our tryst with nucleic acid testing dolly daniel, dept of transfusion medicine, cmc, vellore
TRANSCRIPT
![Page 1: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/1.jpg)
Our tryst with Nucleic Acid Testing
Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore
![Page 2: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/2.jpg)
CMC, Vellore
• A Large mission hospital• > 100 years old• Over 2200 IP beds• Over 6000 OP a day• About 75000 units of
blood / components- annual usage
• Strong component of education / service and research
![Page 3: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/3.jpg)
BB- Id Testing
• Only Hepatitis B testing
• 1988 – HIV
• 1997 – HCV
• All testing initiated before testing became mandatory for licensing
![Page 4: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/4.jpg)
![Page 5: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/5.jpg)
Why NAT at CMC???
• Donor spread
• Seropositivity
• Anecdotal incidents of seroconversion
![Page 6: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/6.jpg)
• The American Red Cross accepts blood donations only from volunteer donors.
•
• Among Red Cross donors in a given year, 19 percent donate occasionally, 31 percent are first-time donors, and 50 percent are regular, loyal donors.
![Page 7: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/7.jpg)
Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic Acid–
Amplification Testing -NEJM 2004
37,164,054 units screened Negative on serology
12 positive for HIV-1 RNA (1 in 3.1 million) (2 of which were detected by HIV-1 p24 antigen)
170 positive for HCV RNA ( 1 in 230,000)
The respective rates of positive HCV and HIV-1 nucleic acid–amplification tests were 3.3 and 4.1 times as high among first-time donors as among donors who gave blood repeatedly
Follow-up studies of 67 HCV RNA–positive donors demonstrated that seroconversion occurred a median of 35 days after the index donation
Three cases of long-term immunologically silent HCV infection were documented
![Page 8: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/8.jpg)
Donor Profile
• Almost 70% are replacement donors
• In the West – 100% Voluntary
• Repeat donors? ??
• Process of deferral / self deferral / temporary / permanent and attitudes - very different
![Page 9: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/9.jpg)
Linear Trend line
![Page 10: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/10.jpg)
Linear Trend line
![Page 11: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/11.jpg)
Issues
• Patient Safety
• (Staff requesting better ID screens)
• Quality of blood products
• One product being issued to even 5 babies
![Page 12: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/12.jpg)
.Eskimo: "If
I did not know about God and sin, would I go to hell?"
Priest: "No, not if you did not know."
Eskimo: "Then why did you tell me?"” Annie Dillard
![Page 13: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/13.jpg)
The Indian Experience – IJMR Feb 2008
![Page 14: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/14.jpg)
India and NAT
• Total no of samples: 12224
• Replacement donors : 8999
• Voluntary donors : 3225
• Seropositivity - 0.26% – HIV,
0.33% HCV, 1.12% HBV
![Page 15: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/15.jpg)
Seronegative but NAT positive
• Yield - 8 / 12224
• Overall positivity – 1/1528 donations
• HIV - 1/ 12224
• HCV / HIV 1 co infection- 1/12224
• HBV – 6/12224
![Page 16: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/16.jpg)
NAT testing would prevent
• 3272 infectious transfusions
• 818 HIV infected units
• 409 HCV infected units & 2454 HBV infected units from being transfused.
• If components are being processed – then double or triple these numbers
![Page 17: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/17.jpg)
Translation to the CMC scenario
• Our donor distribution is very similar
• We have about 27000 donors bled each year X 2 / 3 components
• Approx 1/1500 transfusions infected
• Therefore about 35 of our patients are being infected annually by TTIs.
• (calculation of 2 components per donation)
![Page 18: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/18.jpg)
CMC Stats -2007-2008
IJMR seropos
CMC
seropos
IJMR
(NAT yield)
CMC Projected
HIV 32 (0.26%)
70 (0.17%) 2 NAT pos /32 seropos
12 (4x3)
HBV 137 (1.12%)
488(2.19%) 6 NAT pos /137 seropos
54 (18x3)
HCV 40 (0.33%)
214(0.96%) 1 NAT pos /40 seropos
15 (5x3)
![Page 19: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/19.jpg)
Institution
• 3 years ……..
• Justified
• Negotiated
• Presentations to clinicians
![Page 20: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/20.jpg)
The process
• Challenges
• Infrastructure and space requirements
• Cost impact
![Page 21: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/21.jpg)
Assessments
• Projected numbers of possible yields
• Health technology assessment
• Permitted on a trial basis
![Page 22: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/22.jpg)
• "The trouble with jogging is that by the time you realize you're not in shape for it, it's too far to walk back." Franklin Jones
![Page 23: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/23.jpg)
The interim we waited…..
• No substitute for repeat voluntary donors
• No substitute for the practice of appropriate and rational use of blood
![Page 24: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/24.jpg)
The Numbers
• Total Donors Screened – 26500
• Sero positives – 594
• Sero Negative - 25906
![Page 25: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/25.jpg)
Seropositives
• HIV – 51 ( 0.18%)• HBV – 364 ( 1.30%)• HCV –179 ( 0.67%)
• Seropositive NAT Negative - 252• HIV – 37• HCV – 166• HBV - 49
![Page 26: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/26.jpg)
• Total seronegative units NAT positive – 68
• Positive on repeat testing and discriminatory assays - 28 (0.105%) 1 per 950 donors approx)
![Page 27: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/27.jpg)
Spread of positives
HBV 22
HCV 3
HBV & HCV 2
HIV 1
![Page 28: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/28.jpg)
One time positives and their significance?
• ? False positives
• ? Low viral loads – Poissonian distribution
• Follow up recommended ?
![Page 29: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/29.jpg)
Is it worth continuing?
• Cost per prevented infection
• At the cost of what?
![Page 30: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/30.jpg)
• He who sleeps on the floor will not fall off the bed. Robert Gronock.
• .
![Page 31: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/31.jpg)
In the context of transfusion services
• Has to be driven in the context of each individual institution
• Accessibility missing …… NAT available
• Basics of safe donor recruitment and appropriate use of blood and components
![Page 32: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/32.jpg)
To conclude
• NAT seems to have worked for us…
• The confirmation of NAT yields is worth following up
• Working up samples which are one time NAT reactive – a must
![Page 33: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/33.jpg)
Above all
• Each institution needs to thrash out the issue for itself
• Imperative that simple and safety measures like repeat voluntary donor recruitment and rational use of blood be focused upon alongside
![Page 34: Our tryst with Nucleic Acid Testing Dolly Daniel, Dept of Transfusion Medicine, CMC, Vellore](https://reader036.vdocument.in/reader036/viewer/2022062422/56649f2a5503460f94c43e9d/html5/thumbnails/34.jpg)