In addition, such a study is required for donors and people who draw up a medical book.

How is the research done?

It is very important to carefully prepare for the analysis. This test often gives false positive results. Two days before donating blood, you must completely exclude:

  • the use of alcoholic beverages (even low alcohol);
  • taking drugs with digitalis;
  • fatty food.

The analysis should be taken in the morning on an empty stomach. 8-10 ml of venous blood is taken for the study. Test results are usually ready in 1-2 days.

Norm

If the patient does not suffer from syphilis, then his blood does not react with the cardiolipin antigen. A negative test result in most cases means that the person is healthy. In the transcript of the test, this is indicated by the sign "-" or "RW-". This is considered the norm.

However, even with negative test results, it cannot be completely ruled out that a person is infected with treponema pallidum. After all, antibodies are not produced during the incubation period of pathology. Very weak production of immunoglobulins is also observed in the tertiary form of syphilis. Therefore, if a person with a negative Wasserman reaction has signs of pathology, then the analysis is prescribed again.

Possible deviations

Consider the decoding of the analysis. The severity of a positive reaction is indicated in the form with the results of the test with "+" signs. The following test data are considered abnormal:

  • "+" - a doubtful result (it is recommended to retake the analysis).
  • "++" - weakly positive reaction.
  • "+++" — positive result.
  • "++++" is a sharply positive test.

What to do if the test with cardiolipin gave positive results? The diagnosis of "syphilis" is usually not made only by the Wasserman reaction. In this case, doctors always prescribe additional studies.

This test in 70% of cases reveals the primary stage of syphilis, and in 100% of cases shows the secondary form of the disease. However, positive test results do not always indicate infection with treponema pallidum. Many factors can influence the data of this analysis. They will be discussed next.

False results

Often there are cases when the Wasserman test shows the formation of antibodies, but the person does not suffer from syphilis. A false positive reaction is noted in the following diseases and conditions:

  • pregnancy;
  • infectious mononucleosis;
  • gout;
  • diabetes mellitus;
  • malaria;
  • measles;
  • scarlet fever;
  • brucellosis;
  • pneumonia;
  • chlamydia;
  • mycoplasma infection;
  • viral hepatitis;
  • tuberculosis;
  • malignant tumors;
  • thyroiditis;
  • autoimmune diseases (systemic lupus erythematosus, scleroderma, rheumatoid arthritis);
  • infection with enteroviruses;
  • recent vaccination;
  • in senile patients (in 10% of cases);
  • alcohol consumption on the eve of the study;
  • drug addiction.

It can be concluded that the list of diseases and conditions in which false test results are noted is quite extensive. Therefore, to make an accurate diagnosis, an immunofluorescent blood test is prescribed. It allows you to more reliably detect the presence of immunoglobulins G to pale treponema. A blood test is also carried out by PCR diagnostics. It shows the presence of DNA fragments of pale treponema in the patient. The doctor makes the final diagnosis only on the basis of a comprehensive study.

Price: on request

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Manufacturer: EcoLab

The country: Russia

Unit meas.: package

Packing type: cardboard box

Vendor code: 03.07.3

Description

A set of reagents Syphilis-AgCL-RMP is used in the diagnosis of syphilis for the study of plasma (serum) of blood or cerebrospinal fluid (CSF) of a person in the microprecipitation reaction (RMP). Designed for the study of 2000 samples, the kit can be additionally equipped with positive and negative control sera (03.07.3k). The principle of the method is based on the interaction of the cardiolipin antigen (AgCL), similar to the Treponema pallidum lipoprotein antigen, with the corresponding antibodies (reagins), which appear in the plasma (serum) of untreated patients after 2-3 weeks, and in the cerebrospinal fluid after 4-8 weeks. weeks after infection


Functional purpose

Qualitative on glass and semi-quantitative for positive or weakly positive specimens. Visual registration of results. The interaction of AgCL with reagins leads to a microprecipitation reaction (falling out of flakes of different sizes is a positive result), with plasma or inactivated serum from healthy individuals, a negative reaction is observed in the form of opalescence

Specifications

Complex of lipids for performing the flocculation test for Luis (Lewis).
Kit composition: suspension of AgCL in 10% choline chloride solution containing cardiolipin - 0.033%; lecithin - 0.27%, cholesterol - 0.9%, EDTA (stabilizer) at a final concentration of 0.0125 mol / l and thimerosal (preservative) at a final concentration of 0.1%. Ready to use.
Appearance: milky-white suspension, which, upon standing, separates into an opalescent colorless liquid and a dense white precipitate.
Packaging: 7 bottles of 10 ml each.
The reagent is ready to use, bottled in screw cap vials.
The set is designed for the study of 2000 samples.
Test sample volume: 90 µl.
Sample for research: serum (plasma) of blood, cerebrospinal fluid.
The total reaction time is 8 minutes. The optimal temperature regime of the reaction is +23...28°С.
Expiry date - 18 months.
The shelf life of the kit reagents after opening the package is until the end of the expiration date.
Possibility of documentation, registration and automatic accounting during analysis on the hardware-software complex "Expetr-Lab RMP".
Transportation is allowed at a temperature of +9...25°C for 10 days.
Registered in Roszdravnadzor of the Russian Federation

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