Finger Prick blood collection validation studies

Finger Prick blood collection validation studies - Finger Prick blood collection validation studies

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51204

Enrollment

360

Registered

2021-06-18

Start date

2021-09-13

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19 serology general clinical chemistry HbA1C IVD Diagnostic tests: PSA

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: 120x PSA requirest at blood collection facility 120x HbA1c request at blood collection facility Healthy volunteers: 120X Proven Covid-19 infection health care professional 120X Partner of NKI patient (without Cancer)

Exclusion criteria

Exclusion criteria: N.A.

Design outcomes

Primary

Measure	Time frame
Primary Objective: - To determine whether the finger prick blood collection system procedure can reliably replace venepuncture blood collection for the PSA, Covid-19 serology, HbA1c and routine clinical chemistry testing. Validation requirements: - Correlation coefficient (Spearmans) of finger prick with venipuncture serum is > 0,90. - Regression analysis: 95% CI of slope includes 1.00 - Less than 5% outliers (recovery 130%)	—

Measure

Time frame

Primary Objective: - To determine whether the finger prick blood collection system procedure can reliably replace venepuncture blood collection for the PSA, Covid-19 serology, HbA1c and routine clinical chemistry testing. Validation requirements: - Correlation coefficient (Spearmans) of finger prick with venipuncture serum is > 0,90. - Regression analysis: 95% CI of slope includes 1.00 - Less than 5% outliers (recovery 130%)

—

Secondary

Measure	Time frame
- Finger prick blood collection procedure performed by patients or healthy volunteers is feasible: > 80% of finger prick blood collection procedures performed results in a suitable sample for analysis.	—

Countries

Netherlands

Outcome results