Diagnostic drug. Contains antibodies. Represents the blood serum of animals immunized with a killed Salmonella culture. Designed for serological identification of bacteria of the genus Salmonella in the agglutination reaction on glass. monoreceptor serum agglutinating salmonella (O) Group affiliation
Diagnostician. At, cat. obtained in 3 stages: in the 1st step, we select salmonella (for example, S. typhimurium with Ar structure O-1,4,5,12; Mi 1,2) and heat it in a water bath to destroy the flagella H-Ar, rest. Only O-Ar 1,4,5,12. At the second stage, rabbits are hyperimmunized with the remaining O-Ag of salmonella, O-1,4,5,12 At are formed in the rabbit. This is a polyvalent serum. At the 3rd stage, we perform serum depletion according to Castellani. To do this, whey is obtained by adding pre-heated water. Bath from the same ser.group for example S.hudelberg o-45.12 Ar, there will be a connection between Ar and the remaining O-1 At. The resulting serum is used for seroidentification of Salmonella in RA at stage 3 bact. analysis.
48Agglutinating adsorbed Salmonella O-serum receptor 9.
Diagnostic drug. Contains antibodies. Represents the blood serum of animals immunized with a killed Salmonella culture. Obtained using the Castellani method. Designed for serological identification of bacteria of the genus Salmonella in the agglutination reaction on glass.
50. Agglutinating adsorbed polyvalent Salmonella O-serum (groups A, B, C, D, E).
Diagnostic drug. Contains antibodies to O-antigen. Represents the blood serum of animals immunized with a killed Salmonella culture. Obtained using the Castellani method. Designed for serological identification of bacteria of the genus Salmonella in the agglutination reaction on glass.
51 Agglutinating adsorbed Salmonella H-serum receptor d
Diagnostic drug. Contains antibodies to the H-antigen receptor d. Represents the blood serum of rabbits immunized with a killed Salmonella culture. Obtained using the Castellani method. Designed for serological identification of bacteria of the genus Salmonella in the agglutination reaction on glass.
50. Agglutinating adsorbed polyvalent serum against Shigella flexneri I-V.
Diagnostic drug. Contains antibodies. They are sera from rabbits immunized with formalinized live suspensions of Shigella, which are typical in all respects. When interacting with appropriate microorganisms, serum causes their agglutination. Designed for serological identification of Shigella flexneri I-V. Diagnostic Shigella sera are lyophilized adsorbed rabbit sera containing monoreceptor antibodies to 38 antigens. Polyvalent sera are produced for eight groups of antigens. The preparations are intended for the identification of bacteria of the genus Shigella in an agglutination reaction. Diagnostic Shigella sera have an antibody titer in the agglutination reaction of at least 1:40. Using these sera, you can identify any bacteria of the genus Shigella according to the international classification. The drug is bottled in ampoules of 2 ml. Released in dry form. The shelf life of monoreceptor dry serums is 5 years, polyvalent dry serums are 3 years when stored in a dry, dark place at a temperature of 4-80 C.
Salmonella polyvalent serum ABCDE
I N S T R U C T I O N
on the use of a set of reagents
"Salmonella diagnostic sera
adsorbed O-polyvalent
for the agglutination reaction"
Registration certificate No. RZN 2017/5914 from 06 .07 .2017 G.
PURPOSE
The set of reagents “Diagnostic Salmonella sera adsorbed O-polyvalent for the agglutination reaction” is intended for identification using the agglutination reaction (RA) on a glass slide of bacteria of the genus Salmonella isolated from human biological material (urine, feces, gastric lavages, vomit).
More than 2,400 pathogenic Salmonella serovars have been described that cause acute gastroenteritis, typhus-like and septicopyemic forms of the disease, collectively called salmonellosis. The main causative agents of salmonellosis are Salmonella serovars enteritidis, typhi murium, cholerae-suis, haifa, etc.
The set of reagents “Salmonella diagnostic sera adsorbed O-polyvalent for agglutination reaction” is intended for the identification of such bacteria for the purpose of prescribing proper treatment sick.
The set is available in 4 configuration options:
Set No. 1 Salmonella polyvalent O-serum of the main groups (A, B, C,D, E):
Set No. 1/1 - Salmonella polyvalent O-serum of the main groups, dry;
Set No. 1/2 - Salmonella polyvalent O-serum of the main groups, liquid;
Set No. 2 Salmonella polyvalent O-serum rare groups:
Set No. 2/1 - Salmonella polyvalent O-serum of rare groups, dry;
Set No. 2/2 - Salmonella polyvalent O-serum of rare groups, liquid.
Each configuration option is available in 2 versions.
COMPOSITION AND EQUIPMENT OF THE SET
| Version 1 | Version 2 | |||
| Set No. 1 Salmonella polyvalent O-serum of main groups (A, B, C, D, E) | ||||
| Set No. 1/1 | dry immune adsorbed rabbit or sheep blood serum containing O-agglutinins against antigens 1;2;3,4;5;6.1;6.2;7;8;9;10;12,Vi; inactivated; amorphous mass of white or cream color | 5 fl. (2.0 ml each) | 1 fl. (2.0 ml each) | |
| Set No. 1/2 | liquid immune adsorbed rabbit or sheep blood serum containing O-agglutinins against antigens 1;2;3,4;5;6.1;6.2;7;8;9;10;12,Vi; inactivated; colorless or pinkish-yellow liquid | 5 fl. (2.0 ml each) | 1 fl. (2.0 ml each) | |
| Set No. 2 Salmonella polyvalent O-serum of rare groups | ||||
|
Set No. 2/1 |
dry immune adsorbed rabbit or sheep blood serum of the following groups (F; G; H, I, J, K, L, M, N, O, P, Q, R, S, T, U, W, V, X,Y , Z,52,53,54′ 55,57, 58, 59, 60, 61), containing O-agglutinins against antigens 11;13, 22; 14, 24; 23; 24; 25; 16; 17; 18; 21;28; 30; 35; 38; 39; 40; 41; 42; 43; 44; 45; 47; 48; 50; 52; 53; 54; 55; 57; 58; 59; 60; 61); inactivated; amorphous mass of white or cream color | 5 fl. (2.0 ml each) | 1 fl. (2.0 ml each) | |
| Set No. 2/2 | liquid immune adsorbed rabbit or sheep blood serum of the following groups (F; G; H, I, J, K, L, M, N, O, P, Q, R, S, T, U, W, V, X,Y , Z,52,53,54′ 55,57, 58, 59, 60, 61), containing O-agglutinins against antigens 11;13, 22; 14, 24; 23; 24; 25; 16; 17; 18; 21;28; 30; 35; 38; 39; 40; 41; 42; 43; 44; 45; 47; 48; 50; 52; 53; 54; 55; 57; 58; 59; 60; 61); inactivated; colorless or pinkish-yellow liquid | 5 fl. (2.0 ml each) | 1 fl. (2.0 ml each) | |
The components of the kit are packaged in a box, the box contains instructions for use and an abbreviated diagram of the antigenic structure of bacteria of the Salmonella group .
KEY CONSUMER CHARACTERISTICS
The basic versions of the kits are designed to study 200 (version 1) or 40 samples (version 2).
OPERATING PRINCIPLE
Adsorbed sera contain antibodies that agglutinate Salmonella cultures containing homologous O-antigens, and do not agglutinate Salmonella cultures containing heterologous O-antigens.
SAMPLES STUDYED
The culture isolated during bacteriological research from biological material (urine, feces, gastric lavage, vomit) and grown in test tubes on nutrient agar slants for 18-20 hours at a temperature of 37 0 C.
It is allowed to store the isolated culture on nutrient agar at a temperature of +2 - +8 for 2 days.
Collection, storage and preparation of human biological material must be carried out in accordance with GOST R 53079.4-2008 “Quality assurance of clinical laboratory research", MU 4.2.2723-10 " Laboratory diagnostics salmonellosis, detection of salmonella in food products and environmental objects."
ANALYTICAL AND DIAGNOSTIC CHARACTERISTICS
Specific activity:
Analytical sensitivity: determined with homologous museum test strains of Salmonella and is 100%
Analytical Specificity : determined with heterologous museum test strains of Salmonella and is 100%
The reproducibility of the results is 100%.
Diagnostic sensitivity (95% confidence level) was:
Diagnostic specificity (95% confidence level) was:
Museum test strains of Salmonella - 98.07%-100%;
Salmonella cultures isolated from clinical material of patients - 98.25%-100%.
PRECAUTIONS
The kit is biologically safe, but test specimens must be handled as potentially infectious material.
Precautions when working with the kit - compliance with the rules "Instructions for measures to prevent the spread of infectious diseases when working in clinical diagnostic laboratories of medical institutions" (Approved by the USSR Ministry of Health on January 17, 1991), GOST R 52905–2007 (ISO 15190:2003).
The set of reagents, in accordance with SanPiN 2.1.7.2790-10 “Sanitary and epidemiological requirements for the management of medical waste,” belongs to class B (epidemiologically hazardous waste).
Disposal or destruction, disinfection of reagent kits should be carried out in accordance with SanPiN 2.1.7.2790-10 “Sanitary and epidemiological requirements for the management of medical waste” and MU 287-113 “ Guidelines on disinfection, pre-sterilization cleaning and sterilization of medical devices.”
METHOD OF APPLICATION
Equipment and materials (for “manual” staging)
Stopwatch;
Refrigerating chamber with a temperature range of 2-8 0 C;
Semi-automatic pipettes with operating ranges: 5-50 µl, 20-200 µl;
Disposable tips for the indicated pipettes;
Containers for liquid and solid waste;
Rubber or latex gloves, disinfectants;
Bacteriological loop;
Slide glasses;
Magnifier with magnification (2x);
0.9% solution sodium chloride;
Dry air thermostat maintaining temperature (37 ± 1) °C;
70% solution of ethyl alcohol and 6% solution of hydrogen peroxide (disinfectant solutions) or solutions of other disinfectants approved for use by SP 1.32322-08.
METHOD OF APPLICATION
Setting up RA on glass
Salmonella polyvalent O-serum
Dry whey is dissolved in 2 ml of 0.9% aqueous solution sodium chloride
One drop (about 50 µl) of serum and one drop of 0.9% aqueous sodium chloride solution are applied to a glass slide. The identified culture, grown in test tubes on slanted nutrient agar for 18-20 hours at a temperature of 37 o C, is removed from the top of the agar with a loop, applied to a glass slide near a drop of 0.9% aqueous solution of sodium chloride and emulsified (control for the absence of spontaneous agglutination). In the absence of spontaneous agglutination, the manipulation is repeated in a drop of O serum, forming a uniform opaque suspension. The results are taken into account for 1-2 minutes, gently shaking the glass. A homogeneous suspension indicates a negative result.
In the presence of agglutinins to the test strain, a flocculent agglutinate appears in a drop of serum within 1-2 minutes.
The result of RA is recorded visually using a magnifying glass with magnification (2x) according to the quadruple system
The results of RA are taken into account and evaluated as follows:
++++ – clear agglutinate with complete clearing of the liquid in the drop (100%).
+++ – distinct aggutinate against the background of a turbid liquid (75%)
++ – slight agglutinate against the background of turbid liquid (50%)
+ – traces of agglutinate, the liquid in the drop is cloudy (25%)
(–) – negative result, homogeneously cloudy liquid in the drop (0%).
RA with diagnostic serum is taken into account only if the spontaneous agglutination control result is negative.
The culture under study is assigned to the corresponding O-group if RA with polyvalent serum of this group is obtained on glass not lower than (+++).
BEST BEFORE DATE
Set No. 1/1, No. 1/2. Salmonella polyvalent O-serum, dry - 3 years from the date of acceptance by the manufacturer's OPF.
Salmonella diagnostic sera PETSAL O-type
PETSAL® polyvalent O-serum, adsorbed for the agglutination reaction (RA), obtained from the blood of rabbits, containing O-antibodies to antigens of the main groups of Salmonella
Serological identification of Salmonella spp. according to the Kauffman-White scheme in the agglutination reaction on glass without further dilution.
Polyvalent sera of the main groups (A, B, C, D, E) contain O-antibodies against antigens 1; 2; 3; 4; 5; 61; 62; 7; 8; 9; 10; 12; Vi. The titer of specific antibodies is not lower than 1:40.
Adsorbed sera contain antibodies that agglutinate Salmonella cultures containing homologous O- and H-antigens, and do not agglutinate Salmonella cultures containing heterologous O- and H-antigens. The reaction results are recorded using the four-cross system for 1-2 minutes
Serums, 2 ml, lyophilized.
Homogeneous cream-colored powder, hygroscopic.
Packaging in ampoules with a capacity of 5 ml, hermetically sealed. Packaging and labeling in accordance with TU 9389-008-01895016-07, 5 or 10 ampoules of one name in a pack or cardboard box. Each box contains instructions for use, an abbreviated diagram of the antigenic structure of bacteria of the genus Salmonella, and an ampoule knife.
The drug is stored in a dry, dark room at a temperature from +4 to 10°C.
Shelf life - 3 years from the production date indicated on the packaging.
Registered in the FS SZ.
The preparations are intended for the serological identification of bacteria of the genus Salmonella in the glass agglutination reaction. The preparations are immune adsorbed rabbit sera containing agglutinins to the O-antigens and H-antigens of Salmonella. The drugs are produced in the form of monovalent and polyvalent O- and H-sera.
Polyvalent sera of the main groups (A, B, C, D, E) contain O-antibodies against antigens 1; 2; 3; 4; 5; 6 1 ; 6 2 ; 7; 8; 9; 10; 12; Vi; rare groups (F, G, H, J, I, K, L, M, N, O, P, Q, R, S, T, U, W, X, Y, Z, 52, 53, 54, 55 , 57, 58, 59, 60, 61) contain O-antibodies against antigens: 11; 13, 22; 14, 24; 16; 17; 18; 21; 23; 24; 25; 28; 30; 35; 38; 39; 40; 41; 42; 43; 44; 45; 47; 48; 50; 52; 53; 54; 55; 57; 58; 59; 60; 61.
Polyvalent H-sera contain H-antibodies against related antigenic complexes: gm, gp, gq, gpu, fg, fgs, gst, gt, mt, gmt, gms; Z4 4 Z 24 ; Z4 4 Z 32 ; I-1,2; 1.5; 1.6; 1.7.
The titer of specific antibodies in O- and H-sera and polyvalent H sera is not lower than 1:80, and in polyvalent O sera – 1:40.
The set of reagents “Diagnostic Salmonella sera adsorbed O-polyvalent for the agglutination reaction” is intended for identification using the agglutination reaction (RA) on a glass slide of bacteria of the genus Salmonella isolated from human biological material (urine, feces, gastric lavages, vomit).
More than 2,400 pathogenic Salmonella serovars have been described, causing acute gastroenteritis, typhoid-like and septicopyemic forms of the disease in humans, collectively called salmonellosis. The main causative agents of salmonellosis are Salmonella serovars enteritidis, typhi murium, cholerae-suis, haifa, etc.
The set of reagents “Salmonella diagnostic sera adsorbed O-polyvalent for agglutination reaction” is intended for the identification of such bacteria in order to prescribe the correct treatment for the patient.
The set is available in 4 configuration options:
Set No. 1 Salmonella polyvalent O-serum of the main groups (A, B, C, D, E):
Set No. 1/1 - Salmonella polyvalent O-serum of the main groups, dry;
Set No. 1/2 - Salmonella polyvalent O-serum of the main groups, liquid;
Set No. 2 Salmonella polyvalent O-serum of rare groups:
Set No. 2/1 - Salmonella polyvalent O-serum of rare groups, dry;
Set No. 2/2 - Salmonella polyvalent O-serum of rare groups, liquid.
Each configuration option is available in 2 versions.
COMPOSITION AND EQUIPMENT OF THE SET
|
Version 1 |
Version 2 |
|||
|
Set No. 1 Salmonella polyvalent O-serum of main groups (A, B, C, D, E) |
||||
|
Set No. 1/1 |
dry immune adsorbed rabbit or sheep blood serum containing O-agglutinins against antigens 1;2;3,4;5;6.1;6.2;7;8;9;10;12,Vi; inactivated; amorphous mass of white or cream color |
5 fl. (2.0 ml each) |
1 fl. (2.0 ml each) |
|
|
Set No. 1/2 |
liquid immune adsorbed rabbit or sheep blood serum containing O-agglutinins against antigens 1;2;3,4;5;6.1;6.2;7;8;9;10;12,Vi; inactivated; colorless or pinkish-yellow liquid |
5 fl. (2.0 ml each) |
1 fl. (2.0 ml each) |
|
|
Set No. 2 Salmonella polyvalent O-serum of rare groups |
||||
|
Set No. 2/1 |
dry immune adsorbed rabbit or sheep blood serum of the following groups (F; G; H, I, J, K, L, M, N, O, P, Q, R, S, T, U, W, V, X,Y , Z,52,53,54" 55,57, 58, 59, 60, 61), containing O-agglutinins against antigens 11; 13, 22; 14, 24; 23; 24; 25; 16; 17; 18; 21; 35; 41; ; amorphous mass of white or cream color |
5 fl. (2.0 ml each) |
1 fl. (2.0 ml each) |
|
|
Set No. 2/2 |
liquid immune adsorbed rabbit or sheep blood serum of the following groups (F; G; H, I, J, K, L, M, N, O, P, Q, R, S, T, U, W, V, X,Y , Z,52,53,54" 55,57, 58, 59, 60, 61), containing O-agglutinins against antigens 11; 13, 22; 14, 24; 23; 24; 25; 16; 17; 18; 21; 35; 41; ; colorless or pinkish-yellow liquid |
5 fl. (2.0 ml each) |
1 fl. (2.0 ml each) |
|
The components of the kit are packaged in a box, the box contains instructions for use and an abbreviated diagram of the antigenic structure of bacteria of the Salmonella group .
KEY CONSUMER CHARACTERISTICS
The basic versions of the kits are designed to study 200 (version 1) or 40 samples (version 2).
OPERATING PRINCIPLE
Adsorbed sera contain antibodies that agglutinate Salmonella cultures containing homologous O-antigens, and do not agglutinate Salmonella cultures containing heterologous O-antigens.
SAMPLES STUDYED
A culture isolated during bacteriological studies from biological material (urine, feces, gastric lavage, vomit) and grown in test tubes on slanted nutrient agar for 18-20 hours at a temperature of 37 0 C is being studied.
It is allowed to store the isolated culture on nutrient agar at a temperature of +2 - +8 for 2 days.
The collection, storage and preparation of human biological material must be carried out in accordance with GOST R 53079.4-2008 “Quality assurance of clinical laboratory research”, MU 4.2.2723-10 “Laboratory diagnosis of salmonellosis, detection of salmonella in food products and environmental objects”.
ANALYTICAL AND DIAGNOSTIC CHARACTERISTICS
Specific activity:
Analytical sensitivity: determined with homologous museum test strains of Salmonella and is 100%
Analytical Specificity : determined with heterologous museum test strains of Salmonella and is 100%
The reproducibility of the results is 100%.
Diagnostic sensitivity (95% confidence level) was:
Diagnostic specificity (95% confidence level) was:
Museum test strains of Salmonella - 98.07%-100%;
Salmonella cultures isolated from clinical material of patients - 98.25%-100%.
PRECAUTIONS
The kit is biologically safe, but test specimens must be handled as potentially infectious material.
Precautionary measures when working with the kit - compliance with the rules "Instructions for measures to prevent the spread of infectious diseases when working in clinical diagnostic laboratories of medical institutions" (Approved by the USSR Ministry of Health on January 17, 1991), GOST R 52905-2007 (ISO 15190: 2003).
The set of reagents, in accordance with SanPiN 2.1.7.2790-10 “Sanitary and epidemiological requirements for the management of medical waste,” belongs to class B (epidemiologically hazardous waste).
Disposal or destruction, disinfection of reagent kits should be carried out in accordance with SanPiN 2.1.7.2790-10 "Sanitary and epidemiological requirements for the management of medical waste" and MU 287-113 "Guidelines for disinfection, pre-sterilization cleaning and sterilization of medical products."
METHOD OF APPLICATION
Equipment and materials (for “manual” staging)
Stopwatch;
Refrigerating chamber with a temperature range of 2-8 0 C;
Semi-automatic pipettes with operating ranges: 5-50 µl, 20-200 µl;
Disposable tips for the indicated pipettes;
Containers for liquid and solid waste;
Rubber or latex gloves, disinfectants;
Bacteriological loop;
Slide glasses;
Magnifier with magnification (2x);
0.9% sodium chloride solution;
Dry air thermostat maintaining temperature (37 ± 1) °C;
70% solution of ethyl alcohol and 6% solution of hydrogen peroxide (disinfectant solutions) or solutions of other disinfectants approved for use by SP 1.32322-08.
METHOD OF APPLICATION
Setting up RA on glass
Salmonella polyvalent O-serum
Dry whey is dissolved in 2 ml of 0.9% aqueous sodium chloride solution
One drop (about 50 µl) of serum and one drop of 0.9% aqueous sodium chloride solution are applied to a glass slide. The identified culture, grown in test tubes on slanted nutrient agar for 18-20 hours at a temperature of 37 o C, is removed from the top of the agar with a loop, applied to a glass slide near a drop of 0.9% aqueous solution of sodium chloride and emulsified (control for the absence of spontaneous agglutination). In the absence of spontaneous agglutination, the manipulation is repeated in a drop of O - serum, forming a uniform opaque suspension. The results are taken into account for 1-2 minutes, gently shaking the glass. A homogeneous suspension indicates a negative result.
In the presence of agglutinins to the test strain, a flocculent agglutinate appears in a drop of serum within 1-2 minutes.
The result of RA is recorded visually using a magnifying glass with magnification (2x) according to the quadruple system
The results of RA are taken into account and evaluated as follows:
Clear agglutinate when the liquid in the drop is completely clear (100%).
Clear aggutinate against a background of turbid liquid (75%)
Slight agglutinate against a background of turbid liquid (50%)
Traces of agglutinate, the liquid in the drop is cloudy (25%)
(-) - negative result, homogeneously cloudy liquid in the drop (0%).
RA with diagnostic serum is taken into account only if the spontaneous agglutination control result is negative.
The culture under study is assigned to the corresponding O-group if RA with polyvalent serum of this group is obtained on glass not lower than (+++).
BEST BEFORE DATE
Set No. 1/1, No. 1/2. Salmonella polyvalent O-serum, dry - 3 years from the date of acceptance by the manufacturer's OPF.
Set No. 2/1, No. 2/2. Salmonella polyvalent O-serum, liquid - 1 year from the date of acceptance by the OPF manufacturer.
STORAGE AND TRANSPORTATION
Storage
In the manufacturer's packaging at a temperature from 2 o C to 8 o C. Freezing is not allowed.
After opening the packages, unused reagents can be stored in tightly closed packages at a temperature of 2 to 8 o C for 1 month.
Transportation
At temperatures from 2 to 8 o With transport of all types in covered vehicles in accordance with the transportation rules in force for this type of transport. Freezing is not allowed. Transportation is allowed at temperatures from 9 o C to 25 o C for 14 days.
VACATION CONDITIONS
For healthcare institutions.
