Et vigtigt fremskridt for diagnose af hjerteinfarkt

Hastighed og nøjagtighed når hvert sekund tæller med analysering af højsensitiv troponin som point of care

Når liv er på spil, og hvert sekund er afgørende, hvordan kan klinikere så hurtigt få de svar, de har brug for? Hvert tabt sekund i akutmodtagelsen kan potentielt påvirke patientforløbet. Atellica® VTLi point of care Immunkemi instrumentet giver den vitale information, klinikere har brug for for at hjælpe med at træffe hurtige beslutninger.

Når man udelukker et potentielt myokardieinfarkt (MI), har hvert minut, der bruges på at vente på testresultater, en pris, men hvad nu hvis personalet i akutmodtagelsen havde adgang til højfølsom troponin som point of care? Overvej værdien af at tilføje et nyt værktøj til klinikerens rådighed, som kan give højfølsomme troponin I (hs-cTnI) resultater på kun 8 minutter ud fra et enkelt fingerprik. At kunne få et hurtigt svar straks ved patientens side betyder, at lægen er til stede når svaret foreligger. Dette betyder endnu hurtigere diagnose og behandling for hjertepatienter. 

Bestemmelse af kønsspecifikke 99. percentil øvre referencegrænser fofor Siemens Healthineers højsensitive POC troponin analyse Atellica® VTLi hs-cTnI ved brug af heparin plasma fra AACC universale biobank. Studiet er oprindeligt publiceret i Clinical Chemistry and Laboratory Medicine (maj 2021) med tilladelse til publicering af De Gruyter.

Dr. Fred Apple

”Det patientnære instrument Atellica VTLi fra Siemens Healthineers giver højsensitive troponin I svar fra fuldblod på kun 8 minutter. Prøveresultatene er sammenlignelige med troponin resultatene fra laboratoriet. Jeg tror, at dette instrument nemt kan integreres i det eksisterende arbejdsflow på hospitalerne og har potentiale til at påvirke patientbehandlingen, samt kliniske- og økonomiske resultater, i positiv retning."

Dr. Fred Apple, PhD, Medical Director of clinical laboratories, clinical chemistry, point-of-care testing, and clinical and forensic toxicology laboratories på 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 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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