V-PRO Blood Collection Tubes: Validation for Clinical Chemistry and Immunoassay Tests.

Abstract

Background: In accredited laboratories, each component of diagnostic products-such as laboratory instruments, reagents, and blood collection tubes must be validated before integration into routine patient testing. BD Vacutainers are commonly used in clinical laboratories compared to other blood collection tubes, while V-PRO tubes have recently been introduced to the market without prior laboratory validation. This study compares V-PRO tubes to BD Vacutainers to assess the validity of using V-PRO tubes for blood testing.

Materials and methods: Blood samples were collected simultaneously into two different brands of tubes (V-PRO and BD) from 60 subjects. A standardized procedure was employed for sample collection, and analysis. A total of 28 chemistry tests and 20 immunoassays were analyzed using Abbott instruments, while high-performance liquid chromatography was used for testing glycated hemoglobin. The biases of V-PRO compared to BD were evaluated against current desirable quality specifications for bias derived from biological variation. For technical validation, a designated survey was distributed to various institutes using both tube types in their laboratories.

Results: The V-PRO tube exhibited biases exceeding the desirable limits for CO₂ (3.2%), magnesium (2.0%), thyroid-stimulating hormone (11.7%), and estradiol (-8.5%). Survey results indicated a higher percentage of major pre-analytical, analytical, and post-analytical errors when using the V-PRO tube compared to the BD Vacutainer.

Conclusions: Laboratories currently using BD vacutainers should exercise caution if they intend to perform chemistry and immunoassay tests with V-PRO tubes. The technical validation outcomes for V-PRO were not acceptable due to significant faults identified in comparison to BD Vacutainer.