1

Troponina T ad alta sensibilità

16 dicembre 2010/10 gennaio 201131 gennaio 2011 Cesena

1 febbraio 2011 Rimini 7 febbraio 2011 Forlì

2

• È necessario che il laboratorio ed i reparti clinici trovino un accordo su quali cut-off sia meglio adottare

• I dosaggi ad alta sensibilità delle troponinecardiache I e T mostrano una migliore sensibilità analitica e clinica rispetto ai vecchi metodi meno sensibili.

• Questo incremento di sensibilità permetteràdi evidenziare più precocemente una necrosi cardiaca rispetto al passato.

3

• Circa la metà dei pazienti con sospetta sindrome coronarica acuta e Tn hs aumentate potrebbero avere patologie cardiache acute non causate da SCA.

• Misure seriate (entro le 3-6 ore) delle Tn utili a distinguere tra SCA e altre patologie acute non-ischemiche.

4

I professionisti suggeriscono

cautela

5

6

7

Le Aziende di diagnostici sono partiteLe aziende

sanitarie sono partite

8

9

10

11

12

13

0.03 g/L Tropo T =

50 ng/l Tropo T hs

14

15

AVRAVR

16

17

18

19

rule outrule out

20

rule inrule in

21

MementoMemento

22

Rimangono le

troponinosi

Rimangono le

troponinosi

23

24

Mean age 44±13.8 yearsMean age 44±13.8 years

25

26

27

The Roche Elecsys high sensitive troponin T (hsTnT) assay meets theseperformance criteria (10% CV is at 13 ng/L, the 99°percentile is 14 ng/L) and isnow being introduced in laboratoriesthroughout the world.

in June in Manchester Clinical Biochemists and Roche

28

the reporting units should be ng/Lresults reported down to 3 ng/Ltwo measurements required2° sample: 6-9 hours after presentationif the 2°sample not an incrementalrise, yet clinical suspicion, a furthersample at 12 hours.

in June in Manchester Clinical Biochemists and Roche

29

a: Less than 20% change: notconsistent with an acute eventb: 20-100% change: suggestfurther evaluationc: Greater than 100% change: consistent with myocardialinfarction.

in summer in Cardiff Clinical Biochemists and Roche

30

Patients with hsTnT chronically >14 ng/Lare at risk of future cardiac eventsNo conclusion was reached on whatsingle level of hsTnT could be used todiagnose an MIIt is recognised that as evidenceaccumulates, practices may changeaccordingly. A consensus approach is preferableto multiple local practices.

in June in Manchester Clinical Biochemists and Roche

31

32

33

Results reported in ng/L

Results from the hs-TnT assay will bereported in ng/L rather than the previously used ug/L. This producesnumber which are 1000 times higherand all results will be in wholenumbers. For example a result of 0.015 ug/L becomes 15 ng/L. This willreduce reading and transcriptionerrors.

34

New Reference Interval:0-14 ng/LResults of 15 ng/L and above are considered elevated.It is estimated that here will bemore 2-3 times patients withelevated troponinMany of these will have conditionsother than ACS

35

AMIPatients with a good history for AMI and Troponin T >100 ng/L can be diagnosed with a single Tn resultA delta troponin >30% within3 – 12 hours together with at leastone Tn hs supportive of AMI.A stable troponin elevation (delta less than 30%) is more likely in other diagnoses.

36

37

38

39

• 1.Units: It was agreed that the reportingunits for hs-cTnT should be ng/L

• 2.Reporting Limits: The consensus wasthat results should be reported down tothe limit of the blank (LOB) that is 3 ng/L.

• 3. It was agreed that 14 ng/L, the 99th percentile of hs-cTnT in healthyindividuals should be employed as the upper reference limit (URL).

40

Reference population study included616 apparently healthy volunteers and blood donors aged between 20 and 71 years. Exclusion criteria applied to the

healthy volunteers were diabetes, renal impairment, coronary arterial

disease, and cardiac structuralabnormalities (Echocardiogram

assessed).

Professor Giannitsis

41

It was agreed that• 4. Clinical Significance this new hs-

cTnT assay will enable more rapiddiagnosis of MI but will also increasethe detection frequency of Tnelevations not due to ACS

• 5. Serial Measurements at least twomeasurements of hs-cTnT are essential to satisfy the UDMI. The first sample to be collected on presentationand the second, 6 hours later.

42

• In an evolving MI, hs-cTnT wouldbe expected to rise above >14 ng/L within the first 6 hrs after presentation with a delta changeof at least 100%

• A delta change of <20% within6 hrs was not consistent with anacute event.

It was agreed that

43

8. Report CommentsIt was suggested that

interpretative comments thataccompany hs-cTnT resultsshould be harmonised. Time

constraints did not allowconsensus to be reached

44

45

Laboratorians in Norwayhave recommended not using the 99th

percentile as the cutoff for MI, but rather a higher level of 0.03 µg/L. “This is to avoidover-diagnosis of MI, a particular concern

in elderly patients, many of whom will havenormal values higher than 14 ng/L

circulating,” explained Omland.

46

Of importance, a negative sensitive troponin test will havea high negative predictivevalue, and may thus serve asan exclusionary test early in the diagnostic process.

47

As multiple conditions are associated with Tn elevation, pretest likelihood of disease, clinical presentation and serial testing will become increasinglyimportant for identifying thosepatients with true acute coronarysyndromes

48

According to the hs-cTnT assay, all of the ESRD patients hadelevated cTnT concentrations at least once during the follow-up.

49

50

51

Ecco la ns

proposta di

referto

Ecco la ns

proposta di

referto

52

53

54

55

56

57

58

59

60