Validering og kvalitetssikring af ny hjemmetest - Point of care TSH-test

  • Høgdall, Dan (Projektleder)
  • Smith, Julie (Projektleder)
  • Nielsen, Leif Kofoed (Projektleder)
  • Jørgensen, Søren Frank (Projektleder)
  • Bonnema, Steen (Projektdeltager)
  • Svendsen, Winnie (Projektleder)

    Projekter: ProjektForskning

    Projektdetaljer

    Beskrivelse

    Background: To ensure that the new developed Point of care TSH device can be used in clinical settings, we need to provide data about device performance in terms of validity, reproducibility, accuracy and precision. These data will further contribute to for future regulatory approval. The work will be guided by the recommendation for method validation from Danish Society for Clinical Biochemistry. The first task will focus on validating the sensor surface.
    Aim: Validate sensor precision performance to measure TSH in plasma by correlation with standard lab measurements.
    Method:
    1. Samples with TSH measurements in the clinical relevant plasma range of 0.1-10.0 IU/ml will be collected from Odense University Hospital (OUH). Accuracy and precision of our device will be compared with the validated immunoassay method used at OUH the currently used golden standard and the aim is having non-inferior variation using patient samples. Linearity in our claimed measuring range will be investigated using a known low TSH pool of patient samples spiked with known TSH concentrations into the desired spectrum of ranges between 0.1-10.0 IU/ml. Precision will be validated by repeated measures in different ranges of concentration between 0.1-10.0 IU/ml using both patient samples and spiked samples. Limit of detection together with upper concentration for hook effect will be elucidated. Further, device validity will be pursued by examining the effect of known cross-reactive substances (FSH, LH and hcg) and their interference on device TSH measurements will be reported.
    Outcome: This task will provide needed data on sensor precision performance, which is needed for further clinical testing.

    2. Heparinized whole-blood from a patient with known low TSH will be collected and spiked with TSH until a concentration range in our claimed detection range is obtained. Samples will be measured in triplicates to investigate inter- and intra-sample variability. Further, samples with a variable haematocrit and known cell counts will be included to investigate potential variability in the sample handling unit, when correlated with cell counts.

    Outcome: This task will indicate if the integration of sample handing and sensor surface can be use by patients to measure TSH in capillary blood.

    Kort titelAfprøvning af ny TSH-hjemmetest
    StatusIgangværende
    Effektiv start/slut dato01/01/22 → …