NAT Yield from Real Time Testing of Organ Donors for HIV-1 RNA and HCV RNA Safer Organs and No False...
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Transcript of NAT Yield from Real Time Testing of Organ Donors for HIV-1 RNA and HCV RNA Safer Organs and No False...
NAT Yield from Real Time Testing of Organ Donors for HIV-1 RNA and HCV RNA
Safer Organs and No False Positive Results
Claudia Chinchilla-Reyes, MB(ASCP)1, Thomas D. Mone, MBA2, Monica Johnson3, Patricia Niles4 and Marek Nowicki, PhD1
1MNIT, Los Angeles, CA, 2OneLegacy, Los Angeles, CA, 3GSDS, Sacramento, CA, and 4NMDS, Albuquerque, NM.
No Disclosures
Background• Transplant professionals must be able to rely on
organ and tissue screening tests to accurately detect the presence of viruses and their antibodies.
• Recent data shows that there is higher likelihood of accepting organs from high-risk donors if Nucleic Acid Testing (NAT) had been performed. – (Kucirka, L. M. et al. Am. J.Transpl. 2009; 9(5): 1197-204).
Background
• Antibody tests may give false negative results due to the presence of HCV or HIV-1 infection during the “window” period.
• Nucleic Acid Testing (NAT) can reduce “window” donations during the antibody negative phase infection.
Aim
• To determine the prevalence of “NAT reactive only” aka “NAT yield” donors among organ donors in the Western United States.
Methods
• Assay: Procleix HIV-1/HCV TMA (Novartis/GenProbe, San Diego, CA)
• Region: California, Nevada, Oregon, Washington, New Mexico and Utah.
• Period: Sept 2004 - October 2011
• Donors: 8204 prospective organ donors for HIV-1 and HCV RNA.
Results
• We identified 3 (0.04%) cases of NAT reactive donors with no HIV-1 or HCV serological markers.
• All cases were terminated and no organs were recovered.
Case 1 (December 2004)
• 23 Year’s old male from Northern California
• Anti-HIV-1/2: NonReactive
• Anti-HCV: NonReactive
• HIV-1/HCV Procleix Assay: Repeatedly Reactive
• HIV-1 discriminatory Procleix Assay: NonReactive
• HCV discriminatory Procleix Assay: Presumed HCV reactive*
• Case terminated, no organs recovered.
• Risk factors: pending chart abstraction
*QNS (Quantity Not Sufficient)
Case 2(March 2008)
• 40 Year’s old male from Southern California
• Anti-HIV-1/2: NonReactive
• Anti-HCV: NonReactive
• HIV-1/HCV Procleix Assay: Repeatedly Reactive
• HIV-1 discriminatory Procleix Assay: Repeatedly Reactive
• HCV discriminatory Procleix Assay: NonReactive
• Case terminated, no organs recovered.
• Risk Factor: Donor had drug use and incarceration history.
Case 3(November 2008)
• 24 Year’s old Male from New Mexico
• Anti-HIV-1/2: NonReactive
• Anti-HCV: NonReactive
• HIV-1/HCV Procleix Assay: Repeatedly Reactive
• HIV-1 discriminatory Procleix Assay: NonReactive
• HCV discriminatory Procleix Assay: Repeatedly Reactive
• Case terminated, no organs recovered.
• Risk Factor: Donor institutionalized (Mental Institution)
NAT Reactive Cases
Case Date Age Gender Origin HIV & HCV
Serology
HIV-1/HCV NAT
HIV-1 disc HCV disc Risk Factor
1 Dec 2004
23 M N. Cal Non - Reactive
Repeatedly Reactive
Non - Reactive
HCV* Pending
2 Mar 2008
40 M S. Cal Non - Reactive
Repeatedly Reactive
Repeatedly Reactive
Non - Reactive
Drug use and incarceration
3 Nov 2008
24 M NM Non - Reactive
Repeatedly Reactive
Non - Reactive
Repeatedly Reactive
Institutionalized
*Presumed HCV reactive, Quantity Not Sufficient
Results (2)
• All other NAT reactive cases had serological markers for HIV-1 and HCV.
Serology Prevalence *
*Chinchilla-Reyes, et al. abstract #1066, ATC 2012
HCV HIV
2010 6.5% 0.2%
2011 5.7% 0.3%
......But what about false positives?
How did we avoid them?
False Positives v. Non-Repeatable
Definitions
• False NAT Positive: specimen that is consistently NAT reactive but in fact the virus is not present in the specimen and/or organ donor.
• Non-Repeatable: discordant specimens results that initially tested reactive, retested non-reactive.
Testing:
• Real-time, no batching • Neat (undiluted) • Diluted 1:5 with PBS (manufacturers
recommendation)• Discrimination step if reactive• if needed, retesting was performed from an
untouched, virgin reference vial of serum
MNIT NAT Algorithm
=
“NAT+ only” results compared with serology and donor risk factors and if necessary repeated from untouched vial
•Our data shows that the prevalence of “NAT only” reactive donors is approx. 0.04% in the Western United States.
•2 out of the 3 cases had high risk factors for HCV and HIV-1.
•NAT testing potentially prevented multiple transmissions of HCV and HIV-1.
Conclusions
Conclusion (2)
• Contrary to prevailing opinion that NAT produce many false positive results increasing loss of organs, these events are rare in a properly designed and QA lab with the properly chosen assay.
Based on our 7 year experience:
Don’t relay on single NAT result - develop proper algorithm, we don’t relay on single EIA test don’t we?!
Evaluate NAT and serology and if necessary repeat from untouched, virgin vial.
To date there have been NO organs defer simply because of false positive results from our lab.
Thank you!Acknowledgments
•MNIT for support & encouragement to perform the study
•MNIT lab staff collaboration
•OPO’s •OneLegacy •Golden State Donor Services•New Mexico Donor Services
•ATC for inviting us to present this data.