What went wrong in Gothenburg? - Start | Equalis went wrong in gothenburg_s... · Sysmex test...
Transcript of What went wrong in Gothenburg? - Start | Equalis went wrong in gothenburg_s... · Sysmex test...
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What went wrong in Gothenburg?or
Why is it so hard to count platelets…
Stefan Jacobsson
överläkareKlinisk kemi, Sahlgrenska Universitetssjukhuset
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…because they are so peculiar!
JCB9909028.V1.mov
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Identification and quantification of intermediates in platelet release by immunofluorescence
microscopy.
Thon J N et al. J Cell Biol 2010;191:861-874
© 2010 Thon et al.
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Direct visualization of proplatelet/platelet release in culture.
Thon J N et al. J Cell Biol 2010;191:861-874
© 2010 Thon et al.
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Organization of the cytoskeleton in the mature platelet and proplatelet.
Hartwig J et al. J Thromb Haemost 2003;1:1580-1586© 2003 Hartwig et al.
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Bending and branching of mouse proplatelets.
Hartwig J et al. J Thromb Haemost 2003;1:1580-1586© 2003 Hartwig et al.
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α-Granule delivery to the proplatelet tip.
Hartwig J et al. J Thromb Haemost 2003;1:1580-1586© 2003 Hartwig et al.
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Even more strange in the disease state…
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Platelets are so diverse…
• In the blood:
– Differ already as newborns
– Of different age
– Of different fate
• In the sample:
– Swell
– Partially activated
Heterogenous:
Size, form, content
Measuring characteristics
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So we should validate the platelet counting
performance with normal and pathological platelets
”Procedur för validering vid byte av metod, analys kit,
instrument etc” Id:AX0197 (Utför relevanta avsnitt).Datum
(utförande)
Bilaga nr Sign
Om resultaten inte finns som kopplade godkända pdf dokument i RMT+ så skall de skannas
och pdf kopplas till detta dokument
Selektivitet/specificitet
Arbetsområde (tekniskt intervall)
Interferenser
Carry over (smitta mellan prover/ mellan reagens)
Linearitet
Detektionsgräns/kvantiteringsgräns
Utbyte
Jämförelse patientprover
Inomserie variation *
Total variation *
Referensintervall (byte av) *
Backup (reserv) metod/instrument
2. Validering av metod
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OptSapph vs ADVIA, PLT, SU
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OptSapph vs ADVIA, PLT, ÖS
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OptSapph vs ADVIA, low PLT, SU
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OptSapph vs ADVIA, low PLT, SU
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OptSapph vs ADVIA, low PLT, SU
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OptSapph vs ADVIA, low PLT, ÖS
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OptSapph vs ADVIA, low PLT
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ImmCD61 vs ADVIA, low PLT
0
2
4
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10
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14
16
18
1 2 3 4
CD61
Optik S
Optik A
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ADVIA vs ADVIA, PLT
Analys diff i enheter mot ref. instr.
Välj referensinstrument eller mv från listan
-60,00
-40,00
-20,00
0,00
20,00
40,00
60,00
150,0 200,0 250,0 300,0 350,0 400,0 450,0
Analys och enhet
Anal
ys
diff
i en
hete
r
M1190 MIKROS S3609 S3611 S3612
Ö2701 Ö2702
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ADVIA vs ADVIA, PLT
TPK diff i enheter mot ref. instr.
Välj referensinstrument eller mv från listan
-40,00
-30,00
-20,00
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0,00
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20,00
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50 100 150 200 250 300 350 400
TPK 10E9/L
TP
K
dif
f i en
het
er
M1190
MIKROS
S3611
S3612
Ö2701
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Carry over, PLT
Sysmex test XT-200i Operator's Guide
(L1 - L3) / (H3 - L3) (L1 - L3) / H1
H1 H2 H3 L1 L2 L3 % Carry over % Carry over
1045 1008 1039 12 13 14 -0,195% -0,191%
971 959 950 14 13 9 0,531% 0,515%
1063 1062 1059 16 7 8 0,761% 0,753%
876 877 881 21 18 18 0,348% 0,342%
697 702 685 21 19 15 0,896% 0,861%
542 547 531 11 10 10 0,192% 0,185%
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What we found, in short…
• Positive bias
• Significant carry over
• Difficulties in harmonizing instruments
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How did Siemens explain all this
• Manufacturing flaws
• Installation adjustments suboptimal
• Calibration suboptimal
• Calibrator bias
– Reference method deviations
• Optical alignment material malfunctioning
• Method adjustments necessary
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Platelet count – yearly mean values
Preliminary results for 2010
-6
-4
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0
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2005 2006 2007 2008 2009 2010
Me
an y
ear
ly d
evi
atio
n (%
) fro
m s
urv
ey
me
an
ADVIA 120 ADVIA 2120 ADVIA 2120i
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Kalibrering, specifikation
Alla tilldelade värden för ADVIA SETpoint Hematology-kalibrator och ADVIA TESTpoint
Hematology-kontroller är baserade på NISTs, ICSHs eller NCCLSs rekommenderade
procedurer eller godkända referensprocedurer och material.
...
Referensräkningen för PLT utförs med hemocytometer och faskontrastmikroskop. Makro-
spädningen för PLT är 1:125 med 1 % ammoniumoxalat som spädningsvätska.
De systemspecifika värdena (SSV) har tilldelats för ADVIA 120 SETpoint Hematology-
kalibrator- och ADVIA 120 TESTpoint Hematologykontroll-produkterna genom att
analysera varje lotnummer i ett ADVIA 2120/2120i Hematology-system som kalibrerades
med färska, normala helblodsprov som tilldelats värdena RBC, WBC, PLT, HCT och
HGB med hjälp av den metod som beskrivs ovan.
ADVIA 120 OPTIpoint-värdena tilldelas med ett ADVIA 2120/2120i Hematology-system
efter att systemet har standardiserats med tre referensoljor.
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Carry over, specifikation
Prestandaegenskaper: Carryover
Prov-carryover för ADVIA 120 Hematology-systemet uppmättes för WBC, RBC, HGB och
PLT. Prestandaspecifikationen för carryover är ≤1% för samtliga parametrar.
Carryover utvärderades i ADVIA 120 Hematology-systemet genom aspirering av en hög
pool förberedd för linjär testning, följt av 3 aspirationer av cellfri plasma.
Procentuell carryover beräknades som:
% carryover = [(L1 - L3) / H] x 100
L1 = räkningen för den första aspirationen av cellfri plasma
L3 = räkningen för den tredje aspirationen av cellfri plasma
H = räkningen från den höga poolen
Följande resultat erhölls:
Parameter Observerad carryover
WBC 0,4 %
RBC 0,2 %
HGB 0,2 %
PLT 0,1 %
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Ongoing workMPV, PDV, pathological samples…
-2
-1,5
-1
-0,5
0
0,5
1
6,00 6,50 7,00 7,50 8,00 8,50 9,00 9,50 10,00
MPV (mv)
Dif
fere
ns C
elld
yn
- A
DV
IA
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Thank You for listening!
And thanks to all my coworkers at:
Sahlgrenska Universitetssjukhuset
SÄS, NÄL, Kungälvs sjukhus
Stefan Jacobsson