Instruments and reagent kits for ELISA produced in Russia Kundelsky R.V., Ph.D. General Director of CJSC Vector-Best-Europe - presentation. Helminths igg ifa best Main symptoms in children

Number of definitions 96 (48 in duplicates)
Working tablet format: striped 12x8, broken into 1 hole.
Sensitivity: 1.5 U/ml.
Measuring range: 0-400 U/ml.
The volume of the test sample is no more than 25 µl.
Standardization of conditions for carrying out an enzymatic reaction with chromogen in a thermostatic shaker at 37ºC.
Set contents:
1. Striped plate 12 x 8 wells, ready for use - 1 pc.
2. Calibration samples ready for use (0-400 U/ml) colored with varying degrees of intensity depending on the concentration - 6 bottles.
3. Control sample - 1 bottle.
4. One-component conjugate, ready for use, not requiring dilution - 1 bottle.
5. Solution for diluting serums - 1 bottle.
6. Chromogenic substrate, one-component - tetramethylbesidine plus (TMB+) solution, ready for use, not requiring dilution - 1 bottle.
7. Phosphate-buffered saline solution with Tween - 2 bottles.
8. Stop reagent, ready for use - 1 bottle.
9. Film for sealing the tablet - 1 pc.
10. Stencil for constructing a calibration graph - 1 pc.
11. Reagent bath - 2 pcs.
12. Pipette tips for 5-200 µl - 16 pcs.
The tablet is packaged in a teak ziplock bag.
The stability of the FST-T working solution is at least 5 days at a temperature of +2...8°C.
Store the kit at a temperature of +2...8°C. Shelf life - 1 year from the date of production.
Registered with Roszdravnadzor.

Treatment of helminthiasis in children is extremely important, since the consequences of this can be a lag in physical and mental development, pathological processes in internal organs and systems, even death. In addition, helminth infestations are very contagious, which is why they spread so easily in preschool and school institutions. Based on this, it is clear how important timely treatment of helminthiasis in children is.

The first signs of helminths in children

Worms are opportunistic agents of the human body, worms for which humans are the final host. In addition, the age of the owner does not play any role in this matter; different types of helminthiasis can be observed in both children and adult patients.

How dangerous is helminthiasis for a child?

As mentioned earlier, helminths in children can cause serious diseases and pathologies, as a result of which mental and physical development slows down. Possible complications for each type of helminthiasis can be completely different, for example:

Therefore, childhood helminthiasis requires even more attention, timely assistance from a doctor, long-term observation by a specialist, and prevention.

Main symptoms in children

Symptoms of helminthiasis in a child can be different, depending on the type of worms:

1. Roundworms immediately manifest themselves with an allergic reaction, fever and nausea in the child. The first appearances are usually bright, but quickly fade away. After which the following symptoms may be observed:

colic and dysbacteriosis and newborns;
in babies under 1 year of age, pain in the navel area, problems with stool, allergies and diathesis;
older children have problems sleeping, restless behavior, nightmares;
Children 3-7 years old are characterized by nausea, fever, coughing, abdominal pain, and rash.

2. Enterobiasis, caused by pinworms, manifests itself with a blurred clinical picture. And only after 1 month you can notice the following symptoms:

in newborns, inflammation, swelling and redness of the anus, refusal to eat, crying at night, lack of appetite;
children under one year of age experience the same symptoms, as well as severe itching of the anus at night (from 11 p.m. to 1 a.m.); girls suffer from inflammation of the genital organs;
in older children, pain in the abdomen near the navel, sleep disturbance, itching in the buttocks.

3. Symptoms of Toxocariasis are difficult to recognize, except for low body temperature and allergic reactions (rash, hives, itching and swelling). After infection, a cough may occur, which subsequently causes pneumonia or bronchitis, especially in the youngest patients.

Trichinosis assumes mild symptoms in newborns, otherwise the following symptoms are observed:

feverish condition;
swelling of the face;
muscle pain;
allergic reactions;
Children 5 years of age and older may experience enlarged tonsils, spleen, rash, and sore throat.

It is most difficult to diagnose the symptoms of helminthiasis in children 2 years of age and younger, since the child cannot explain his behavior and condition. Therefore, for any atypical manifestations and behavior of the child, it is better to show a doctor.

What should you do first?

Worms that were found in a child’s feces are the most important sign of the disease, after which you should immediately seek help from a doctor. No treatment for helminths can be successful without proper diagnosis. Examination methods in this case should be comprehensive, including the following procedures:

taking scrapings from the anus;
examination of the child's stool;
blood test;
muscle biopsy in rare cases when trichinosis is suspected;
serological blood test;
X-ray, ultrasound, tomography;
ELISA to detect antibodies in the blood.

Treatment methods

Treatment of helminthiasis in children should be comprehensive, well thought out, prescribed with precise dosages and frequency of drug administration. This is due to the fact that drugs with toxic components are used for the anthelmintic effect, which means that irrational use can lead to side effects. In addition, folk treatment with medicinal plants is appropriate at home.

Folk remedies

Modern treatment with folk remedies for such diseases for children involves 4 effective methods:

Any method of home treatment should be discussed in advance with your doctor. It must be remembered that herbs and folk remedies have contraindications in the form of individual intolerance.

Drug treatment

For enterobiasis and ascariasis, drugs such as Pyrantel and Mebendazole are usually used. Taking Pyrantel is appropriate in a dose of 10 mg of the substance per kilogram of weight for pinworms, and 5 mg/kg for roundworms. Mebendazole is taken twice a day, 50 mg for children 2-3 years old for three days in a row, two times 100 mg for three days in a row for children over 3 years old, after 3 weeks the therapy is repeated.
For toxocariasis, Mebendazole is prescribed in a different dose - for children 2 years of age and older, 100 mg twice a day for 14-10 days.
Trichinosis is treated with Mebendazole 5 mg per kilogram of weight, after which the dose is divided into three doses per day. The course of treatment is 1 week under strict medical supervision.

Prevention of helminthiases

washing hands immediately after contact with animals, after going outside and in sandboxes, going to the toilet and before eating;
eating only clean foods;
correctly carried out heat treatment of meat and fish products;
drinking boiled water;
maintaining personal hygiene and sanitation;
regular deworming of pets;
carrying out preventive deworming in children aged 2 years and older.

Blood test for toxocara

Features of human infection with toxocariasis

The carriers of the infection are dogs, less often cats. Toxocara eggs are spread in the feces of stray dogs. Once on the ground, in water or lingering on the fur of an animal, they are introduced into a healthy body in different ways.

Reaction to intrusion by a stranger

It is known from medical statistics that adults are less likely to become infected with toxocariasis, unless their occupation is at risk. Children are much more likely to get the infection.

The most common symptoms of toxocariasis:

Fever without signs of any disease.
Increase in temperature.
Increasing and fading pain in the head or stomach.
The appearance of a skin rash that cannot be eliminated.
Puffiness of the face.
An increase in the level of eosinophils in the blood, detected during a general analysis.

To make an accurate diagnosis, an immunological test for Toxocara is prescribed. The presence of protein compounds in the blood that carry the genetic information of the helminth (antigens) provokes the immune system to produce antibodies of the igg class. This is the first sign of toxocariasis infection.

Preliminary diagnosis

The initial stage of the patient's medical history is collective. Before sending a patient to take a blood test for toxocariasis, it is necessary to study the background of the disease and do a preliminary examination.

Primary diagnosis:

Study of aggravating circumstances that could provoke infection - specific work with animals or the presence of a pet, excavation work in a potentially dangerous area, children playing in dog-walking areas.
Physical examination of the patient. Examination of the skin for subcutaneous invasion by Toxocara, eyelids and eyeballs, palpation.
Prescribing a complete blood test. During infection with toxocariasis, a significant increase in some indicators is characteristic - eosinophils (70–80%), lymphocytes, ESR. While the hemoglobin level drops noticeably.
Taking liver samples. With severe invasion, the load on the liver is affected, which is manifested by a strong jump in bilirubin.

It is impossible to obtain direct confirmation of Toxocara infestation using conventional tests (blood, coprogram, smear). Duodenal examination is also uninformative, as it is difficult due to the migratory nature of the larvae.

After receiving the results of a preliminary examination indicating a possible infection with toxocariasis, and differentiating the alleged diagnosis from diseases with similar symptoms, the patient is prescribed an ELISA test for toxocariasis.

Enzyme immunoassay

The main goal of this study is to confirm the presence of Toxocara in the human body. Antibodies to these helminths are found in blood plasma, so it is taken from a vein.

Testing for Toxocara requires some preparation:

Do not eat fatty or heavy foods the day before the procedure.
Do not drink sweet, carbonated or alcoholic drinks during the day before visiting the laboratory.
Take samples on an empty stomach.
Do not take medications on the previous day and the day on which the test is scheduled.

It is necessary to take into account that this very informative method of identifying invasion may be affected by certain circumstances. A false positive result may occur if the patient has:

Oncological diseases.
Pulmonary tuberculosis.
Severe liver pathologies.
Autoimmune syndrome.
Antiphospholipid syndrome.
Pregnancy.

In this case, it will not be possible to obtain a 100% confirmatory analysis, since under the above circumstances the defense system also produces immunoglobulins (antibodies). It is necessary to conduct additional diagnostics and differentiate toxocariasis from the listed factors.

The concentration of immunoglobulins (titer) of the IgG class reaches its maximum possible value 2-3 months after the onset of invasion. The more severe the infection, the higher this indicator.

ELISA results

To make a diagnosis, an enzyme immunoassay is carefully studied, and the results obtained are compared with reference values. An antibody titer of 1:100 with a positivity index of less than 0.9 is considered normal.

Numerical values of titers

The results obtained may be negative, positive, weakly positive, or questionable. The number of AT titers depends on the severity of the invasion and how long ago it occurred.

Analysis transcript:

AT titer up to 1:100 – the result is negative. No Toxocara larvae were found in the patient's body.
AT titer up to 1:400 is a weakly positive result. The patient has a weak invasion or develops an ocular form of toxocariasis. In some cases, the indicator indicates a recent infection.
AT titer up to 1:600 – the result is positive. A person suffers from a clinical form of helminthiasis, which, if detected, requires immediate treatment.
AT titer up to 1:800 – the result is positive. It speaks of severe invasion of a progressive nature and a high probability of developing a pathological process of internal organs.

With rare exceptions, ELISA studies reveal an advanced form of invasion with an admixture of helminthiasis of another origin. In this case, total antibodies may be higher than 1:800.

Positivity rate

When performing an enzyme immunoassay for toxocariasis with a titer of 1:400 – 1:600 to differentiate invasion from side factors, the obtained indicators are compared with the reference value. The difference between these numbers is usually called the index or positivity coefficient.

Usually, in the ELISA form, one indicator is opposite the other. The first is the norm, the second can mean:

Up to 0.9 – the result is negative. No Toxocara larvae were found.
0.9-1.1 – the result is doubtful. In this case, repeated diagnostics are prescribed.
1.1-2.2 – the result is slightly positive. A person is a carrier with a weak invasion.
2.2-4.2 – the result is positive. Toxocariasis of moderate severity develops for quite a long time.
Over 4.4 – the result indicates the peak of helminthic infestation or recent helminthiasis.

A CP with a result of 4.4 and a detected increase in eosinophilia by 10% may indicate the development of the ocular form of toxocariasis and the presence of antibodies to cross-invasion, total to toxocariasis.

The immune response and optical density of antibodies (positivity rate) depend on the degree of infection with Toxocara and their location. The lowest titer and CP can only suggest the absence of helminths, but not confirm this.

The information presented cannot serve as a source for self-diagnosis or self-treatment. The results of ELISA in combination with a preliminary examination can only tell a specialist about the presence of a problem. In the Invitro laboratory, blood diagnostics are carried out with high accuracy; the analysis result is accompanied by comments from specialists about the positivity rate. This significantly helps the doctor make a more accurate diagnosis.

DRUGS

EVALUATION OF NEW ELISA TEST SYSTEM

"Rotavirus-antigen-ELISA-BEST"

12Zhirakovskaya E.V., 3Ignatiev G.M., 3Indikova I.N., 12Tikunova N.V.

1 Federal State Budgetary Institution State Scientific Center VB "Vector" of Rospotrebnadzor, Koltsovo village, Novosibirsk region;

2 Institute of Chemical Biology and Fundamental Medicine, Novosibirsk;

3 State Institute for Standardization and Control of Medical Biological Preparations named after. L.A. Tarasevichag Moscow

The results of tests of sensitivity, specificity and reproducibility of a new set of reagents “Rotavirus-antigen-ELISA-BEST” developed at JSC “Vector-Best” (Novosibirsk) are presented. The data obtained allow us to predict the diagnostic reliability of the results when using this test system to detect group A rotavirus antigen in clinical material.

Key words: ELISA test system, efficiency, rotavirus A

Group A rotaviruses (family Reoviridae, genus Rotavirus) are the most common cause of severe gastroenteritis in young children worldwide. Adults with weakened immune systems often also become ill. Rotavirus infection (RVI) is a highly contagious disease with multiple routes of spread. The source of infection is a person with a manifest or asymptomatic form of the disease, as well as a virus carrier. Among children and adults, RVI can manifest itself in the form of sporadic cases, local group diseases, outbreaks and is widespread. The fecal-oral mechanism of transmission of this infection is realized through food (milk and dairy products, baby food), water and contact-household routes.

Making a diagnosis of rotavirus gastroenteritis based on the clinical picture, especially with sporadic incidence, is a certain difficulty, since the symptoms characteristic of this infection differ little from the symptoms of other acute intestinal infections (AEI) of various etiologies. Differential diagnosis in patients with rotavirus gastroenteritis is carried out both with foodborne toxic infections and with other viral infections (noroviruses, astroviruses, adenoviruses, coronaviruses, Coxsackie and ECHO enteroviruses) and bacterial (salmonellosis, dysentery, cholera, yersiniosis, opportunistic microorganisms) etiology. Unfortunately, not all specialized medical institutions in the Russian Federation carry out diagnostics of rotavirus infection.

Diagnostic methods for RVI are aimed at detecting whole virions, viral antigen or virus-specific RNA in feces. A promising approach to the direct detection of viruses both in clinical material and in environmental objects is the reverse transcription-polymerase chain reaction (RT-PCR) method. In recent years, test systems have been created based on modern scientific developments with a combination of various methods for detecting rotaviruses: multiplex PCR with hybridization-fluorescence detection of amplification products “by end point”; endpoint immuno-PCR (IPCR) with real-time detection; quantitative RT-PCR with real-time detection. Research laboratories use electron microscopy to quickly identify rotaviruses. However, all of the above methods are quite labor-intensive and require expensive equipment and highly qualified personnel. Therefore, when conducting laboratory diagnostics in hospitals and outpatient settings, preference is given to methods based on the detection of viral antigen in feces using enzyme-linked immunosorbent assay (ELISA) with mono- and polyponal antibodies to rotaviruses. This method is available for practical laboratories, is easy to set up and allows you to quickly obtain results.

The purpose of this work is to study the diagnostic effectiveness of the new set of reagents “Rotavirus-antigen-ELISA-BEST” developed at JSC “Vector-Best”, Novosibirsk.

^September-December

Materials and methods

The study material included fecal samples from young children diagnosed with acute intestinal infection and without clinical manifestations of intestinal infection, who were undergoing inpatient treatment in the departments of intestinal infections and respiratory infections of the Children's City Clinical Hospital No. 3 of Novosibirsk. Fecal samples were collected in disposable sterile plastic containers in a volume of 2-3 ml upon admission of patients to the hospital department and stored at -20 °C for 15 days. Longer storage of the material was carried out at - 70 °C.

A panel of 104 fecal samples, previously tested for the presence of ACI pathogens, was used in this work. Of these:

30 samples in which only group A rotaviruses were detected by ELISA and RT-PCR; genotyping using the RT-PCR method showed that fecal samples contained rotaviruses of genotype PG1 (18 samples), PG2 (4 samples), PG3 (3 samples), PG4 (2 samples), PG4 (1 sample), PG9 (1 sample) , PG3 (1 sample);

14 samples in which only noroviruses of the second genotype were detected by RT-PCR, which was confirmed by determining the nucleotide sequence of the 5" region of the capsid gene located on the norovirus genome in the region 5085-5485 h.;

15 samples in which only astroviruses were identified by RT-PCR, which was confirmed by determining the nucleotide sequence of the 5" region of the capsid gene located on the astrovirus genome in the region 4526 - 4955 nt; 15 samples in which only adenoviruses were identified by PCR ;

30 fecal samples (control) from children without clinical manifestations of intestinal infection hospitalized in the respiratory department of the hospital; Preliminary analysis did not identify the above-mentioned viral pathogens in these samples.

Testing of samples for the presence or absence of rota-, noro-, astro- and adenoviruses was carried out using the RT-PCR method using commercial kits registered in the Russian Federation “AmpliSens No. virus 1, 2 genotypes - 306/322”, “AmpliSens Astrovirus -165”, “AmpliSens Adenovirus - 462”, “AmpliSens Rotavirus - 290” (produced by the Central Research Institute of Epidemiology, Russian Federation). The samples were examined in accordance with the instructions for use of the corresponding reagent kits during the expiration date. Rotavirus-positive samples were genotyped using RT-PCR. Determination of the presence or absence of rotavirus antigen was also carried out by ELISA using the commercial IDEIA™ Rotavirus test system (DakoCytomation, UK) in accordance with the instructions for the kit.

When testing the “Rota-virus-antigen-ELISA-BEST” reagent kit, all of the above samples (104) were encrypted and tested three times with the test kit. After testing was completed, the samples were decrypted and the results were analyzed.

Results and discussion

The sensitivity of the Rotavirus-antigen-ELISA-BEST reagent kit was assessed by the number of coincidences of positive results (in%) testing samples using the tested test system and reference drugs. At the same time, it was revealed that when using the “Rotavirus-antigen-ELISA-BEST” reagent kit, all 30 samples with the confirmed presence of rotavirus A were positive (Table 1). Consequently, the sensitivity of the test set of reagents in detecting rotaviruses A was 100%. It should be noted that the panel included samples with seven different genotypes of rotaviruses, and all of them were successfully detected by the “Rota virus rus - antigen - AND FA-B EST” reagent kit.

The specificity of the test system was assessed by the number of coincidences of negative results (in %) of testing samples using the tested test system with those submitted to preliminary studies. To assess the specificity, the panel used included 30 samples in which viral pathogens were not identified, as well as 14 samples in which only noroviruses of the second genotype were detected using the RT-PCR method, 15 samples in which the RT-PCR method detected only astroviruses; 15 samples in which only adenoviruses were detected by PCR. It was determined that in 69 of 74 negative samples, the optical density values when detected by the Rotavirus-Antigen-ELISA-BEST reagent kit for the presence of rotavirus A did not exceed the background values, that is, the values obtained as a result of measuring the optical density in control negative samples. Two samples containing astroviruses, one sample containing a norovirus of the second genotype, one sample containing an adenovirus, and two samples in which none of the above viral pathogens were detected demonstrated positive optical density readings. It should be noted that in samples in which none of the viral pathogens had previously been detected, positive signals were recorded in only one of the repeated studies (Table 2). Thus, the specificity of the Rotavirus-antigen-ELISA-BEST reagent kit was 93.2%.

During the tests, the reproducibility of the results obtained when using the test set of reagents “Rotavirus-antigen-ELISA-BEST” on clinical material was assessed - all samples were examined three times in different experiments to determine the variation in results. In almost all cases, similar results were obtained: the test system detected all negative and positive samples equally. The exceptions were two samples in which none of the viral pathogens had previously been identified: in one of the replicates for both samples, the optical density values exceeded the OPcrit. It should be noted that the excess was insignificant (Table 2). Thus, the reproducibility of the results was 98.8%.

The results of the tests showed that the tested set of reagents “Rotavirus-antigen-ELISA-BEST” in terms of its diagnostic effectiveness - specificity, sensitivity and reproducibility - is comparable to those available in the Russian Federation for diagnostics.

chemical test systems, which makes it possible to predict the diagnostic reliability of the results when using the studied set of reagents “Ro-tavirus-antigen-ELISA-BEST” to detect the group A rotavirus antigen in clinical material.

Literature

1. Bogomolov B.P. // “Infectious diseases: emergency diagnosis, treatment, prevention.” - M., New Diamed. - 2007.

2. Vasiliev B.Ya., Vasilyeva R.I., Lobzin Yu.V.// “Acute intestinal diseases. Rotaviruses and rotavirus infection.” - St. Petersburg, Lan. - 2000.

3. Zhirakovskaya E.V., Tikunov A.Yu., Bodnev O.A., et al.// “BIOpreparations”. - 2008 - No. 2. - p. 15 - 18.

4. Zhirakovskaya E.V., Maleev V.V., Bodnev A.S. and others // JMEI - 2008 - No. 4. - With. 12 - 16.

5. Ignatyuk T.E., Golutvin I.A., Nasikan N.S., et al. // “Questions of Virology”. - 2003. - t. 48. - No. 6. - p. 1721.

6. Novikova N.A., Fedorova O.F., Epifanova N.V., Chup-rova A.B. // “Questions of Virology”. - 2007. - t.52. -No. 3 - s. 19-23.

7. Podkolzin A.T., Mukhina A.A., Shipulin G.A., et al.//

"Infectious diseases". - 2004. - vol. 2. - No. 4. - p. 85 -91.

8. Podkolzin A.T., Fenske E.B., Abramycheva N.Yu., et al.// “Therapeutic Archive”. - 2007. - t. 79. - No. 11. - p. 10-16.

9. Sergevnin V.I., Voldshmidt N.B., Sarmometov E.V., et al. // “Epidemiology and infectious diseases”. -2004.-No. 6.-p. 17-20.

10. Sergevnin V.I., Voldshmidt N.B., Sarmometov E.V., et al. // Hygiene and Sanitation. - 2007. - No. 1. - p. 56 -58.

11. Arcangeletti M. S., De Conto E., Pinardi F., at al. // Acta Biomed. Ateneo. Parmense. - 2005. -V. 76(3). - P. 165 -170.

12.Gladstone B.P., Iturriza-Gomara M., Ramani S., at al. // Epidemiol. Infect. - 2008. V. 136(3). - P. 399-405.

13. Min B.S., NohYJ., Shin J.H., atal. //J. Virol. Methods. -2006. - V. 137 (2). - P. 280 - 286.

14. Santos N., Honma S., Timenetsky Mdo C., at al. //J. Clin. Microbiol. - 2008. V. 46 (2). - P. 462 - 469.

15. Schets F. M., van Wijnen J. H., Schijven J. F., at al. //Appl. Environ. Microbiol. - 2008. - V. 74 (7). - P. 2069 - 2078.

16. Stockman L.J., Staat M.A., Holloway M., at al. // J. Clin. Microbiol. - 2008. - V. 46 (5). - P. 1842 - 1843.

Evaluation of the sensitivity and specificity of the “Rotavirus-antigen-ELISA-BEST” reagent kit

Table 1

No. Number of samples Detection results with reference drugs IDEIA Rotavirus Astro-PCR Hopo 2-PCR Adeno-PCR Detection results with the “Rotavirus-antigen-ELISA-BEST” kit

1. 30 30 0 0 0 30

2. 15 0 15 0 0 2

3. 14 0 0 14 0 1

4. 15 0 0 0 15 1

Assessment of the specificity of the reagent kit “Rotavirus-antigen-ELISA-BEST>-

Table 2

PCR AmpliSense

rotavirus rotavirus rotavirus rotavirus

0,443 1,306 0,676 0,418

Rotavirus-antigen-ELISA-BEST JSC "Vector-Best"

OPCrit OPCrit OPCrit

0,250 0,263 0,251

> 4,000 > 4,000 > 4,000 3,926 > 4,000 3,939

> 4,000 > 4,000 > 4,000

£September

December 2009

AmpliSense

rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus rotavirus astrovirus astrovirus astrovirus astrovirus astrovirus astrovirus astrovirus

IDEIA Rotavirus DakoCytomation OPCrit = 0.150

0,401 0,322 1,659 0,566 0,518 1,278 1,285 0,809 1,160 0,407 0,218 0,703 1,889 1,069 1,302 0,879 1,842 0,747 0,793 1,013 1,124 0,670 0,726 0,683 0,814 0,997 0,206 0,052 0,050 0,034 0,040 0,048 0,040

Rotavirus-

OPCrit 0.250

> 4,000 3,933 3,987 3,918 3,853 3,972

> 4,000 3,864 3,879 3,897 3,800

> 4,000 3,981

> 4,000 3,713

> 4,000 4.000

> 4,000 3,989

> 4,000 3,872 0,088 0,103 0,230 0,240 0,268 1,819 0,062

antigen-ELISA-BEST "Vector-Best"

OPCrit OPCrit 0.263 0.251

> 4,000 > 4,000

> 4,000 > 4,000 3,821 3,899

> 4,000 3,964 3,845 3,923 3,962 3,871

> 4,000 3,929

> 4,000 3,881 3,884 > 4,000

> 4,000 > 4,000 3,800 3,851 3,818 >4,000

> 4,000 > 4,000

> 4,000 3,995

> 4,000 > 4,000

> 4,000 > 4,000 3,837 3,839

> 4,000 > 4,000

> 4,000 3,986

> 4,000 > 4,000

> 4,000 3,998

> 4,000 > 4,000

> 4,000 3,823 0,063 0,073 0,054 0,061 0,255 0,250 0,256 0,244 0,278 0,560 1,117 1,235 0,052 0,052

astrovirus astrovirus astrovirus astrovirus astrovirus astrovirus astrovirus astrovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus norovirus adenovirus adenovirus adenovirus adenovirus adenovirus adenovirus adenovirus adenovirus adenovirus adenovirus adenovirus

IDEIA Rotavirus DakoCytomation OIIKpHT = 0.150

0,043 0,043 0,041 0,052 0,040 0,046 0,041 0,040 0,037 0,039 0,030 0,045 0,032 0,030 0,037 0,042 0,034 0,039 0,043 0,043 0,045 0,039 0,050 0,034 0,050 0,043 0,050 0,042 0,041 0,042 0,038 0,047 0,039

PoTaBHpyc-aHTHreH-HOA-EECT 3AO “BeKTop-EecT”

OnKpHT OnKpHT OIIKpHT

0,250 0,263 0,251

0,115 0,075 0,082

0,053 0,046 0,058

0,233 0,198 0,189

0,144 0,105 0,128

0,243 0,062 0,073

0,043 0,040 0,046

0,069 0,043 0,041

0,143 0,044 0,058

0,220 0,206 0,230

3,475 2,577 2,405

0,223 0,247 0,240

0,232 0,236 0,231

0,048 0,042 0,041

0,121 0,085 0,093

0,132 0,111 0,174

0,122 0,052 0,063

0,061 0,044 0,054

0,073 0,035 0,048

0,089 0,046 0,046

0,047 0,043 0,044

0,041 0,039 0,044

0,083 0,046 0,038

0,168 0,074 0,097

0,247 0,118 0,099

0,248 0,251 0,242

0,243 0,259 0,250

0,054 0,048 0,055

0,048 0,040 0,037

0,058 0,045 0,046

0,053 0,045 0,049

0,069 0,058 0,065

0,912 0,344 0,379

0,089 0,037 0,042

December 2009

PCR AmpliSense

adenovirus adenovirus adenovirus adenovirus negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative negative

IDEIA Rotavirus DakoCytomation OPCrit = 0.150

0,040 0,044 0,039 0,041 0,260 0,044 0,046 0,042 0,047 0,041 0,039 0,048 0,055 0,035 0,039 0,040 0,041 0,033 0,046 0,049 0,048 0,038 0,039 0,029 0,037 0,036 0,043 0,043 0,039 0,042 0,034 0,037 0,041 0,036

Rotavirus - antigen - ELISA-BEST JSC "Vector-Best"

OPCrit O P Crit OPCrit

0,250 0,263 0,251

0,105 0,042 0,043

0,046 0,143 0,133

0,227 0,045 0,042

0,065 0,068 0,054

0,125 0,039 0,042

0,196 0,191 0,182

0,209 0,170 0,154

0,316 0,071 0,073

0,058 0,043 0,049