Et viktig fremskritt for diagnostikk av hjerteinfarkt

Hurtighet og nøyaktighet når hvert sekund teller - ventetiden er over for høysensitiv troponin pasientnært

Når en pasient ankommer akuttmottaket med symptomer på hjerteinfarkt er tiden kritisk. Hvert minutt brukt på å vente på testresultater har en kostnad. Pasienter og deres familier er engstelige, og klinikere og laboratoriepersonell jobber under tidspress for å gi en rask og nøyaktig diagnose. Lange svartider kan overbelaste akuttmottaket. Så hva om akuttmottaket hadde tilgang til å måle høysensitiv troponin pasientnært? Med kun et lite stikk i fingeren gir immunkjemi instrumentet Atellica VTLi høysensitive troponin I resultater (hs-cTnI) på kun 8 minutter. Å kunne få svar på pasientens troponin verdi raskt og der pasienten er, betyr at legen er ved pasientens side når svaret foreligger. Dette hjelper helsepersonell med å diagnostisere og behandle hjertepasienter enda raskere.

Bestemmelse av de kjønnsspesifikke 99 persentilene for Siemens Healthineers sin høysensitive og pasientnære troponin analyse Atellica VTLi hs-cTnI ved bruk av heparinplasma fra AACC sin universale biobank. Studien ble opprinnelig publisert i Clinical Chemistry og Laboratory Medicine.

Dr. Fred Apple

"Det pasientnære instrumentet Atellica VTLi fra Siemens Healthineers gir høysensitve troponin I svar fra fullblod på kun 8 minutter. Prøveresultatene er sammenlignbare med troponin resultatene man får fra medisinske laboratorier. Jeg tror dette instrumentet enkelt kan integreres i eksisterende arbeidsflyt på sykehus og klinikker, med potensiale til å påvirke pasientbehandlingen, samt kliniske- og økonomiske resultater, i positiv retning."

Dr. Fred Apple, PhD, medisinsk direktør for kliniske laboratorier, klinisk kjemi, pasientnær analysering, klinisk- og rettsmedisinsk laboratorium, Hennepin County Medical Center

Population

99th URL (ng/L)

Timepoint

Subjects

Sensitivity
(95% CI)

Specificity
(95% CI)

PPV
(95% CI)

NPV
(95% CI)

Non-MI

MI

Overall

22.9

Baseline

998

91

64.8%
(54.6–73.9%)

85.7%
(83.4–87.7%)

29.2%
(25.0–33.8%)

96.4%
(95.3–97.2%)

2 hrs

998

91

81.3%
(72.1–88.0%)

84.6%
(82.2–86.7%)

32.5%
(28.7–36.4%)

98.0%
(97.0–98.7%)

Male

27.1

Baseline

615

56

67.9%
(54.8–78.6%)

86.2%
(83.2–88.7%)

30.9%
(25.5–36.9%)

96.7%
(95.3–97.7%)

2 hrs

615

56

80.4%
(68.2–88.7%)

84.7%
(81.7–87.3%)

32.4%
(27.6–37.5%)

97.9%
(96.5–98.8%)

Female

18.5

Baseline

383

35

65.7%
(49.2–79.2%)

85.4%
(81.5–88.6%)

29.1%
(22.6–36.6%)

96.5%
(94.5–97.7%)

2 hrs

383

35

82.9%
(67.3–91.9%)

84.3%
(80.4–87.6%)

32.6%
(26.8–38.9%)

98.2%
(96.3–99.1%)

Streamlined Patient Testing Workflow

Clinical value of high-sensitivity hs-cTnI

Cartridge Design

Troponin:
High-Sensitivity vs. Contemporary

  1. Operator scans ID

    Operator scans ID

    • Sample type flexibility: The system can produce results on lithium-heparin whole blood, lithium-heparin plasma, and capillary samples.
    • Sample volume: minimum of 30 µL of blood required to perform the test.
    • Test results are sent securely through our POC Ecosystem™ Solution via WI-FI or Ethernet for storage in the LIS/HIS and EMR.

  2. Atellica VTLi Test resutls

    Compared with conventional troponin assays:

    • Higher NPV for AMI
    • Reduced “troponin-blind” interval, leading to earlier detection of AMI
    • Result in ~4% absolute and ~20% relative increases in the detection of type 1 MI and corresponding decrease in the diagnosis of unstable angina
    • Associated with 2-fold increase in the detection of type 2 MI

    Levels of hs-cTn are quantitative markers of cardiomyocyte damage:​

    • Elevations greater than 5 times the URL have high (90%) PPV for acute type 1 MI.​
    • Elevations up to 3 times the URL have limited (50–60%) PPV for AMI.​
    • It is common to detect circulating levels of cardiac troponin in healthy people.

    Rising and/or falling cardiac troponin levels differentiate acute from chronic cardiomyocyte damage.

  3. Reagent cartridge top view

    Reagent cartridge top view

    The cartridge is disposable (single-use) and specific for one or more assays, with no warm-up time from refrigerated storage.

    Each disposable cartridge is identified by a unique Radio Frequency identification (RFID) chip, that contains information on the type of test, calibration data, and lot-specific information.

    • Instructs the instrument to automatically starts the correct assay protocol
    • Integrated assay quality control in every cartridge

  4. NDA Atellica Cardiac Chart
    • Contemporary assays must detect cTn in 20% to <50% of healthy individuals.
    • High-sensitivity assays must detect cTn in at least 50% of healthy individuals and must have <10% CV at the 99th percentile of normal.
    • Units of measure:
      • Contemporary: ng/mL
      • High-sensitivity: ng/L

Screenshot of the self test on analyzer

Test Utilization

  • Software version/validity
  • Electronic system
  • Temperature control system
  • Storage space
  • Imaging system
  • Analyzer orientation
  • Battery level
  • Magnetic system  

POC Atellica VTLi Cartridge

Cartridge Validation

  • RFID version/validity
  • Cartridge use data
  • Light intensity reference
  • Cartridge type
  • Cartridge alignment
  • No sample added
  • Expiry date
  • Optical image quality 

POC Atellica VTLi Dispensing Blood Capillary

Sample Application

  • Sample application
  • Cartridge filling time
  • Sample volume check 

Test results are available within 8 minutes after sample application.

Test Execution

  • Analyzer cap closed
  • Cartridge temperature
  • Dynamic readout
  • Power button disabled
  • Light intensity
  • Cartridge movement
  • Analyzer orientation/shock  

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