Qualification & Linearity Panels

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Qualification Panels

SeraCare Qualification Panels are intended for use as part of ongoing programs for reagent lot acceptance and internal assay proficiency testing.

Qualification Panels may also be used for training and qualifying technical personnel in the performance of diagnostic tests.

Features

Anti-CMV Qualification Panel Cat No QTC711

This is a panel manufactured from human serum or plasma. Package of six members with a range of concentrations of anti-CMV. Five panel members were formulated with various reactivities for anti-CMV, and one nonreactive member was formulated from anti-CMV negative pools. 1 vial per member. For research use only.
Fill size 3.0 mL per vial More

Anti-HBc Qualification Panel Cat No QHG711

This is a panel manufactured from human serum or plasma. Package of six members that have a range of concentrations of anti-HBc. Five panel members were formulated with various reactivities for anti-HBc, and one nonreactive member was formulated from an anti-HBc negative pool. 1 vial per member. For research use only.
Fill size 2.0 mL per vial More

Anti-HCV Qualification Panel Level 1 Cat No QHV711

This is a panel manufactured from human serum or plasma. Package of six members with a range of concentrations of anti-HCV. Five panel members were formulated with various reactivities for anti-HCV, and one nonreactive member was formulated from anti-HCV negative pools. 1 vial per member. For research use only.
Fill size 1.0 mL per vial More

Anti-HCV Qualification Panel Level 2 Cat No QHV712

This is a panel manufactured from human serum or plasma. Package of six members with a range of reactivity in anti-HCV assays. Five panel members were formulated with various reactivities for anti-HCV, and one nonreactive member was formulated from anti-HCV nonreactive pools. 1 vial per member. For research use only.
Fill size 1.0 mL per vial More

Anti-HIV-1/2 Qualification Panel Cat No QRZ761

This is a panel manufactured from human serum or plasma. Package of six members with a range of reactivity for anti-HIV 1 and anti-HIV 2 EIA assays. Four panel members were formulated with various reactivities for anti-HIV 1, one member was formulated with reactivity for anti-HIV 2, and one nonreactive member was formulated from anti-HIV 1/2 negative pools. 1 vial per member. For research use only.
Fill size 1.0 mL per vial More

Anti-HTLV I/II Qualification Panel Cat No QRP712

This is a panel manufactured from human serum or plasma. Package of six members with a range of reactivity in anti-HTLV I and anti-HTLV II assays. Three panel members were formulated with various reactivities for anti-HTLV I, two panel members were formulated with various reactivities for anti-HTLV II, and one nonreactive member was formulated from anti-HTLV I/II negative pools. 1 vial per member. For research use only.
Fill size 1.5 mL per vial More

HIV-1 RNA / HCV RNA / HBV DNA Qualification Panel
Cat No QCA702

This is a panel manufactured from human serum or plasma. Package of five members with a range of reactivity in HIV-1 RNA, HCV RNA and HBV DNA assays. Three panel members are reactive for either HIV-1 RNA, HCV RNA or HBV DNA individually and one member is formulated to be reactive for HIV-1, RNA, HCV RNA and HBV DNA in combination. One panel member is nonreactive for HIV-1 RNA, HCV RNA, and HBV DNA. For research use only.
Fill size 4 mL per vial More

HBsAg Qualification Panel Cat No QHA711

This is a panel manufactured from human serum or plasma. Package of six members with a range of concentrations of HBsAg. The five reactive members represent dilutions of HBsAg subtype ad and HBsAg subtype ay stocks in nonreactive pools. The one nonreactive member represents a different HBsAg nonreactive pool. 1 vial per member. For research use only.
Fill size 2.0 mL per vial More

HIV 1/2/O/p24 Qualification Panel Cat No QRX701

The HIV 1/2/O/p24 Qualification Panel QRX701 is a panel of six members with established reactivity in anti-HIV-1, anti-HIV-2, anti-HIV-1 group O, HIV p24 antigen and combination assays. This panel may be used for training, qualifying, and re-qualifying technical personnel in the performance of tests for the detection of antibodies to HIV-1, HIV-2 and HIV-1 group O, and HIV p24 antigen. The panel may also be used as part of ongoing programs of lot acceptance and internal proficiency testing for these assays, to isolate system errors and in troubleshooting, as a component of a quality assurance program. For Research Use Only. Not for use in diagnostic procedures.
Fill size 3.5 mL per vial More

HPV Genotype Qualification Panel Cat No QSH701

This panel consists of 4 members, 3 positive and 1 negative for HPV, manufactured from cultured human cells containing full length HPV episomal DNA. The positive members consist of transfected cells containing HPV16, HPV18, and HPV51 mixed with non-infected cells and preserved in a buffered methanol solution. The negative member consists of non-infected cells preserved in a buffered methanol solution. For Research Use Only. Not for use in diagnostic procedures.
Fill size 4.0 mL per vial More

Syphilis Qualification Panel Cat No QSS701

This is a panel manufactured from human serum or plasma. Package of six members. Five panel members were formulated with various reactivities for Syphilis, and one nonreactive member was formulated from Syphilis nonreactive pools. 1 vial per member. For research use only.
Fill size 2.0 mL per vial More

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Performance Panels for Other Infectious Diseases

Performance Panels are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for evaluation and validation of test methods, method comparison, and documentation of laboratory proficiency.

Features

Anti-EBV Mixed Titer
Performance Panel
Cat No PME201

This is a panel of undiluted serum and plasma samples collected from multiple donors, and demonstrating a variety of antibody reactivities. Package of 25 members, 21 members with infectious mononucleosis heterophile antibody and/or EBV specific reactivity, selected to demonstrate IgG and/or IgM reactivity. One negative serum and three negative plasmas are included as nonreactive controls. 1 vial per member. For research use only.
Fill size 0.5 mL per vial   More

Anti-EBV Mixed Titer
Performance Panel
Cat No PME202

This is a panel of undiluted aliquots from plasma units with reactivity ranging from negative to strongly positive for anti-EBV markers. The anti-EBV Mixed Titer Performance is intended for use by diagnostic manufacturers and clinical laboratories to evaluate their Epstein-Barr Virus (EBV) test systems using well characterized specimens, and to provide comprehensive data for comparative analysis. For Research Use Only. Not for use in diagnostic procedures.
Fill size 1.2 mL per vial   More

Anti-Herpes Mixed Titer
Performance Panel
Cat No PTH202

This is a panel of naturally occurring plasma and serum specimens ranging from negative to strongly positive for anti-HSV 1/2 IgG and IgM markers. PTH202 is intended for use by diagnostic manufacturers and clinical laboratories and researchers to develop, evaluate or troubleshoot their anti-HSV 1/2, anti-HSV-1, and anti-HSV 2 tests methods using well characterized specimens, and to provide comprehensive data for comparative analysis. 21 members 1 member per vial. For Research Use Only. Not for use in diagnostic procedures..
Fill size 1.2 mL per vial   More

Anti-Trypanosoma cruzi (Chagas)
Performance Panel
Cat No PMT204-1.2

This is a panel of naturally occurring plasma specimens with reactivity ranging from negative to strongly positive for anti-T.cruzi. Specimens are undiluted aliquots from plasma units collected from blood donors in the United States, Central and South America and Mexico. Package of 21 members. For Research Use Only. Not for use in diagnostic procedures.
Fill size 1.2 mL per vial  More

Anti-HTLV I/II Mixed Titer
Performance Panel
Cat No PRP208-1.2

This is a panel of undiluted plasma samples collected from multiple donors. Package of 21 members, 10 members are confirmed positive for anti-HTLV I, 10 members are confirmed positive for anti-HTLV II, and one member is non-reactive. For research use only.
Fill size 1.2 mL per vial  More

Lyme Mixed Titer Performance Panel
Cat No PTL202

This is a panel of undiluted serum and plasma samples collected from multiple donors, and demonstrating a variety of antibody reactivities. Package of 15 members, 14 members with anti-Borrelia burgdorferi (Lyme Disease) reactivity and one member negative for Lyme Disease, included as a nonreactive control. 1 vial per member. For research use only.
Fill size 0.5 mL per vial   More

Syphilis Mixed Titer
Performance Panel (Modified)
Cat No PSS202(M)

The Syphilis Mixed Titer Performance Panel PSS202(M) is a panel of naturally occuring plasma specimens. This panel is intended for use by diagnostic manufacturers and clinical laboratories to evaluate their Syphilis test systems using well characterized specimens, and to provide comprehensive data for comparative analysis. For research use only. Not for use in diagnostic procedures.
Fill size 0.5 mL per vial   More

Anti-Dengue Mixed Titer Performance Panel
Cat No PVD201-1.2

Anti-Dengue Mixed Titer Performance Panel is a panel of undiluted, unpreserved plasma specimens from different individuals displaying a range of reactivities for Anti-Dengue IgM and IgG antibodies. 1 vial per member. For Research Use Only. Not for use in diagnostic procedures.
Fill size 1.2 mL per vial   More

Parvovirus B19 Mixed Titer Performance Panel
Cat No PVP201-1.2

This is a panel of naturally occurring plasma specimens consisting of 21 members positive for Parvovirus B19 DNA, IgM and/or IgG antibodies. 1 vial per member. For Research Use Only. Not for use in diagnostic procedures.
Fill size 1.2 mL per vial   More

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Performance Panels and ACCUTYPE™ Viral Isolates

SeraCare Performance Panels are assembled from highly characterized, disease state patient samples and rigorously tested. Our panels can be used with most instrument platforms and test methods.

ACCUTYPE H1N1

Hepatitis

ACCUTYPE HIV-1 Viral Particle Isolates

HIV

ACCUTYPE HIV-1 LAV 8E5 Virus Subtype B
ToRCH

ACCUTYPE Purified HIV-1 RNA
Other Infectious Diseases

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ACCUTYPE™ HIV-1 Viral Particle Isolates

ACCUTYPE HIV Viral Particle Isolates are an extensive collection of pedigreed, globally-relevant, HIV-1 subtypes from the Major (M) and Outlier (O) groups. For research use only.

Features


Origin in Djibouti HIV-1 genotype AG Fill size 1.0 mL More	Cat No 500447	Origin in Indonesia HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500474

Origin in Djibouti HIV-1 genotype AG Fill size 1.0 mL More	Cat No 500449	Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500475

Origin in Uganda HIV-1 genotype A Fill size 1.0 mL More	Cat No 500450	Origin in Indonesia HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500476

Origin in Liberia HIV-1 genotype AG Fill size 1.0 mL More	Cat No 500451	Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500477

Origin in Ghana HIV-1 genotype A Fill size 1.0 mL More	Cat No 500452	Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500478

Origin in Thailand HIV-1 genotype B Fill size 1.0 mL More	Cat No 500453	Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500479

Origin in the USA HIV-1 genotype B Fill size 1.0 mL More	Cat No 500454	Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500480

Origin in Brazil HIV-1 genotype B Fill size 1.0 mL More	Cat No 500455	Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500481

Origin in the USA HIV-1 genotype B Fill size 1.0 mL More	Cat No 500457	Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500482

Origin in the USA HIV-1 genotype B Fill size 1.0 mL More	Cat No 500460	Origin in Brazil HIV-1 genotype F Fill size 1.0 mL More	Cat No 500483

Origin in the USA HIV-1 genotype B Fill size 1.0 mL More	Cat No 500461	Origin in Brazil HIV-1 genotype F Fill size 1.0 mL More	Cat No 500484

Origin in the USA HIV-1 genotype B Fill size 1.0 mL More	Cat No 500462	Origin in Romania HIV-1 genotype F Fill size 1.0 mL More	Cat No 500486

Origin in Ethiopia HIV-1 genotype C Fill size 1.0 mL More	Cat No 500463	Origin in Romania HIV-1 genotype F Fill size 1.0 mL More	Cat No 500487

Origin in Senegal HIV-1 genotype C Fill size 1.0 mL More	Cat No 500464	Origin in Zaire HIV-1 genotype G Fill size 1.0 mL More	Cat No 500488

Origin in Somalia HIV-1 genotype C Fill size 1.0 mL More	Cat No 500465	Origin in Kenya HIV-1 genotype G Fill size 1.0 mL More	Cat No 500489

Origin in Djibouti HIV-1 genotype C Fill size 1.0 mL More	Cat No 500466	Origin in Zaire HIV-1 genotype H Fill size 1.0 mL More	Cat No 500490

Origin in Uganda HIV-1 genotype C Fill size 1.0 mL More	Cat No 500467	Origin in Cameroon HIV-1 genotype Group O Fill size 1.0 mL More	Cat No 500491

Origin in Zambia HIV-1 genotype C Fill size 1.0 mL More	Cat No 500468	Origin in Cameroon HIV-1 genotype Group O Fill size 1.0 mL More	Cat No 500492

Origin unknown HIV-1 genotype C Fill size 1.0 mL More	Cat No 500469	Origin in the USA HIV-1 genotype Group O Fill size 1.0 mL More	Cat No 500493

Origin in Senegal HIV-1 genotype D Fill size 1.0 mL More	Cat No 500470	Origin in Spain HIV-1 genotype Group O Fill size 1.0 mL More	Cat No 500494

Origin in Uganda HIV-1 genotype D Fill size 1.0 mL More	Cat No 500471	Origin in Kyrgyzstan HIV-1 genotype A Fill size 1.0 mL More	Cat No 502193

Origin in Uganda HIV-1 genotype D Fill size 1.0 mL More	Cat No 500472	Origin in Germany HIV-1 genotype D Fill size 1.0 mL More	Cat No 502194

Origin in Thailand HIV-1 genotype E Fill size 1.0 mL More	Cat No 500473	Origin in Germany HIV-1 genotype D Fill size 1.0 mL More	Cat No 502195

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ACCUTYPE™ HIV-1 LAV 8E5 Virus Subtype B

ACCUTYPE HIV-1 LAV 8E5 Virus Subtype B is derived from a cloned cell line containing a full length HIV genome in which a deletion mutation in the HIV RT gene renders the HIV RT negative and non-infectious.

Features


ACCUTYPE HIV-1 LAV 8E5 Virus Subtype B	Cat No HIV8E5
This product is a reverse transcriptase (RT) mutant tissue culture supernatant of the 8E5/LAV cell line, a HAT-sensitive OEM derivative of A3.01 cells which contain a single integrated copy of proviral DNA coding for defective HIV-1 particle. For research use only. Fill sizes 1.0 mL More 10 mL More

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Performance Panels for Hepatitis

Performance Panels for Hepatitis are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for evaluation and validation of test methods, method comparison, and documentation of laboratory proficiency.

Features

Anti-Hepatitis A Virus (HAV) Mixed Titer Performance Panel
Cat No PHT202-1.2

This is a panel of naturally occurring plasma specimens consisting of a set of 21 aliquots from plasma units with reactivities ranging from negative to strongly positive for Hepatitis A IgG and/or IgM antibody. One specimen negative for Hepatitis A IgG and IgM antibody is included as a nonreactive sample. 1 vial per member. For Research Use Only. Not for use in diagnostic procedures. Fill size 21 members, 1.2 mL per vial More

Anti-HBc IgM Mixed Titer
Performance Panel
Cat No PHE203

This is a panel of undiluted plasma samples collected from multiple donors. Package of 25 members with reactivities ranging from negative to strongly positive for anti-HBc IgM. 1 vial per member. For research use only.
Fill size 1.0 ml per vial   More

Anti-HBc/HBs Mixed Titer
Performance Panel
Cat No PHG203(M2)

This is a panel of undiluted plasma samples collected from multiple donors consisting of 12 members that are anti-HBc or anti-HBc and anti-HBs reactivity. Panel members 2, 3 and 15 from PHG203 are no longer available. 1 vial per member. For research use only.
Fill size 1 vial per member, 12 members, 1.5 mL per vial   More

Anti-HCV Mixed Titer
Performance Panel
Cat No PHV207

This is a panel of undiluted plasma samples collected from multiple donors. Package of 25 members, 23 members with anti-HCV reactivities ranging from weak to strong positive and two members negative for anti-HCV. 1 vial per member. For research use only.
Fill size 1.0 mL per vial   More

HBsAg Low Titer Performance Panel
Cat No PHA107

This is a panel of undiluted plasma samples collected from multiple donors. Package of 21 members, 20 members with HBsAg reactivity near the sensitivity limit and 1 member negative for HBsAg, included as nonreactive control. 1 vial per member. For research use only.
Fill size 1.5 mL per vial More

HBsAg Mixed Titer Performance Panel
Cat No PHA207

This is a panel of undiluted plasma samples collected from multiple donors. Package of 21 members, 20 members with HBsAg reactivity ranging from weak to strong positive and 1 member negative for HBsAg, included as nonreactive control. 1 vial per member. For research use only.
Fill size 1.50 mL per vial More

HCV Low Titer Performance Panel
Cat No PHV106(M)

This is a panel of undiluted plasma samples collected from multiple donors. Package of 14 members, 13 members with moderately positive anti-HCV reactivity and one member negative for anti-HCV, included as a nonreactive control. 1 vial per member. For research use only.
Fill size 1.0 mL per vial   More

HCV RNA Genotype Performance Panel
Cat No PHW204

This is a panel of 10 members representing 9 distinct HCV genotypes from diverse world origins. The 9 positive members were formulated by diluting individual HCV positive plasma samples into HCV RNA negative plasma pools. Test results were generated using commercially available HCV RNA and HCV genotype assays. 1 member per vial. For Research Use Only. Not for use in
diagnostic procedures.
Fill size 1.2 mL per vial   More

Worldwide HBV DNA Performance Panel
Cat No WWHD301

The Worldwide HBV DNA Performance Panel WWHD301 is a panel of naturally occurring plasma specimens from diverse geographic locations. This panels consists of 20 members that are positive for HBV DNA including specimens characterized as HBV genotypes A, A/E, A/F, B, C, D, D/F, D/G, E, F, G, and H. For Research Use Only. Not for use in diagnostic procedures. Fill size 1.2 mL per vial   More

Worldwide HCV RNA Performance Panel
Cat No WWHD303

This is a panel of 20 undiluted aliquots from plasma units. All 20 members are positive for HCV RNA. Panel members include specimens characterized as HCV genotypes 1 through 6, and their subtypes. For research use only.
Fill size 1.2 mL per vial   More

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Performance Panels for ToRCH

Performance Panels for ToRCH are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for evaluation and validation of test methods, method comparison, and documentation of laboratory proficiency.

Features

Anti-CMV Mixed Titer Performance Panel
Cat No PTC203-1.2

This is a panel of naturally occurring plasma specimens reactive for cytomegalovirus (CMV) IgM and IgG consisting of 21 members. 20 members are positive for anti-cytomegalovirus, IgM and/or IgG antibodies, and one member is negative for all CMV markers. 1 vial per member. For Research Use Only. Not for use in diagnostic procedures. Fill size 1.2 mL per vial More

Anti-Rubella Mixed Titer Performance Panel
Cat No PTR201

This is a panel of undiluted serum and plasma samples collected from multiple donors, and demonstrating a variety of antibody reactivities. Package of 25 members, 23 members with anti-Rubella reactivity, selected to demonstrate IgG and/or IgM reactivity. One negative serum and one negative plasma are included as nonreactive controls. 1 vial per member. For research use only.
Fill size 0.5 mL per vial More

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Performance Panels for HIV

Performance Panels for HIV are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for evaluation and validation of test methods, method comparison, and documentation of laboratory proficiency.

Features


Anti-HIV-1 Low Titer Performance Panel	Cat No PRB108(M)
This is a panel of undiluted plasma samples collected from multiple donors. Package of 10 members, 9 members with anti-HIV-1 reactivity near the sensitivity limit and one member negative for anti-HIV-1, included as a nonreactive control. 1 vial per member. For research use only. Fill size 1.0 mL per vial More

Anti-HIV-1 Low Titer Performance Panel	Cat No PRB109
This is a panel of undiluted plasma samples collected from multiple donors. Package of 20 members, 19 members with anti-HIV-1 reactivity near the sensitivity limit and one member negative for anti-HIV-1, included as a nonreactive control. 1 vial per member. For research use only. Fill size 1.0 mL per vial More

Anti-HIV-1 Mixed Titer Performance Panel	Cat No PRB205
This is a panel of undiluted plasma samples collected from multiple donors. Package of 24 members, 22 members are positive for anti-HIV-1 at different levels, and two specimens negative for anti-HIV-1 are included as nonreactive controls. 1 vial per member. For research use only. Fill size 1.0 mL per vial More

Anti-HIV-1/2 Performance Panel	Cat No PRZ208
This is a panel of undiluted plasma samples collected from multiple donors. Package of 15 members, 7 members with anti-HIV-1 reactivity, 7 members with anti-HIV-2 reactivity, and 1 member negative for anti-HIV included as a nonreactive control. 1 vial per member. For research use only. Fill size 0.25 mL per vial More

Anti-HIV-2 Performance Panel	Cat No PRF203
This is a panel of undiluted plasma samples collected from multiple donors. Package of 11 members with reactivity ranging from negative to highly positive HIV-2 reactivity. One specimen negative for anti-HIV-2 is included as a nonreactive sample. 1 vial per member. For research use only. Fill size 1.0 mL per vial More

HIV P24 Antigen Mixed Titer Performance Panel	Cat No PRA204
This is a panel of undiluted plasma samples collected from multiple donors. Package of 25 members with reactivity ranging from weak to strong positive for HIV p24 antigen by commercially available assays. 1 vial per member. For research use only. Fill size 1.5 mL per vial More

HIV P24 Antigen Mixed Titer Performance Panel	Cat No PRA204(B)
This is a panel of undiluted plasma samples collected from multiple donors. Package of 12 members designed for use by manufacturers and laboratories to evaluate the sensitivity and specificity of HIV antigen and HIV antigen/antibody combination tests using well characterized specimens, and to provide data for comparative analysis. 1 vial per member. For research use only. Fill size 1.5 mL per vial More

HIV RNA Genotype Performance Panel	Cat No PRD202
This is a panel of cultured HIV virus samples representing nine distinct HIV subtypes, A through H. Package of 10 members, 9 members formulated by diluting cultured HIV-1 virus into HIV RNA negative defibrinated human plasma. One negative member manufactured from HIV RNA negative defibrinated plasma is included as a nonreactive control. 1 vial per member. For research use only. Fill size 1.1 mL per vial More

HIV-1 Genotype Performance Panel	Cat No PRD201
This is a panel of cultured HIV virus samples from multiple HIV-1 genotypes. Package of nine members, eight positive and one negative for HIV-1 RNA. The positive panel members represent HIV genotypes AG, B, C, D, AE, F, G, and H. 1 vial per member. For research use only. Fill size 1.2 mL per vial More

HIV-1 Incidence/Prevalence Performance Panel	Cat No PRB601
This is a panel of undiluted plasma samples of HIV-1 collected from multiple donors. Package of 15 members includes 7 members characterized as incident (new infection) and 8 members characterized as prevalent (long-standing infection). 1 vial per member. For research use only. Fill size 1.0 mL per vial More

Teragenix HIV Drug Resistance Performance Panel	Cat No PRD250
SeraCare Life Sciences acquired the Teragenix T-20 Drug Resistance Panel (HIVDRP-002a) in 2008. This is a panel of naturally occurring plasma specimens from HIV infected individuals demonstrating multiple reverse transcriptase and protease associated mutations. Package of 10 members, reactive for HIV RNA. 1 vial per member. For research use only. Fill size 1.0 mL per vial More

Worldwide HIV Performance Panel	Cat No WWRB304
This is a panel of undiluted plasma samples collected from multiple donors from diverse geographical locations. Package of 20 members, 19 members with reactivities for HIV-1 Group M Subtypes A, B, C, D, F, G, H, J, CRF01_AE, CRF02_AG, and HIV-2. One member is a nonreactive control. 1 vial per member. For research use only. Fill size 0.5 mL per vial More

Worldwide HIV Performance Panel	Cat No WWRB305
This is a panel of undiluted 0.5 mL plasma samples from different individuals positive for thirteen HIV subtypes, including several rare circulating recombinant forms and mixed subtypes. Represented in this panel are subtypes A, B, C, CRFO1_AE, CRF02_AG, CRF03_AB, D, G, K, H/A1, K/CRF09, G/CRF02, and CRF01/CRF15, collected from nine countries in Europe, Africa, Central and South America, and Central and Southeast Asia. Panel members were tested for HIV-1 RNA, HIV p24 antigen, and antiHIV-1 and -1/2, using a variety of commercially available test methods, including rapid and confirmatory tests and 4th generation screening tests for Ag/Ab. Subtypes were determined using commercially available HIV RNA sequencing methods. For Research Use Only. Not for use in diagnostic procedures. Fill size 0.5 mL per vial More

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Sensitivity Panels

SeraCare Sensitivity Panels are designed for use by therapeutic and diagnostic manufacturers and clinical laboratories, to challenge test systems.

Features


HBsAg Sensitivity Panel	Cat No PHA808(M)
This is a panel manufactured from HBsAg subtypes ad and ay pools, diluted in pooled serum that tested negative for HBsAg, anti-HBs, anti-HIV 1/2, anti-HCV. Package of two dilution series containing nineteen members with varying concentrations of HBsAg subtypes ad and ay (9 aliquots of subtype ad and 10 aliquots of subtype ay), and a negative control. 1 vial per member. For research use only. Fill size 1.5 mL per vial More

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ACCUTYPE™ Purified HIV-1 RNA

ACCUTYPE Purified HIV-1 RNA is derived from globally-relevant HIV subtypes A-H and group O. Certificate of Analysis includes RNA quantified in c/mL (copies/mL). For research use only.

Features


Origin in Ghana HIV-1 genotype A Fill size 1.0 mL More	Cat No 500404	Origin in Brazil HIV-1 genotype F Fill size 1.0 mL More	Cat No 500437

Origin in Liberia HIV-1 genotype AG Fill size 1.0 mL More	Cat No 500403	Origin in Kenya HIV-1 genotype G Fill size 1.0 mL More	Cat No 500441

Origin in Thailand HIV-1 genotype B Fill size 1.0 mL More	Cat No 500405	Origin in Zaire HIV-1 genotype H Fill size 1.0 mL More	Cat No 500442

Origin in Djibouti HIV-1 genotype C Fill size 1.0 mL More	Cat No 500418	Origin in Cameroon HIV-1 genotype Group O Fill size 1.0 mL More	Cat No 500443

Origin in Uganda HIV-1 genotype D Fill size 1.0 mL More	Cat No 500423	Origin in Cameroon HIV-1 genotype Group O Fill size 1.0 mL More	Cat No 500444

Origin in Thailand HIV-1 genotype AE Fill size 1.0 mL More	Cat No 500431	Origin in Spain HIV-1 genotype Group O Fill size 1.0 mL More	Cat No 500446

Origin in Brazil HIV-1 genotype F Fill size 1.0 mL More	Cat No 500436

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Seroconversion Panels for HIV

Seroconversion Panels for HIV are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for benchmarking assays, validation of test methods, and regulatory or scientific submissions.

These are panels of undiluted plasma samples collected from a single donor during development of infection and subsequent immune response. For research use only.

Features

Evaluating HIV Antibody Test Sensitivity

Chart Key

= converts negative to positive	= converts positive to negative	= variable conversion	= all members positive

= all members negative	=members negative or indeterminate	= no data available

Catalog Number	Fill Size	Days Spanned	Days Between Members	HIV RNA	HIV Ag (p24)	Anti- HIV-1

PRB914	5 x 1.0 mL	31	3 to 18

PRB933	3 x 1.0 mL	27	6 to 21

PRB943	7 x 1.0 mL	21	2 to 5

PRB945	6 x 1.0 mL	20	2 to 5

PRB946	4 x 1.0 mL	11	3 to 4

PRB947	4 x 1.2 mL	20

PRB948	4 x 1.0 mL	23	3 to 18

PRB949(M)	4 x 1.0 mL	20	2 to 6

PRB950	4 x 1.0 mL	28	3 to 18

PRB951	6 x 1.0 mL	19	2 to 6

PRB955	5 x 1.0 mL	14	2 to 4

PRB956	5 x 1.0 mL	50	3 to 40

PRB958	6 x 1.0 mL	17	2 to 6

PRB961	9 x 1.0 mL	29	2 to 7

PRB962	6 x 1.0 mL	17	2 to 5

PRB963	7 x 1.0 mL	21	2 to 5

PRB964	6 x 1.0 mL	22	2 to 7

PRB965	6 x 1.0 mL	21	2 to 7

PRB966	10 x 1.0 mL	51	2 to 18

PRB967	6 x 1.0 mL	24	2 to 10

PRB968	10 x 1.0 mL	22	2 to 7

PRB969	10 x 1.0 mL	77	2 to 29

PRB970	4 x 1.0 mL	14	3 to 7

PRB971	4 x 1.0 mL	11	1 to 5

PRB972	6 x 1.0 mL	21	3 to 8

PRB973	4 x 1.2 mL	11	2 to 6

PRB974	4 x 1.2 mL	16	2 to 7

PRB975	5 x 1.2 mL	14	2 to 5

PRB976	4 x 1.2 mL	9	2 to 5

PRB977	4 x 1.2 mL	15	2 to 9

PRB978	7 x 1.2 mL	33	2 to 17

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Seroconversion Panels for Hepatitis B (HBV)

Seroconversion Panels for Hepatitis B are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for benchmarking assays, validation of test methods, and regulatory or scientific submissions.

These are panels of undiluted plasma samples collected from a single donor during development of infection and subsequent immune response. For research use only.

Features

Chart Key

= converts negative to positive	= converts positive to negative	= variable conversion	= all members positive

= all members negative	=members negative or indeterminate	= no data available


Catalog Number	Fill Size	Days Spanned	Days Between Members	HBV DNA	HBs Ag	HBe Ag	Anti- HBc IgM	Anti- HBc Total	Anti- HBe	Anti- HBs	Sub- type

PHM906	5 x 1.5 mL	157	3 to 137								ad

PHM912	9 x 1.5 mL	47	2 to 18								ad

PHM918	3 x 1.5 mL	12	5 to 7								ad

PHM921	6 x 1.5 mL	19	2 to 5								ad

PHM924	5 x 1.5 mL	43	6 to 23								ad

PHM926	8 x 1.5 mL	27	2 to 7			ND	ND	ND	ND	ND	IND

PHM929	9 x 1.5 mL	29	3 to 4			ND	ND	ND	ND	ND	ad

PHM934(M)	5 x 1.5 mL	84	3 to 70						ND	ND	ad

PHM936	8 x 1.5 mL	26	2 to 5						ND	ND	ad

PHM937	5 x 1.5 mL	16	2 to 7				ND	ND

PHM938	6 x 1.5 mL	16	2 to 5				ND	ND

PHM939	5 x 1.5 mL	21	3 to 8				ND	ND

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Seroconversion Panels for Hepatitis C (HCV)

Seroconversion Panels for Hepatitis C are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for benchmarking assays, validation of test methods, and regulatory or scientific submissions.

These are panels of undiluted plasma samples collected from a single donor during development of infection and subsequent immune response. For research use only.

Features

Chart Key

= converts negative to positive	= converts positive to negative	= variable conversion	= all members positive

= all members negative	=members negative or indeterminate	= no data available


Catalog Number	Fill Size	Days Spanned	Days Between Members	HCV RNA	Anti- HCV EIA	Anti- HCV RIBA	Geno- type

PHV911 (M)	4 x 1.0 mL	24	3 to 7				1a

PHV912	3 x 1.0 mL	7	3 to 4				2b/3

PHV913	4 x 1.0 mL	9	2 to 5				2b

PHV914	9 x 1.0 mL	33	3 to 5				2b

PHV915	4 x 1.0 mL	14	2 to 5				2b

PHV917 (M)	9 x 1.0 mL	152	2 to 46				2b

PHV918 (M)	7 x 1.0 mL	27	2 to 8				1a

PHV919	7 x 1.0 mL	35	3 to 7				1a

PHV920 (M)	9 x 1.0 mL	35	2 to 6				1a

PHV921	11 x 1.0 mL	43	3 to 8				3a

PHV922	6 x 1.2 mL	17	3 to 4				3a

PHV923	6 x 1.2 mL	23	2 to 10				1a

PHV924	6 x 1.2 mL	88	3 to 52				2a

PHV925	5 x 1.2 mL	27	2 to 17				1a

PHV926	5 x 1.2 mL	14	2 to 5				3a

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Seroconversion Panels for Other Viruses

Seroconversion Panels are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for benchmarking assays, validation of test methods, and regulatory or scientific submissions.

These are panels of undiluted plasma samples collected from a single donor during development of infection and subsequent immune response. For research use only.

Features

Chart Key

= converts negative to positive	= converts positive to negative	= variable conversion	= all members positive

= all members negative	=members negative or indeterminate	= no data available


Hepatitis A Seroconversion Panel

Catalog Number	Fill Size	Days Spanned	Days Between Members	HAV RNA	Anti- HAV Total	Anti- HAV IgM

PHT903	10 x 1.0 mL	180	3 to 35


West Nile Seroconversion Panel

Catalog Number	Fill Size	Days Spanned	Days Between Members	WNV RNA	Anti- WNV Total	Anti- WNV IgM

PWN901	5 x 1.5 mL	14	2 to 5

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Performance Panels for HPV

Performance Panels for HPV are intended for use by therapeutic and diagnostic manufacturers and clinical laboratories for evaluation and validation of test methods, method comparison, and documentation of laboratory proficiency.

Features


HPV Genotype Performance Panel	Cat No PSH301
This panel is provided to enable researchers, diagnostic manufacturers, and clinical labs to evaluate their HPV test systems using well-characterized samples. It is a panel of cultured human cells containing full-length, episomal DNA, representing high and low risk HPV types. Package of 5 members contains four positive members with transfected cells containing HPV16, HPV18, HPV31, or HPV11. The negative member contains non-infected cells. Cells are suspended in a buffered methanol solution. Supplied in single use vials, no additional processing required. 1 vial per member. For research use only. This panel is compatible with the most widely-used HPV test platforms, including Qiagen, Hologic, and Roche. Fill size 5 x 4.0 mL More

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Performance Panels for Hepatitis

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ACCUTYPE H1N1

ACCUTYPE H1N1 Viral Research Reagent is a multi-analyte transcribed RNA containing sequences for Influenza A virus, Swine Influenza A viruses, Swine H1N1 Influenza, and RNase P.

Features


ACCUTYPE H1N1 Viral Research Reagent	Cat No 501932
This research reagent is formulated for use with test methods that detect influenza viruses. ACCUTYPE H1N1 Viral Research Reagent is a multi-analyte transcribed RNA containing sequences for Influenza A virus, Swine Influenza A viruses, Swine H1N1 Influenza, and RNase P. For research use only. Not for use in diagnostic procedures. Fill size 1 x 50 uL More

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Verification Panels

SeraCare Verification Panels are intended for use as part of ongoing programs for reagent lot acceptance and internal assay proficiency testing.

Features

Anti-HIV 1/2 Verification Panel Cat No VRZ603

This is a panel manufactured from human plasma. Package of five members with established reactivity in anti-HIV 1/2 rapid assays. Three members have various reactivities for anti-HIV-1, one member is reactive for anti-HIV-2, and one member non-reactive for anti-HIV 1/2. The non-reactive member is formulated from anti-HIV 1/2 negative pools. 1 vial per member. For Research Use Only.
Fill size 0.5 mL per vial More

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Linearity Panels

Linearity Panels are used to evaluate the dynamic range of quantitative nucleic acid detection assays, and are useful for monitoring recovery at defined intervals, identifying consistency over a linear range, verification at kit lot changes or whenever there are indications of assay deterioration.

Features


HBV DNA Linearity Panel	Cat No PHD802
This is a panel of of eight positive members representing serial log dilutions of HBV DNA positive plasma in negative diluent, and one negative member. For Research Use Only. Not for use in diagnostic procedures. Fill size 1.2 mL per vial More

HCV RNA Linearity Panel	Cat No PHW805
This is a panel of of eight positive members representing serial log dilutions of HCV RNA positive plasma in negative diluent, and one negative member. For Research Use Only. Not for use in diagnostic procedures. Fill size 1.2 mL per vial More

HIV-1 RNA Linearity Panel	Cat No PRD802
This is a panel of seven positive members, prepared by diluting a cultured HIV-1 type B 8E5 virus in HIV-1 RNA negative diluent. Package of eight members includes on negative member. 1 vial per member. For research use only. Fill size 3.5 mL per vial More

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Seroconversion Panels

SeraCare Seroconversion Panels are undiluted samples collected from a single donor during development of infection and subsequent immune response. They are rigorously tested and available for use with most instrument platforms and test methods.

HIV

Hepatitis C (HCV)

Hepatitis B (HBV)

Other Viruses

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Autoimmune Disease Analytes

Shown below is a representative sampling of available plasma characterized for autoimmune disease analytes.*

Additional disease states are available. Inventory evolves constantly. Please inquire if your requirement is not found below.

Features

Allergen Positive	Microsomal (TPO)	Smooth Muscle (AMSO)
anti-Cardiolipin (IgG, IgM, IgA)	Mitochondrial (AMA)	SSa, SSb
C-ANCA	Nuclear Ab (ANA)	ssDNA
Histone	Rheumatoid Arthritis (RA)	Systemic Lupus
Gliadin	RNP	Thyroglobulin
JO-1	Smith	Tissue Transglutaminase

* Analytes listed in the table are Ab+ unless otherwise noted

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Safety & Quality Profile

Request Form

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Other Disease States and Conditions

Shown below is a representative sampling of available plasma for other disease states and conditions.

Additional disease states are available. Inventory evolves constantly. Please inquire if your requirement is not found below.

Features

Cancer/Oncology
Breast, Cervical, Colon,
Kidney, Lung, Myeloma,
Ovarian (CA-125), Prostate

Coagulation Factor
Low Factor V, VII, VIII
IX, X, XI, XII

Diabetes

Hematology
Anemia
(Pernicious or Sickle Cell)

Immune/Serology
ASO, Allergy RAST score
HLA, IgA, IgD, IgG, IgM,
IgE (allergen specific and
total)

Inflammatory
Elevated CRPO
B2 glycoprotein, RF
Osteoarthritis (joint)

Ob Gyn
Pregnancy hCG (bulk)
Multiparous Females

Problematic Disease States
Interfering Substances
(Lipemic, Icteric, Hemolyzed)
False Negatives
False Positives
RA/RF
Influenza Samples

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Safety & Quality Profile

Request Form

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Specialty Biologics

SeraCare has a wide range of specialty biologic products available.

Difficult-to-locate materials are continuously sourced and inventoried in our state-of-the-art biobank. Bulk materials can be made available for manufacture into custom controls, panels, and calibrators.

Features

Cerebrospinal Fluid	Normal Human Serum and Plasma
Clinical Samples	Red Cells
Cord Blood	Urine
Human Buffy Coat	Whole Blood
Leukopaks

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Safety & Quality Profile

Request Form

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Infectious Disease Analytes

Shown below is a representative sampling of available infectious disease analytes.*

Additional disease states are available. Inventory evolves constantly. Please inquire if your requirement is not found below.

Features

Bordetella Pertussis	HBsAg (ad, ay)	Mononucleosis
Chagas (anti-T. cruzi )	HCV (Ab, Ag, RNA)	Mumps (IgG, IgM)
Chlamydia (IgA, IgG, IgM)	HIV-1 (p24 Ag, Ab)	Mycoplasma (IgG, IgM)
CMV (IgG, IgM)	HIV-1 RNA (group M, O, subtypes, DRM3)	Parvovirus
Dengue	HIV-2 (Ab, RNA)	Rubella (IgG, IgM)
EBV (VCA, EA, EBNA)	Human Papilloma Virus (HPV)	Rubeola (IgG, IgM)
H. pylori (IgA, IgG, IgM)	HTLV-I, HTLV-II, HTLV I/II	Syphilis (RPR and anti-Treponema)
HAV (Total, IgG, IgM)	HSV-1 (IgG, IgM), HSV-2 (IgG, IgM)	Toxoplasmosis (IgG, IgM)
HBc (Total, IgG, IgM)	Influenza A/B	VZV (IgM)
HBeAg, HBe	Lyme (IgG, IgM)	West Nile Virus (IgG, IgM)

* Analytes listed in the table are Ab+ unless otherwise noted

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Safety & Quality Profile

Request Form

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Complete BioCollections

When your research programs for in vitro medical devices, test kit controls or calibrators depend on reliable delivery and extensive inventory of infectious and non-infectious disease state materials,
SeraCare is the name to know...

Materials sourced, characterized and processed
to satisfy your specific requirements | Worldwide procurement and donor databases | One of the largest and most diverse collections of disease state materials


Product Groups

Infectious Disease Analytes

Autoimmune Disease Analytes

Other Disease States and Conditions

SeraCare Global Patient Sample (GPS) Program

Specialty Biologics

View Brochure	Request Form

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Custom Reference Materials

SeraCare Configures to your Specifications

When you require

•   large quantities
•   specialized packaging
•   custom product configuration

SeraCare will work with you to develop the best solution, and satisfy your needs.

Our facilities are ISO certified and comply with cGMP standards, and we have expertise in virology, serology, immunology, and molecular biology.

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Product Features & Benefits


	•	A wide range of high-quality, highly-characterized HIV Cultured Virus

	•	45 isolates from 17 countries, including Group M subtypes A-H and Group O

	•	Purified RNA available for selected isolates

	•	For use in research, drug candidate screening, assay development, and method validation

	•	Viral quantitation by electron microscopy, RNA quantitation by nucleic acid assays

	•	Verification of isolate identity by sequence analysis

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Product Features & Benefits


	•	Extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent, assay, and platform performance, sensitivity and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Enables your lab to evaluate, monitor, and troubleshoot test and staff performance

	•	Minimizes down time and accelerates verification of new test methods, reagent systems, and platforms

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Product Features & Benefits


	•	Extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent, assay, and platform performance, sensitivity and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Enables your lab to evaluate, monitor, and troubleshoot test and staff performance

	•	Available for most instrument platforms and test methods

	•	Minimizes down time and accelerates verification of new test methods and platforms

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Product Features & Benefits


	•	Extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent assay/platform performance, sensitivity, and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Enables your lab to evaluate, monitor, and troubleshoot test and staff performance

	•	Minimizes down time and accelerates validation and verification of new test methods, reagent systems, and platforms

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Product Features & Benefits


	•	Extensive array of panels helps your lab maintain the highest standards for assay validation, regulatory compliance, and method development

	•	Each panel includes comprehensive, comparative data from a variety of methods and commercially available test kits, allowing you to independently challenge reagent, assay, and platform performance, sensitivity and specificity

	•	Assembled from highly characterized, disease state patient samples, and developed specifically for infectious disease testing, both serology and NAT

	•	Enables your lab to evaluate, monitor, and troubleshoot test and staff performance

	•	Available for most instrument platforms and test methods

	•	Minimizes down time and accelerates verification of new test methods and platforms

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Product Features & Benefits


	•	Purified HIV-1 RNA is available for selected isolates of highly-characterized HIV Cultured Virus

	•	For use in research, drug candidate screening, assay development, and method validation

	•	Viral quantitation by electron microscopy, RNA quantitation by nucleic acid assays

	•	Verification of isolate identity by sequence analysis

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Product Features & Benefits


	•	High-quality, highly-characterized HIV cell culture supernatant

	•	Non-infectious Reverse Transcriptase (RT) mutant

	•	For use in research, drug candidate screening, assay development, method validation, and manufacture

	•	RNA quantitation by nucleic acid assays

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Product Features & Benefits


	Our disease state collection ranks among the largest and most diverse. Materials can be:

	•	Characterized in our ISO-certified labs to meet a wide variety of reactivity profiles

	•	Processed to meet your needs

	•	Sourced to your specifications

	•	Available from both individual donors and pools

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Safety & Quality Profile


•	All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards

•	Complete donor traceability and quality control
	—	Materials are fully documented

•	Detailed Certificates of Analysis provided

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Product Features & Benefits


	•	Transcribed RNA containing viral sequences for InfA, Universal Swine, Swine H1, and RNase P

	•	For use in research, assay development, and method validation

	•	All SeraCare facilities are ISO 9001 AND 13485 certified and comply with cGMP standards