Molecular Diagnostics

Providing Best-in-class Molecular Pathology

Nucleic Acid Amplification Testing (NAT)

NAT is the latest advanced technology in screening blood for infectious viruses such as Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV).

  • Highly sensitive and specific: targets specific viral nucleic acid sequences that may be present in donated blood.
  • Detects very low levels of viral RNA or DNA.
  • Therefore, NAT:
    • Shortens the Window Period from infection to detection.
    • Helps prevent transfusion-transmitted diseases.
    • Provides additional layer of safety to the blood supply.

NAT: Redefine Safety in Blood Screening

  • Patient’s choice for an infection-free recovery is of critical importance.
  • Despite improvements in HIV, HCV and HBV serological tests in recent years, incidences of viral transmission via blood transfusion still occur because donations that take place while a donor is:
    • In the pre-seroconversion window phase;
    • Infected with immunovariant viruses; or
    • A non-sero-converting chronic carrier.
  • Direct, sensitive detection of viral nucleic acid substantially decreases the incidence of transfusion-transmitted infections.

NAT Testing Solution at Synapse

  • Internationally certified blood screening assay: PROCLEIX® ULTRIO® Elite Assay by Grifols (formerly Novartis Diagnostics).
  • High-throughput testing yet still provide fast turnaround time.
  • Unique and specially designed molecular testing facility certified and approved by Grifols.
  • Qualified staff trained and certified by Grifols.

NAT Significantly Reduces the Risk of Transfusion-Transmitted Infections

NAT Ultrio Elite
Ab or Ag
HIV-1 Detection:
(Window Period in Days)
4.5 4.5
4.5 15.0 - p24 Antigen
HCV Detection:
(Window Period in Days)
2.2
4.5 58.3 - HCV Ab
HBV Detection:
(Window Period in Days)
16.3
38.3 - HBsAg
References:
  1. Procleix Ultrio Elite Assay Package Insert, 503049EN Rev A (exUS).
  2. Weusten J, et al. Transfusion. 2002;42(5):537-548.
  3. Weusten J, et al. Transfusion. 2011;51(1):203-215.
  4. Sauleda, S. Advances in NAT Automation – A Presentation on Novartis Sponsored Trials, July 2012
Identify HBV, HCV and/or HIV cases in much shorter window periods than immunoassays.

Excellent Specificity and Analytical Sensitivity

100% clinical sensitivity for HIV-1, HCV and HBV

Clinical sensitivity of the Procleix ® Ultrio Elite ® assay in known positive samples
All (N = 620) HIV-1 (N = 214) HCV (N = 203) HBV (N = 203)
Undiluted sample, % (95% CI) 100 (99.4 — 100) 100 (98.3 — 100) 100 (98.2 — 100) 100 (98.2 — 100)

Demonstrated specificity

99.90% specificity in 8,011 fresh and frozen normal blood donor plasma samples

High assay performance

Detection probabilities (IU/mL)
Panel tested 50% (95% fiducial limits) 95% (95% fiducial limits)
HIV-1 WHO (97/650) 5.4 (4.5 to 6.1) 18.0 (15.0 to 23.5)
HIV-2 WHO (08/150) 2.6 (2.3 to 3.0) 10.4 (8.9 to 12.6)
HCV WHO (06/100) 0.9 (0.8 to 1.0) 3.0 (2.5 to 2.9)
HIV-2 WHO (08/150) 0.9 (0.8 to 1.1) 4.3 (3.8 to 5.0)
References:
  1. Procleix Ultrio Elite Assay Package Insert, 503049EN Rev A (exUS).
  2. Weusten J, et al. Transfusion. 2002;42(5):537-548.
  3. Weusten J, et al. Transfusion. 2011;51(1):203-215.
  4. Sauleda, S. Advances in NAT Automation – A Presentation on Novartis Sponsored Trials, July 2012

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