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 System of External Quality Assessment of Federal Service of Surveillance in Healthcare and Social Development (Roszdravnadzor), Russia and local EQA programs.
Each Control Panel contains 4 or 5 positive members and 2-4 negative members. 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 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.
| CAT# | PRODUCT | APPLICATION | PACK SIZE |
| IPC-8 | Control AG/AB HIV-1,2 | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HIV infection | 6 x 500 ul* |
| 2 x 500 ul* | |||
| IBC-8 | Control AB HIV-1,2 | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HIV infection | 6 x 400 ul* |
| 2 x 400 ul* | |||
| IBI-24-1 | 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 | 24 x 400 ul* |
| IPI-24 | External run control AG HIV-1 p24 | Day-to-day testing the performance of ELISA test kits for HIV-1 p24 antigen detection inside clinical laboratory | 24 x 400 ul* |
| IBQ-5-1 | Qualification AB HIV-1 | Testing the work standards of clinical diagnostic laboratories and qualification of personnel dealing with serodiagnostics of HIV infection | 4 x 400 ul* |
| 1 x 400 ul* | |||
| CBC-8 | Control AB HCV | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HCV infection | 4 x 500 ul* |
| 4 x 500 ul* | |||
| CBQ-5 | Qualification AB HCV | Testing the work standards of clinical diagnostic laboratories and qualification of personnel dealing with serodiagnostics of HCV infection | 4 x 250 ul* |
| 1 x 250 ul* | |||
| CBI-24 | External run control AB HCV | Day-to-day testing the performance of ELISA test kits for anti-HCV antibodies detection inside clinical laboratory | 24 x250 ul* |
| BSC-8 | 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* | |||
| BTC-8 | Control AB HBsAg | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection | 5 x 500 ul* |
| 3 x 500 ul* | |||
| BBC-8 | Control AB HBcoreAg | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection | 4 x 500 ul* |
| 4 x 500 ul* | |||
| BMC-8 | Control AB-M HBcoreAg | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection | 4 x 500 ul* |
| 4 x 500 ul* | |||
| BFC-8 | Control AB HBeAg | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection | 4 x 500 ul* |
| 4 x 500 ul* | |||
| BEC-8 | Control HBeAg | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HBV infection | 4 x 500 ul* |
| 4 x 500 ul* | |||
| BSQ-5 |
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* | |||
| BSI-24 |
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 | 24 x 800 ul* |
| VGC-8 | Control AB-G CMV | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of CMV infection | 5 x 500 ul* |
| 3 x 500 ul* | |||
| SGC-8 | Control AB-G HSV | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of HSV infection | 5 x 500 ul* |
| 3 x 500 ul* | |||
| TGC-8 | Control AB-G T.gondii | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of toxoplasmosis | 5 x 500 ul* |
| 3 x 500 ul* | |||
| XGC-8 | Control AB-G C. trachomatis | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of chlamydiosis | 4 x 500 ul* |
| 4 x 500 ul* | |||
| XAC-8 | Control AB-A C. trachomatis | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of chlamydiosis | 4 x 500 ul* |
| 4 x 500 ul* | |||
| LBC-6 | 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* | |||
| LBQ-5 | Qualification AB T.pallidum | Testing the work standards of clinical diagnostic laboratories and qualification of personnel dealing with serodiagnostics of syphilis | 4 x 200 ul* |
| 1 x 200 ul* | |||
| LBI-24 | 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 | 24 x 200 ul* |
| MGC-8 | Control AB-G M.hominis | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of mycoplasmosis | 4 x 500 ul* |
| 4 x 500 ul* | |||
| UGC-8 | Control AB-G U.urealyticum | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of ureaplasmosis | 4 x 500 ul* |
| 4 x 500 ul* | |||
| GGC-8 | Control AB-G G.vaginalis | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of gardnerelosis | 4 x 500 ul* |
| 4 x 500 ul* | |||
| AGC-8 | Control AB-G C.albicans | Testing the work standards of clinical diagnostic laboratories dealing with serodiagnostics of cadidiasis | 4 x 500 ul* |
| 4 x 500 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.
See also Performance Panels
