QUALITY CONTROL PANELS OF SERA
PERFORMANCE PANELS FOR THE TESTING DIAGNOSTIC TEST KITS
(RUSSIAN STANDARDS OF QUALITY CONTROL SERA)
Performance Panels are panels of human sera intended for use in control serological assays. Each Performance Panel consists of a thoroughly characterized series of serum collected from different individuals. The sera members of Performance Panels represent the full reactivity range of the assay, including negative reactivity. Each panel also contains a comprehensive datasheet with testing results from a variety of commercially available test kits. Performance Panels are used to challenge test kits performance, sensitivity, and specificity. Performance Panels can be used to evaluate and validate new test methods, new equipment, demonstrate lab proficiency, and train laboratory personnel. As the performance panels represent the Russian collection of sera containing markers of infectious diseases and containing no such markers, they can be helpful for international users during for the test kits characteristics investigation.
These panels are developed and manufactured under the requirements specification the Tarasevich State Institute of Standardization and Control of Medical Biological Preparations. Each taken separately performance panel of sera is recognized by the National Immunobiological Standard and has specific branch standard number.
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| CAT# | PRODUCT | APPLICATION | DESCRIPTION | PACK SIZE |
| INS-20 (R) |
Standard AB(-)HIV |
Specificity evaluation of test kits for detection of anti-HIV antibodies | Human sera containing no anti-HIV antibodies and p24 antigen of HIV-2 | 20 x 400 ul* |
| IBS-16-1 (R) |
Standard AB(+)HIV-1 |
Sensitivity evaluation of test kits for detection of anti-HIV-1 antibodies | Human sera containing anti-HIV-1 antibodies | 16 x 400 ul* |
| IBS-8-2 (R) |
Standard AB(+)HIV-2 |
Sensitivity evaluation of test kits for detection of anti-HIV-2 antibodies | Human sera containing anti-HIV-2 antibodies | 8 x 400 ul* |
| IPS-10-1 (R) | Standard AG (+) HIV-1 p24 | Specificity and sensitivity evaluation of test kits for detection of p24 antigen of HIV | Human sera containing p24 antigen of HIV-1 | 10 x 400 ul* |
| CBS-24 (R) | Standard AB (+/-) HCV | Specificity and sensitivity evaluation of test kits for detection of anti-HCV antibodies | Human sera containing anti-HCV antibodies | 16 x 250 ul* |
| Human sera containing no anti-HCV antibodies | 8 x 250 ul* | |||
| CBP-20 | P-AB (+/-) HCV | Specificity and sensitivity evaluation of test kits for anti- HCV antibodies detection. Sera contain anti-HCV antibodies to different HCV subtypes. | Human sera containing anti-HCV antibodies | 16 x 300 ul* |
| Human sera containing no anti-HCV antibodies | 4 x 300 ul* | |||
| BSР-24 | P-AG (+/-) HBs | Specificity and sensitivity evaluation of test kits for HBsAg detection. Sera contain different HBsAg subtypes. | Human sera containing HBsAg | 20 x 300 ul* |
| Human sera containing no HBsAg | 4 x 300 ul* | |||
| XGS-36 (R) | Standard AB-G (+/-) C. trachomatis | Specificity and sensitivity evaluation of test kits for detection of IgG antibodies to Chlamydia trachomatis | Human sera containing species-specific IgG to Chlamydia trachomatis | 16 x 400 ul* |
| Human sera containing no species-specific IgG to Chlamydia trachomatis | 20 x 400 ul* | |||
| XAS-30 | Standard AB-A (+/-) C. trachomatis | Specificity and sensitivity evaluation of test kits for detection of IgA antibodies to Chlamydia trachomatis | Human sera containing species-specific IgA to Chlamydia trachomatis | 12 x 400 ul* |
| Human sera containing no species-specific IgA to Chlamydia trachomatis | 18 x 400 ul* | |||
| VGS-36 (R) |
Standard AB-G (+/-) CMV |
Specificity and sensitivity evaluation of test kits for detection of IgG antibodies to cytomegalovirus | Human sera containing cytomegalovirus IgG | 20 x 200 ul* |
| Human sera containing no cytomegalovirus IgG | 16 x 200 ul* | |||
| SGS-36 (R) | Standard AB-G (+/-) HSV | Specificity and sensitivity evaluation of test kits for detection of IgG antibodies to Herpes simplex virus-1,2 | Human sera containing Herpes simplex virus-1,2 IgG | 20 x 200 ul* |
| Human sera containing no Herpes simplex virus-1,2 IgG | 16 x 200 ul* | |||
| LBP-24 | P-AB T.Pallidum | Specificity and sensitivity evaluation of test kits for detection of antibodies to Treponema pallidum | Human sera containing anti-Treponema pallidum antibodies | 16 x 200 ul* |
| Human sera containing no anti-Treponema pallidum antibodies | 8 x 200 ul* |
(R) - After CAT# means that this product has registration as Standard panel in Russia.
* - 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 Qualification Panels
