Blood Donor Screening

Blood Donor Screening Immuno and molecular reagents for developing blood bank screening assays

Blood transfusion is a life-saving intervention that has an essential role in patient management within health care systems. The establishment of systems to ensure that all donated blood is screened for transfusion-transmissible infections is a core component of every national blood program. Universal screening for HIV-1, HIV-2, Hepatitis B (HBV), Hepatitis C (HCV) and Syphilis are recommended as mandatory by the World Health Organization (WHO) for the provision of a safe blood supply. These infections can cause chronic disease with possible serious consequences and present the greatest infection risk to recipients of transfusion. Infections such as malaria, Chagas disease and the human T-cell lymphotropic viruses I/II (HTLV), Zika, West Nile and CMV can also pose a significant threat to the blood supply in some countries, especially where these diseases are endemic or there is high prevalence in the general population.

Recommended universal screening markers & assays * :

NAT or EIA/CLIA assay for HIV-1, 2 and Type O antibodies, can be used in combination with HIV-1 p24 antigen detection.

HIV-1 & HIV-2:

NAT or EIA/CLIA assay for hepatitis B surface antigen (HBsAg). Anti-hepatitis B core (HBcAg) assays can also be used as an additional marker in some countries with low HBV prevalence.

Hepatitis B:

EIA or CLIA assay for HCV antibodies (typically against the antigens NS3, NS4 NS5 and HCV core).

Hepatitis C:

Syphilis: (Treponema pallidum)

EIA assay for specific treponemal antibodies (typically p15, p17, p42.5, p47 or TmpA).

*Screening Donated Blood for Transfusion-Transmissible Infections: Recommendations. World Health Organization (WHO) Recommendations 2010.

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Universal Screening

HBV WHO Recommended: EIA or CLIA assay for Hepatitis B surface antigen (HBsAg). Anti-Hepatitis B core antigen (HBcAg) assays can also be used as an additional marker in some countries with low HBV prevalence. Recombinant Antigens VTI610 Hepatitis B Core Virus (HBcAg), P. pastoris Entire sequence of core protein (a.a.183) Antibodies C18286M MAb to HBsAg (ad/ay), pair C18212M MAb to HBsAg (ad/ay), pair C01247M MAb to HBsAg (ad/ay), pair C01248M MAb to HBsAg (ad/ay), pair B65811R Rabbit anti-HBsAg (ad/ay), pair HCV WHO Recommended: EIA or CLIA assay for HCV antibodies (typically against the antigens NS3, NS4 NS5 and HCV core). Recombinant Antigens VTI710 HCV Core, P. pastoris R01518 HCV NS-3 c33c Genotype 1a, E. coli Contains the main immunodominant region of HCV c33c /NS3 (a.a. 1192-1459) R8A116 HCV NS-4a+b, E. coli Contains a.a. 1658-1863 of the NS4 protein R18190 HCV NS-5 Genotype 1, E. coli Contains a.a. 2212-2313 of the NS5 protein R18523 HCV Nucleocapsid NS3/NS4/NS5, E. coli Contains immunodominant regions of the core, NS3, NS4 and NS5 proteins R01599 HCV Core NS3/NS4/NS5, E. coli Contains core fragment (a.a. 11-45), NS3 fragment (a.a. 1208-1430), NS4 fragment (a.a. 1885-1923), NS5 fragment (a.a. 2332-2423). Works as a capture antigen in a pair with R01600 R01600 HCV Core NS3/NS4/NS5, E. coli Contains core fragment (a.a. 11-53), NS3 fragment (a.a. 1210-1450, 1337-1483), NS4 fragment (a.a. 1888-1925), NS5 fragment (a.a. 2332-2423). Works as a detection antigen in a pair with R01599

HIV-1 & HIV-2 WHO Recommended: EIA or CLIA assay for HIV-1, 2 and Type O antibodies, can be used in combination of with HIV-1 p24 antigen detection. Recombinant Antigens R01593 HIV-1 C-Terminal gp120 + most of gp41, E. coli Reacts with all sera of HIV-1 and HIV-type O infected individuals and with 60-80% of HIV-2 infected individuals R01454 HIV-1 gp41 Type O, E. coli Reacts with human HIV type O positive serum VTI360 HIV-2 gp36, P. pastoris Contains a.a. 2212-2313 of the NS5 protein Antibodies C01653M MAb to HIV-1 p24, pair C01655M MAb to HIV-1 p24 , pair C65690M MAb to HIV-1 p24 , pair Treponema pallidum (Syphilis) WHO Recommended: EIA assay for specific treponemal antibodies (typically p15, p17, p42.5, p47 or TmpA). Recombinant Antigens R01681 T. pallidum p15/p17/p47, E. coli Works in double antigen sandwich immunoassays with R01682 as the detection antigen R01682 T. pallidum p15/p17/p47, E. coli Works in double antigen sandwich immunoassays with R01681 as the capture antigen R01705 T. pallidum p17/p15/p42.5/p47, E. coli Chimeric protein that contains fragments of p17, p15, p42.5 and p47 R01582 T. pallidum p15, E. coli Contains a GST- and His-tag at the N-terminus R01583 T. pallidum p17, E. coli Contains a GST- and His-tag at the N-terminus R8A201 T. pallidum p17, E. coli Contains Beta-galactosidase fused at the N-terminus R01606 T. pallidum p47, E. coli Contains a GST- and His-tag at the N-terminus R8A403 T. pallidum p47, E. coli Contains Beta-galactosidase fused at the N-terminus R01665 T. pallidum TmpA, E. coli Represents mature TmpA without the leader peptide. Contains a GST- and His-tag at the N-terminus R8A404 T. pallidum TmpA, E. coli Contains Beta-galactosidase fused at the N-terminus

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Additional Screening Recommended Malaria (Plasmodium Species) WHO Recommended: High sensitivity enzyme immunoassay for malaria antigens or antibodies. Recombinant Antigens R01602 P. vivax merozoite surface protein 1 (MSP1), E. coli Suitable as a capture antigen in ELISA R01604 P. vivax merozoite surface protein 1 (MSP1), E. coli Suitable as a capture antigen in ELISA R01440 P. vivax circumsporozoite protein (CSP), E. coli Represents 353 amino acids of the full length protein R01597 P. falciparum lactate dehydrogenase (pLDH), E. coli R01598 P. vivax lactate dehydrogenase (pLDH), E. coli

Zika FDA Recommended: NAT assay followed by confirmatory testing

for IgM antibody response. Recombinant Antigens 9050

Zero-X-React™ Zika Envelope Protein, Insect Cells Mutated to eliminate cross reactivity with other flaviviruses. Reacts with both IgG and IgM R01635 Zika Virus Envelope Protein, Insect Cells Includes the ectodomain of the envelope protein. Reacts with both IgG or IgM R01636 Zika Virus NS1 Protein, Insect Cells Reacts with both IgG or IgM CMV WHO Recommended: High sensitivity enzyme immunoassay for CMV-specific IgM antibodies. Native Antigens 7600 CMV IgG/IgM Partially purified by centrifugation (strain AD169) and propagated in human MRC-5 cells 7504 CMV-G Cell lysate of CMV (strain AD169) and propagated in human fibroblast cells 7507 CMV Grade III Partially purified CMV (strain AD169) and propagated in human fibroblast cells Recombinant Antigens R01561 CMV pp52 (UL44), E. coli Truncated antigen fused to His-tag at N-terminus. Suitable for IgG and IgM detection R01563 CMV pp150 (UL32), E. coli Truncated antigen fused to His-tag at N-terminus. Suitable for IgG and IgM detection

Chagas (Trypanosoma cruzi) WHO Recommended: High sensitivity enzyme immunoassay for Chagas antibodies. Recombinant Antigens R01587 T. cruzi 1F8, E. coli Contains a GST tag at the N-terminus R01589 T. cruzi FRA, E. coli Contains a GST tag at the N-terminus R01684 T. cruzi Chimeric 1, E. coli Polyprotein containing several unique immunodominant antigens. Can be used in combination with R01685 for sensitive and specific detection of Chagas R01685 T . cruzi Chimeric 2, E. coli Polyprotein containing several unique immunodominant antigens. Can be used in combination with R01684 for sensitive and specific detection of Chagas R01364 T. cruzi Chimeric Multiantigen (MACH) Polypeptide of 87 amino acids with epitopes PEP-2, TcD, TcE and SAPA HTLV WHO Recommended: High sensitivity enzyme immunoassay for HTLV-I/II antibodies. Recombinant Antigens R18142 HTLV-I Envelope Protein Represents C-terminal of gp46 and most of p21E (a.a. 165-440). Immunoreactive with both HTLV-I and HTLV-II positive sera. West Nile Virus CDC Recommended: NAT assay followed by confirmatory testing for WNV-specific IgM antibodies. Recombinant Antigens R8A104 West Nile Virus Envelope Protein, E. coli Contains N-terminal part of the envelope protein

Pairs

CAPTURE DETECTION C65690M C01653M C01655M C01653M C01655M C65690M C01247M B65811R C01248M B65811R C18286M C18212M

HIV-1 p24

HBV (HBsAg)

- Reversible

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Molecular Reagents Optimized RT-qPCR Master Mix

MDX025 Low LOD 1-Step RT-qPCR Mix Suitable for detecting RNA and DNA viruses at very low levels for applications such as blood bank or transplant viral testing. Novel buffer system optimized for multiplex assays. Perform first-stand DNA synthesis and qPCR in a single tube.

Product Performance Data: Low Limit of Detection (LOD) for both RNA and DNA Viruses

Amplification Curves Amplification Curves HIV-2 (5 IU/mL)

Amplification Curves plification Curves HCV (30 IU/mL) Amplification Curves

23.688 23.079 23.079 23.6 8

40.432

21.688 21.079 21.079 21.6 8

36.932

19.688 19.079 19.079 19.6 8

33.432

17.688 17.079 17.079 17.6 8

29.932

15.688 15.079 15.079 15.6 8

26.432

13.688 13.079 13.079 13.6 8

22.932

11.688 11.079 11.079 1.6 8

19.432

9.688 9.079 9.079 9.6 8

15.932

7.688 7.079 7.079 7.6 8

12.432

5.688 5.079 5.079 3.688 3.079 3.079 3.6 8 1.688 1.079 1.079 1.6 8 5.6 8

8.932

5.432

1.932

2 4 6 8 10 2 4 6 8 10 12

12 12

14 14 20 14

16 16

18 18 26

20 20

22 22

24 24 24

26 26

28 28

30 30

32 32 32

34 34 34

36 36 36

38 38 38

40 40 40

42 42 42

44 44 4

10 4 16

18

22

24

28

22 30 3

34

36

38

40

42

44

2

4

6

8

12

16

18

20

26

28

30

2

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6

8

10

2

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6

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10

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44

Cycles

Cycles

Cycles

Cycles

Cycles

Amplification Curves HAV (5 IU/mL) Amplification Curves

Amplification Curves HBV (15 IU/mL) Amplification Curves

23.688

6.628

21.688

6.028

19.688

5.428

17.688

4.828

15.688

4.228

13.688

3.628

11.688

3.028

9.688

2.428

7.688

1.828

5.688

1.228

3.688

0.628

1.688

0.028

2

4

6

8

10

12

14

16

18

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22

24

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32

34

36

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42

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40

42

44

Cycles

Cycles

Cycles

Cycles

B19 (60 IU/mL)

Amplification Curves Amplification Curves HIV-1 (60 IU/mL)

Amplification Curves

Amplification Curves

63.075

43.077

57.075

39.077

35.077

51.075

31.077

45.075

27.077

39.075

23.077

33.075

19.077

27.075

15.077

21.075

11.077

15.075

7.077

9.075

3.077

3.075

2

4

6

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Method: 24 replicates of purified blood viral extracts were tested in singleplex qPCR reactions using the Low LOD 1-Step RT-qPCR Mix at the indicated IU/mL. The singleplex reactions were HAV, HBV, HCV, HIV-1, HIV-2, Parvovirus B19. The amplification curve results illustrate that Low LOD 1-Step RT-qPCR Mix can be used with both RNA and DNA viruses as low as 5 IU/mL.

Sequencing Grade dNTPs Ready-to-use sequencing grade dNTPs available individually, as sets, or pre-blended dNTP mixes. Ultra-pure (>99% by HPLC) dNTPs supplied as lithium salts. Free of PCR inhibitors, DNase and RNase. For more information visit www.MeridianLifeScience.com.

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