Lennart Friis-Hansen Dept. of Clinical Biochemistry Rigshospitalet Univeristy of Copenhagen Denmark...
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Transcript of Lennart Friis-Hansen Dept. of Clinical Biochemistry Rigshospitalet Univeristy of Copenhagen Denmark...
Lennart Friis-HansenDept. of Clinical Biochemistry
RigshospitaletUniveristy of Copenhagen
Denmark
First trimester screeningThe Danish Experiences
Vårmötet 2007
Borås, May 11th, 2007page 2
First trimester screening in Denmark
Historical overview of thePrenatal screening in Denmark
– Early 1970s First antenatal diagnosis of DS– 1978 Introduction of national guidelines for when offer
karyotyping All women > 35 years Women with known risk factors:
Previous birth of a child with karyotype anomalies Carrier state of a known disease, e.g. thalassemia, CF,
– 1980 Screening for NTD using MS-AFP and ultrasound– 1990 Screening for DS using MS-AFP, HCG and uE3 as
part of trials in parts of Denmark
Borås, May 11th, 2007page 3
First trimester screening in Denmark
DS epidemiology – problems with the old screening policy
In the late 1990s and early 2000s the overall invasive rate reaches 10-12 % for all pregnancies.
– 40% detection rate– 60% of the Downs being
born by women < 35 years of age.
Borås, May 11th, 2007page 4
First trimester screening in Denmark
Types of tests
1st trimester– Combined test (“Double test”
+ NT) free β-hCG, PAPP-A, NT and maternal age
2nd trimester– Triple test
AFP, uE3, total hCG/free β-hCG and maternal age.
– Quadruple test AFP, unconjugated oestriol
(uE3), free β-hCG/total hCG, inhibin-A and maternal age.
1st + 2nd trimester– Integrated test
a single test result = the integration of NT and PAPP-A in the first trimester + the quadruple test in the second.
– Serum integrated test A variant of the integrated
test using serum markers only
Suruss, 2003
1st trimester 2nd trimesterWeek 8 - 14 11 – 14 15-18 PAPP-A/hCG NT AFP, uE3, βhCG/hCG, inhibin-A
Borås, May 11th, 2007page 5
First trimester screening in Denmark
Performans af forskellige screeningsstrategier
Screen positive (%)
Detection rate (%)Integreret (1+2 trim)
NT + doubletest(1 trim)
NT (1 trim)
Doubletest (1 trim)
Quadrupletest (2 trim)
Tripletest(2 trim)
Alder > 34 år(1 trim)
Ingen test
Simulation by H. Cuckle
Borås, May 11th, 2007page 6
First trimester screening in Denmark
Types of tests
Why 1st trimester screening is preferred– Faster result -> the pregnant women have less time in which
to worry– If needed abortion can be performed almost within limits for
“free abortion”– High % of attendance because: Pregnant women want to see
the baby – they accept the NT as part of “seeing the baby”. However, once they’ve seen it, they are less likely to come back.
– (Programs combining 1st and 2nd trimester screening suffer from patients not attending the 2nd trimester screening.)
1st trimester 2nd trimesterWeek 8 - 14 11 – 14 15 - 20 PAPP-A/hCG NT AFP, uE3, βhCG/hCG, inhibin-A
Borås, May 11th, 2007page 7
First trimester screening in Denmark
Initial questions from the Danish National board of health
– Can foreign programs be copied?– can their performance be achieved?
Borås, May 11th, 2007page 8
First trimester screening in Denmark
1st Trimester screening trials in Denmark
Copenhagen first trimester study (HS) (1997-2001) (Wøjdeman et al., 2005)
Intervention study – by NT only– NT was measured in 8622 singleton pregnancies (97.5% of the
screened cases) GA 10 + 3 and 13 + 6 weeks. DR for DS with NT alone 75%, FPR 1.8%.
– beta-hCG and PAPP-A were analyzed in 6441 cases. DR 73%, FPRs of 8.8%
– the combined test (NT + biochemistry) DR 91%, FPR 2.1%– Low beta-hCG and PAPP-A values (below 0.4 MoM) were observed in
0.5% of the women including all cases of triploidy and trisomy 18 and 13.
Skejby study (Schøidt et al., 2006)Intervention study by Double + NT– 881 had the full test. – Screen positive = 34. – CVS with aneuploidy = 11 (6 trisomy-21, 5 others).– FPR = 3.2%. Positive Predictive Value (PPV) = 17.6% for T-21.
Bent Nørgaard-Pedersen and Michael Chistriansen, both Statens Serum Institut
Borås, May 11th, 2007page 9
First trimester screening in Denmark
Antenatal care in Denmark2004/5 ->
• Week 8-10 (-12) GP (confirmatory) pregnancy testing, general information about the pregnancy and information 1st trimester scrrening program for DS
• Week 8-10 (-12) Blood sampling for biochemistry performed at GP or at the hospital
• Week 11-13+6 NT (maybe one-stop)• If screen positive CVS/AC
• Week 18-20 malformation screening by ultrasound
”Fetal Diagnostics and Risk Evaluation” A report from Danish National Board of Health, April 1st
2003
Borås, May 11th, 2007page 10
First trimester screening in Denmark
National guidelines for quality assurance of the 1st trimester screening
– Ultrasound Certification of sonographers Continuous monitoring (>500 scan/year) Each centre should handle at least 1,000 deliveries per year
– Biochemistry Internal & external quality control Minimal number of test required
> 5,000 tests/year -> the laboratory can operate independently < 5,000 tests/year -> the laboratory can only operate if they
collaborate with a another laboratory on quality assurance– Screening program performance
Screen positive rates should be monitored False negative rates should be monitored A National center for monitoring the quality of the program
should be established
Borås, May 11th, 2007page 11
First trimester screening in Denmark
Implementation of 1. trimester screening NT + biochemistry
Copy the FMF program to the very point =>
– known screen positive rates
– Known detection rates
Borås, May 11th, 2007page 12
First trimester screening in Denmark
Implementation of 1. trimester screening NT + biochemistry
The sonography followed FMF guidelines– NT had already been established at several
centers Major Departments of Fetal medicine performing the NT
had all been trained by the Fetal Medicine Foundattion, London, all sonographers were already FMF-certified.
– NT QC All sonographers are FMF certified
– Software All Departments of Fetal medicine were using the
Astraia software (FMF approved)
Borås, May 11th, 2007page 13
First trimester screening in Denmark
Implementation of 1. trimester screening NT + biochemistry
Biochemistry – Exclusively performed at Depts. of Clinical
biochemistry It was decided to follow the FMF standards and only
use FMF certified platforms because only data generate using these platforms can be entered into the Astraia software
Brahms Kryptor Perkin Elmer Delphia Systems
– QC Internal and external controls. All Depts. Of Clinical biochemistry are participating in
the UK-NEQAS 1. trimester QC program Monitor screenpostive rate Monitor medians MoM
Borås, May 11th, 2007page 14
First trimester screening in Denmark
Implementation of 1. trimester screening NT + biochemistry
Risk estimation All centers performing NT sonography use the
Astraia software Biochemical data generated using FMF approved
platforms can be entered directly into Astraia Astraia could be used for risk estimation Astraia could be used for quality assurance.
Borås, May 11th, 2007page 15
First trimester screening in Denmark
Setup
Week 8 - 13+6•PAPP-A + hCG•Patient ID (age)
Week 11 - 13+6•NT•Weight•Gestational age•Additional risk factors
CALCULATE RISK
Borås, May 11th, 2007page 16
First trimester screening in Denmark
Challenges - 1
– Astraia The window for which biochemistry is accepted in
Astraia Expanded from 10+0 – 13+6 to 8+0 – 13+6 in 2005
Inability of Astraia to communicate with the Hospital Laboratory Information Management System
All data have to be manually entered into Astraia. This is associated with a great risk for typing mistakes.
Astraia are currently working on making the necessary changes – deadline?
Borås, May 11th, 2007page 17
First trimester screening in Denmark
Challenges - 2
– Default medians – can they be used Initial study 1500 samples analyzed at Hvidovre and
Rigshospitalet -> Yes Follow-up 20000 samples analyzed at Hvidovre and
Rigshospitalet -> Yes but ability to modify medians would be preferable
Borås, May 11th, 2007page 18
First trimester screening in Denmark
50 60 70 80 90 1000
10
20
30
40
50
60
70
80
90Astraia program (new)
SKS (56-69) + HH+RH (70-97)
a
Gestational age, days
hC
G , I
U/l
-10
-5
0
5
10 SKS (56-69) + HH+RH (70-97)
Gestational age, days
60 70 80 90
hCG median +/-5 %
b
hC
G , I
U/l
Borås, May 11th, 2007page 19
First trimester screening in Denmark
50 60 70 80 90 1000
1
2
3
4
5
6
SKS (56-69) + HH+RH (70-98) Astraia program
a
Gestational age, days
PA
PP
-A
, IU
/l
-0.4
-0.2
0.0
0.2
0.4
SKS (56-69) + HH+RH (70-98)
Gestational age, days
60 70 80 90
PAPP-A median +/- 5 %b
PA
PP
-A
, IU
/l
Borås, May 11th, 2007page 20
First trimester screening in Denmark
20
05
-12
00
5-2
20
05
-32
00
5-4
20
05
-52
00
5-6
20
05
-72
00
5-8
20
05
-92
00
5-1
02
00
5-1
12
00
5-1
22
00
6-1
20
06
-22
00
6-3
20
06
-42
00
6-5
20
06
-62
00
6-7
0.85
0.90
0.95
1.00
1.05
1.10
1.15
1.20
1.25b-hCGPAPP-A
Måned
Me
dia
n M
oM
Monthly median MoM
Borås, May 11th, 2007page 21
First trimester screening in Denmark
Conclusion Medians
– Medians can be used during start up phase of a first triemster program.
– The bigger Danish centres would like to be able to individualise the Kryptor medians (scheduled to take place with the next Astraia update)
– The Delphia Express medians needed a major adjustment (which has taken place)
Borås, May 11th, 2007page 22
First trimester screening in Denmark
Challenges - 3
– Pre-analytical – can samples be sent by mail to the laboratories Pilot experiment Compare medians
Borås, May 11th, 2007page 23
First trimester screening in Denmark
Summer temperatures in Denmark
Borås, May 11th, 2007page 24
First trimester screening in Denmark
Temperatures, July 1st-4th, 2005
Borås, May 11th, 2007page 25
First trimester screening in Denmark
free-beta PAPP-A0.90
0.951.00
1.05
1.10
1.151.20
1.25
Rat
io a
fter
72
hrs
in
mai
l v
s 72
hrs
at
4C
Borås, May 11th, 2007page 26
First trimester screening in Denmark
50 60 70 80 90 1000
102030405060708090
100
Astraia program
HH juni05-maj06
SKS feb05-aug05RH juli05-maj06
a
gestational age, days
hC
G , IU
/l
50 60 70 80 90 1000
1
2
3
4
5
6 Astraia program
HH juni05-maj06
RH juli05-maj06
SKS feb05-aug05
b
gestational age, days
PA
PP
-A
, IU
/l
No differences between medians– No differences
between medians obtained at a center that receive samples by mail and centers collecting and analyzing samples in house.
Borås, May 11th, 2007page 27
First trimester screening in Denmark
Conclusions transport
– Sending the samples to the laboratories using mail does not affect medians.
– However, care should be taken to avoid exposing samples to high temperatures.
Borås, May 11th, 2007page 28
First trimester screening in Denmark
Danish centers performing 1. trimester screening
23
1. Trimester NT only, externalsource for Biochemistry
1. Trimester NT + Biochem (Delphia)1. Trimester NT + Biochem (Brahms)
Borås, May 11th, 2007page 29
First trimester screening in Denmark
2003
County NT NT BC Malform. NT+BC Malform.
Northern Jutland all yes yes Only yes yes
Viborg County >35 + wish yes yes indication yes yes
Western Jutland >35 + wish april '05 yes yes yes yes
Ribe County >35 + wish > 35 yes yes yes yes
Vejle County >35 + IVF + wish yes yes yes yes yes
Southern Jutland few few tripletest no no no
Århus >35 ja > 35 no yes yes
Funen >35 March '05 March '05 ? yes yes
Western Zealand 0 March '05 No indication yes no
Northern Zealand 0 Yes Yes indication yes yes
Roskilde >35 January '05 yes indication yes yes
Southern Zealand >35 No No indication no no
Copenhagen County >35 + wish January '05 January '05 yes yes yes
Bornholm 0 yes yes no yes yes
Copenhagen City all yes yes yes yes yes
Fall 2004 Fall 2005
K Sundberg, unpublished data
Borås, May 11th, 2007page 30
First trimester screening in Denmark
The expected volumne at Danish centres performing the biochemistry (-hCG and PAPP-A)
– North Jutland, Aalborg 4000 tests/year
– Western Jutland, Holstebro 3500 tests/year
– Mid Jutland, Skejby 12000 tests/year
– Southern Jutland, Sønderborg 4000 tests/year
– Funen, Vejle 6000 tests/year
– National Serum Institute ? tests/year
– Northern Zealand, Hillerød 5000 test/year Copenhagen
County Gentofte 2000 tests/year Herlev 2000 tests/year Glostrup 2000 tests/year
– Copenhagen City Hvidovre 6000 tests/year Rigshospitalet 5000 tests/year
– Roskilde 3000 tests/year
– Western Zealand, Slagelse 2000 tests/year
– Southern Zealand, Næstved 3000 tests/year
Borås, May 11th, 2007page 31
First trimester screening in Denmark
Regimes at the centers
– One stop Samples drawn and NT performed at the same day at
the hospital in weeks 11-13+6 (Copenhagen County)
– Two stop Samples drawn at the GP in weeks 8-10, NT 11-13+6
at the Hospital (most hospitals) Samples drawn at the hospital in weeks 8-13+6, NT
11-13+6 at the Hospital (Hvidovre and Rigshospitalet)
– Risk calculation Only the final risk is calculated. An independent risk based on PAPP-A and -hCG is
NOT calculated
Borås, May 11th, 2007page 32
First trimester screening in Denmark
How the pregnant women chooseAccept to be screened
Yes > 80% RH
Accept having a CVS if screen positive
Yes - CVS
Wants a diagnostic despite a low risk estimate
Few
Choses abortion after the fetus has been found to carry trisomi 21
All but one!
Borås, May 11th, 2007page 33
First trimester screening in Denmark
Number of test per month in 2005 at Rigshospitalet
0
100
200
300
400
500
600
1 2 3 4 5 6 7 8 9 10 11 12
total
K Sundberg, unpublished data
Borås, May 11th, 2007page 34
First trimester screening in Denmark
Percentage not enroling 6% - 8% • Late bookers • Ethnic minorities • Unaware of the screening program• Don’t wish to be screened (few)
K Sundberg, unpublished data
Reasons for not enroling in the first trimester screening
Borås, May 11th, 2007page 35
First trimester screening in Denmark
Invasive procedures in Denmark
0
1000
2000
3000
4000
5000
6000
7000
8000
2000 2001 2002 2003 2004 2005 2006
12.2% 5.0%
Borås, May 11th, 2007page 36
First trimester screening in Denmark
Number of invasive tests i Copenhagen City
0
200
400
600
800
1000
1200
1400
Total Age DS
20012002200320042005
K Sundberg, unpublished data
Borås, May 11th, 2007page 37
First trimester screening in Denmark
Newborns with Down syndrome
0
10
20
30
40
50
60
70
2000 2001 2002 2003 2004 2005 2006
Tabor, 2007
Borås, May 11th, 2007page 38
First trimester screening in Denmark
1st trimester questionaire, Jan 04 - April 05
Number of children? – 59% - 72% nullipara
From where did you get the information about the 1. trimester screening?
– 58% - 81% GP– 12% - 14% friends– 8% - 10% media– 7% - 10% internet– 4% - 5% previous contact with health services– 1% - 3% Midwifes– 8% - 16% unanswered / other– – 12% - 8% Acknowledge more than one source
K Sundberg, unpublished data
Borås, May 11th, 2007page 39
First trimester screening in Denmark
Future tasks
– Establishment of a national QC database which will pair data from Astraia
NT data Biochemistry data
The Danish Cytogenetic Central register (DCCR) National patient register (LPR) which includes data
from the Danish newborn register and the Danish abortion register
– Better information to the pregnant women
Borås, May 11th, 2007page 40
First trimester screening in Denmark
New markers and new strategies
– ADAM12– Contingent testing– Repeated measurement
Borås, May 11th, 2007page 41
First trimester screening in Denmark
Borås, May 11th, 2007page 42
First trimester screening in Denmark
Christiansen, 2002
Borås, May 11th, 2007page 43
First trimester screening in Denmark
PAPP-A MoM
1Time
First Trimester
Second Trimester
D Wright, 2006
-hCG MoM
Time
1
First Trimester
Second Trimester
Borås, May 11th, 2007page 44
First trimester screening in Denmark
Borås, May 11th, 2007page 45
First trimester screening in Denmark
Conclusions
– It has been possible to offer all pregnant women first trimester screening in Denmark by Duplicating an existing well proven program (for
instance the FMF program) Having well educated staff
Nuchal translucency Biochemistry
Adhering to the strict quality control rules (e.g. the rules set up by the FMF)
Nuchal translucency Biochemistry
Choosing components that work well together Software Analytical platform
Borås, May 11th, 2007page 46
First trimester screening in Denmark
Acknowlegdements
– Karin Sundberg, Rigshospitalet– Ann Tabor, Rigshospitalet– Connie Jørgensen, Rigshospitalet
– Niels Tørring, Skejby Hospital– Steen Sørensen, Hvidovre Hospital
Borås, May 11th, 2007page 47
First trimester screening in Denmark
Thank you for your attention
Borås, May 11th, 2007page 48
First trimester screening in Denmark
PAPP-A66
-166
-266
-367
-167
-267
-368
-168
-268
-369
-169
-269
-370
-170
-270
-371
-171
-271
-372
-172
-272
-373
-173
-273
-374
-174
-274
-375
-175
-275
-376
-176
-276
-377
-177
-277
-378
-178
-278
-379
-179
-279
-3
0.80
0.85
0.90
0.95
1.00
1.05
1.10
1.15
1.20Hospital 1Hospital 2Hospital 3Hospital 4Hospital 5
DK-ratio
QC shipment
Rat
io
Danish QC values
Borås, May 11th, 2007page 49
First trimester screening in Denmark
50 55 60 65 70 75 80 85 90 95 1000
1
2
3
4
5
6
PAPP-A i Astraia program (new)
Hosptial 1 Median
Hosptial 2 Median
Hosptial 3 Median
gestational age, days
PA
PP
-A,
IU/l
Borås, May 11th, 2007page 50
First trimester screening in Denmark
Outline
– How it was Prevention oriented, age determined
– The new policy Informed Choice
– Implementation Choice of program to chose Choice of analytical platform
– Status 2006 Where are we in Denmark
– New markers and new strategies
Borås, May 11th, 2007page 51
First trimester screening in Denmark
Outline
– How it was Prevention oriented, age determined
– The new policy Informed Choice
– Implementation Choice of program to chose Choice of analytical platform
– Status 2006 Where are we in Denmark
– New markers and new strategies
Borås, May 11th, 2007page 52
First trimester screening in Denmark
Danish centers performing 1. trimester screening
23
1. Trimester NT only, externalsource for Biochemistry
1. Trimester NT + Biochemistry (Delphia)1. Trimester NT + Biochemistry (Brahms)
1. Trimester NT + Biochemistry (Brahms)starting up
Borås, May 11th, 2007page 53
First trimester screening in Denmark
2003
County NT NT BC Malform. NT+BC Malform.
Northern Jutland all yes yes Only yes yes
Viborg County >35 + wish yes yes indication yes yes
Western Jutland >35 + wish april '05 yes yes yes yes
Ribe County >35 + wish > 35 yes yes yes yes
Vejle County >35 + IVF + wish yes yes yes yes yes
Southern Jutland few few tripletest no no no
Århus >35 ja > 35 no yes yes
Funen >35 March '05 March '05 ? yes yes
Western Zealand 0 March '05 No indication yes no
Northern Zealand 0 Yes Yes indication yes yes
Roskilde >35 January '05 yes indication yes yes
Southern Zealand >35 No No indication no no
Copenhagen County >35 + wish January '05 January '05 yes yes yes
Bornholm 0 yes yes no yes yes
Copenhagen City all yes yes yes yes yes
Fall 2004 Fall 2005
K Sundberg, unpublished data
Borås, May 11th, 2007page 54
First trimester screening in Denmark
Performance
– 4% screen positive rate– Due to the low number of undected DS, the
detection rate is difficult to estimate at present. However it seems to be between 80-95%, but numbers are still to small to allow for a proper evaluation at the different centers.
Borås, May 11th, 2007page 55
First trimester screening in Denmark
– )– NT– Biochemical markers– Nick Wald introduces the MoMs (multiples of
meadian
Borås, May 11th, 2007page 56
First trimester screening in Denmark
Borås, May 11th, 2007page 57
First trimester screening in Denmark
Borås, May 11th, 2007page 58
First trimester screening in Denmark
The general idea
– Chromosome aberrations and/or developmental abnormalities lead to altered secretions of peptides/proteins from the placenta
– The maternal plasma concentration of these analytes can be measured
– These results can be used for Screening Diagnosis
Borås, May 11th, 2007page 59
First trimester screening in Denmark
PAPP-A
– IGF4BP protease– Secreted by the trophoblast– Released directly into maternal serum (not
present in amniotic fluid)– Detectable at ~6 wks of pregnancy– Doubles every 6 days– Increases to plateau at 14 wks – Decreased levels in Downs (0.3 -0.4 MoM)
Borås, May 11th, 2007page 60
First trimester screening in Denmark
Low Levels of PAPP-A– Trisomy 21– Other chromosome abnormalities
Trisomy 18 Trisomy 13
– Aneuploidy– Impending fetal death– Impaired fetal wellbeing
Preterm labour Low birth weight
Borås, May 11th, 2007page 61
First trimester screening in Denmark
Free -subunit hCG
– Glycoprotein hormone– Secreted by placental trophoblast subunit derived by elastase activity on total
HCG– Detectable 10 days post ovulation– Initially doubles every 1.5 – 2 days– Peaks at 8-10 weeks (FTS performed at 10-14
weeks)– Increased levels in Downs (2.0 -2.5 MoM)
Borås, May 11th, 2007page 62
First trimester screening in Denmark
MoM (analyte A) =Measured concentration of A
Median concentration of A at gest.age
__________________________________
MoMs are independent of gestational age
and concentration units
MoM ~ ”fraction of normal”
Multiples of median MoMs
Borås, May 11th, 2007page 63
First trimester screening in Denmark
-hCG
AB
C
D
A B
C
D
Total HCG
Alpha Subunit
Beta Subunit
Borås, May 11th, 2007page 64
First trimester screening in Denmark
LogMoM values are used in calculations
as they exhibit a Gaussian distribution
Barnes, 2005
Borås, May 11th, 2007page 65
First trimester screening in Denmark
Factors influencing marker performance
– Maternal weight– Smoking– Diabetes mellitus– Twins– Ethnicity– Mode of conception– Parity
Borås, May 11th, 2007page 66
First trimester screening in Denmark
Bivariate Risk Calculation
f x y
x y x y
x y
x
x
y
y
x
x
y
y
( , )
exp .
1
2 1
1
12
2
2
2 2
H Cuckle
Borås, May 11th, 2007page 67
First trimester screening in Denmark
Implementation of 1. trimester screening NT + biochemistry
The sonography follows FMF guidelines– NT performed at centers with trained
sonographers and doctors Major Departments of Fetal medicine performing the
NT had all been trained by the Fetal Medicine Foundattion, London, all sonographers were already FMF-certified.
– Software All Departments of Fetal medicine were using the
Astraia software. (All FMF approved)
– NT QC All sonographers are FMF certified
Borås, May 11th, 2007page 68
First trimester screening in Denmark
The challanges
– Pre-analytical– Astraia
The window for which biochemistry is accepted in Astraia
Inability of Astraia to communicate with the Hospital Laboratory Information Management System
Medians
Borås, May 11th, 2007page 69
First trimester screening in Denmark
The biochemists 10 wishes
1. Reproducibility of values over time (no drift)2. Reproducibility of values over time (no drift)3. Reproducibility of values over time (no drift)4. Reproducibility of values over time (no drift)5. Reproducibility of values over time (no drift)6. Reproducibility of values over time (no drift)7. Precision8. Robustness9. High specificity – no interference10.Documentation
Borås, May 11th, 2007page 70
First trimester screening in Denmark
Number of women not enroling in the first trimester screening: 6% - 8%
Reasons• Late bookers • Ethnic minorities • Unaware of the screening program• Don’t wish to be screened (few)
K Sundberg, unpublished data
Reasons for not enroling in the first trimester screening
Borås, May 11th, 2007page 71
First trimester screening in Denmark
Transport of blood samples to the laboratories – unexpected help from the Royal Danish Mail
Most counties in Denmark are currently implementing systems where the samples will be picked up at the GPs
(This is not because the National Health Care wants to reduced the pre-analytical errors but because they can save money – sending blood samples by mail has become too expensive).
Borås, May 11th, 2007page 72
First trimester screening in Denmark
How to handle the changes in the medians
– The Astraia database generates a new set of medians from data collected in it. Fourthermore there is a mimgenererer nye medianer baseret på de data som er indtastet i Astraia databasen ud fra de krav vi har opstillet (f.eks 200 pr. uge i de forudgående 6 måneder. Det vil gøre det umuligt at dele medianer mellem 2 centre fordi medianen udelukkende kan genereres ud fra data i den enkelte database.
– At Astraia genererer medianer ud fra indtastede medianer, som et var i den gamle version. Dvs. at man blot indtaster en medianværdi for hver enkelt gestationsuge 8+3, 9+3, 10+3 etc. Og at Astraia så selv genererer den nye median. Det er et ”åbent system” hvor der ikke er krav til datamængde, og hvor medianer kan deles mellem centre. Og hvor det også vil være muligt at generere DPC Immulite medianer hvis det er det som man har lyst til!!
– Data is sent to London (Kevin) or Germany (Roland). From these data they generate a new set of medians.
– Probelms FMF has the rights to the risk module in Astraia. What will they accept.