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
HIV-1 Detection:
(Window Period in Days)
(Window Period in Days)
HCV Detection:
(Window Period in Days)
(Window Period in Days)
HBV Detection:
(Window Period in Days)
(Window Period in Days)
References:
- Procleix Ultrio Elite Assay Package Insert, 503049EN Rev A (exUS).
- Weusten J, et al. Transfusion. 2002;42(5):537-548.
- Weusten J, et al. Transfusion. 2011;51(1):203-215.
- 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:
- Procleix Ultrio Elite Assay Package Insert, 503049EN Rev A (exUS).
- Weusten J, et al. Transfusion. 2002;42(5):537-548.
- Weusten J, et al. Transfusion. 2011;51(1):203-215.
- Sauleda, S. Advances in NAT Automation – A Presentation on Novartis Sponsored Trials, July 2012