Finger Prick blood collection validation studies

Recruiting

• Conditions: Covid-19 serology; general clinical chemistry; HbA1C; IVD Diagnostic tests: PSA; 10047438; 10018424; 10038597

• Registration Number: NL-OMON51204
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 480

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

N.A.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>- To determine whether the finger prick blood collection system procedure can<br /><br>reliably replace venepuncture blood collection for the PSA, Covid-19 serology,<br /><br>HbA1c and routine clinical chemistry testing.<br /><br><br /><br>Validation requirements:<br /><br>- Correlation coefficient (Spearmans) of finger prick with venipuncture serum<br /><br>is > 0,90.<br /><br>- Regression analysis: 95% CI of slope includes 1.00<br /><br>- Less than 5% outliers (recovery < 70% or > 130%)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Finger prick blood collection procedure performed by patients or healthy<br /><br>volunteers is feasible: > 80% of finger prick blood collection procedures<br /><br>performed results in a suitable sample for analysis.</p><br>