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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. The HIV-panels are supplied for incoming control of test kits within the frame of National Project “Zdorovie” (Health), Russia. 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 were developed under the requirements specification the Tarasevich State Institute of Standardization and Control of Medical Biological Preparations. Each taken separately performance panel of sera was recognized as 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*
BBS-16 Standard AB(+/-)HBcoreAg Specificity and sensitivity evaluation of test kits for HBcore Ag detection. Human sera containing total anti-HBcoreAg 8 x 500 ul*
Human sera containing no total anti-HBcoreAg 8 x 500 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 IgG antibodies to Chlamydia trachomatis 16 x 400 ul*
Human sera containing no IgG antibodies to Chlamydia trachomatis 20 x 400 ul*
XAS-30 (R) Standard AB-A(+/-)C.trachomatis Specificity and sensitivity evaluation of test kits for detection of IgA antibodies to Chlamydia trachomatis Human sera containing IgA antibodies to Chlamydia trachomatis 12 x 400 ul*
Human sera containing no IgA antibodies 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 IgG antibodies to cytomegalovirus
20 x 200 ul*
Human sera containing no antibodies to cytomegalovirus
16 x 200 ul*
SGS-36 (R) Standard AB-G(+/-)HSV-1,2 Specificity and sensitivity evaluation of test kits for detection of IgG antibodies to Herpes simplex virus-1,2 Human sera containing antibodies to Herpes simplex virus-1,2
20 x 200 ul*
Human sera containing no antibodies to Herpes simplex virus-1,2
16 x 200 ul*
LBS-24 Standard 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*
TGS-24 Standard AB-G(+/-)T.gondii Specificity and sensitivity evaluation of test kits for detection of IgG antibodies to Toxoplasma gondii Human sera containing IgG antibodies to Toxoplasma gondii 16 x 200 ul*
Human sera containing no IgG antibodies to Toxoplasma gondii 8 x 200 ul*

 

(R) - After CAT# means that this product has registration as standard panel (OCO) 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 Control & Qualification Panels, Control sera

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