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PERFORMANCE PANELS FOR THE TESTING DIAGNOSTIC TEST KITS
(RUSSIAN NATIONAL 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 of Russian National Control and Research Agency – Tarasevich State Institute of Standardization and Control of Medical Biological Preparations. Each taken separately performance panel of sera is recognized by the Russian National Immunobiological Standard and has specific branch standard number.

CAT#	PRODUCT	APPLICATION	DESCRIPTION	PACK SIZE
A-010(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*
A-011(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*
A-013(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*
A-014(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*
A-030(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*
A-030(R)	Standard AB (+/-) HCV		Human sera containing no anti-HCV antibodies	8 x 250 ul*
A-060(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*
A-060(R)	Standard AB-G (+/-) C. trachomatis		Human sera containing no species-specific IgG to Chlamydia trachomatis	20 x 400 ul*
A-063(R)	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*
A-063(R)	Standard AB-A (+/-) C. trachomatis		Human sera containing no species-specific IgA to Chlamydia trachomatis	18 x 400 ul*
A-080(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*
A-080(R)	Standard AB-G (+/-) CMV		Human sera containing no cytomegalovirus IgG	16 x 200 ul*
A-091	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*
A-091	Standard AB T.Pallidum		Human sera containing no anti-Treponema pallidum antibodies	8 x 200 ul*
A-093	Standard AB-G T. pallidum	Specificity and sensitivity evaluation of test kits for detection of IgG antibodies to p17 and p41(TmpA) antigens of Treponema pallidum	Human sera containing IgG antibodies to p17 and p41(TmpA) antigens of Treponema pallidum	12 x 200 ul*
A-093	Standard AB-G T. pallidum		Human sera containing no IgG antibodies to p17 and p41(TmpA) antigens of Treponema pallidum	6 x 200 ul*
A-020(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*
A-020(R)	Standard AB-G (+/-) HSV		Human sera containing no Herpes simplex virus-1,2 IgG	16 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.