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CONTROL AND QUALIFICATION PANELS OF SERA

CONTROL SERA - EXTERNAL RUN CONTROLS

 

Control Panels are panels of human sera intended for use in external control and testing the work standards of clinical diagnostic laboratories. Control Panels are used to demonstrate serological lab proficiency. Control Panels can also be used to challenge test kits performance, sensitivity, and specificity, to evaluate and validate new test methods, new equipment, show up the mistakes occurred during ELISA test kits performance, correct these mistakes, and train laboratory personnel.

Control Panels are included in the program of The Federal Service External Quality Assessment of Ministry of Health, Russian Federation and local EQA programs.

Each Control Panel contains 4 or 5 positive members and 2-4 negative members with the exception of «Control AB HIV-1». All sera are thoroughly characterized by a range of commercially available test kits.

Qualification panels have similar intended use to that of the Control panels. The sera included into the control panel are differentiated to positive and negative. The sera included into the qualification panel are also differentiated to positive and negative and additionally positive sera are ranged in the order of marker concentration increasing.

Each Qualification Panel contains 4 positive members, which represent serial dilutions of human serum and 1 negative member.

Control sera are intended for laboratory external run control and monitoring of ELISA test kits performance inside clinical laboratory.

Laboratory external run control set consists of 10 equal members representing the preparations lyophilized from inactivated human sera. Each external run control contains certain infectious disease marker, e.g. viral antigen, antibodies to viral antigen.

 

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CAT#

PRODUCT

APPLICATION

PACK SIZE

A-012

Control AB
HIV-1

Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HIV infection

8 x 400 ul*

A-015

External run control AB HIV-1

Day-to-day testing the performance of ELISA test kits for anti-HIV-1 antibodies detection inside clinical laboratory

10 x 400 ul*

A-031

Control AB HCV

Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HCV infection

4 x 250 ul*

4 x 250 ul*

A-033

Qualification AB HCV

Testing the work standards of clinical diagnostic laboratories and qualification of personnel dealing with serodiagnostics of HCV infection

4 x 800 ul*

1 x 800 ul*

A-034

External run control AB HCV

Day-to-day testing the performance of ELISA test kits for anti-HCV antibodies detection inside clinical laboratory

10 x 800 ul*

A-061

Control AB-G C.trachomatis

Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of chlamydiosis

4 x 400 ul*

4 x 400 ul*

A-065

Control AB-A C. trachomatis

Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of chlamydiosis

4 x 400 ul*

4 x 400 ul*

A-071

Control AG HBs

Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection

5 x 800 ul*

3 x 800 ul*

A-072

Control AB HBV

Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection

5 x 500 ul*

3 x 500 ul*

A-073

Qualification
AG HBs

Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection

4 x 800 ul*

1 x 800 ul*

A-074

External run control
Ag HBs

Day-to-day testing the performance of ELISA test kits for HBsAg detection inside clinical laboratory dealing with serodiagnostics of HBV infection

10 x 800 ul*

A-090

Control AB T.Pallidum

Testing the work standards of
clinical diagnostic laboratories dealing with serodiagnostics of syphilis

4 x 1000 ul*

2 x 1000 ul*

A-092

External run control AB T.Pallidum

Day-to-day testing the performance of ELISA test kits for anti-T. pallidum antibodies detection inside clinical laboratory

10 x 200 ul*

 

* The volumes of sera indicated in "ul"s mean volumes before lyophilization. Sera should be reconstituted back by adding water. Sera are supplied lyophilized and as powders.

 

All instruction manuals links to which are posted on this page in the table are for informative purposes only.  Please use only with the instruction manuals supplied with the test kit to perform a test.

 

See also Performance Panels





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