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Published on: September 16, 2012
V-PRO Blood Collection Tubes: Validation for Clinical Chemistry and Immunoassay Tests
Anwar Borai1, Wedyan Alsharif1, Amirah Alhindi1
1King Abdullah International Medical Research Center (KAIMRC), King Saud bin Abdulaziz University for Health Sciences (KSAU-HS), King Abdulaziz Medical City, Ministry of National Guard, Jeddah, Saudi Arabia.
New V-PRO blood collection tubes show significant biases in key chemistry and immunoassay tests compared to BD Vacutainers. Technical validation revealed unacceptable pre-analytical, analytical, and post-analytical errors, questioning V-PRO tube suitability for clinical diagnostics.
Area of Science:
- Clinical diagnostics
- Laboratory medicine
- Medical device validation
Background:
- Diagnostic product components require validation before routine patient testing.
- BD Vacutainers are standard blood collection tubes; V-PRO tubes are new without prior validation.
- This study validates V-PRO tubes against BD Vacutainers for clinical laboratory use.
Purpose of the Study:
- To compare the performance of V-PRO tubes against BD Vacutainers.
- To assess the validity of V-PRO tubes for routine blood testing.
- To identify potential biases and errors associated with V-PRO tube usage.
Main Methods:
- Simultaneous blood collection from 60 subjects into V-PRO and BD tubes.
- Analysis of 28 chemistry tests, 20 immunoassays, and glycated hemoglobin.
- Evaluation of biases against quality specifications and technical validation surveys.
Main Results:
- V-PRO tubes showed biases exceeding limits for CO2, magnesium, TSH, and estradiol.
- Higher rates of pre-analytical, analytical, and post-analytical errors were reported for V-PRO tubes.
- Technical validation indicated significant faults in V-PRO tubes compared to BD Vacutainers.
Conclusions:
- Caution is advised for laboratories considering V-PRO tubes for chemistry and immunoassay testing.
- V-PRO tubes demonstrated unacceptable technical validation outcomes.
- BD Vacutainers remain the preferred choice due to V-PRO tube's identified limitations.
