NIH, National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) NIH - National Institutes of Health National Cancer Institute DCTD - Division of Cancer Treatment and Diagnosis

Validation of low-volume blood collection tubes for routine hematologic testing.

Author(s): Lippi G, Martini L, Cortivo B, Zecchetto C, Ferrari A

Publication: J Med Biochem, 2024, Vol. 43, Page 955-959

PubMed ID: 39876916 PubMed Review Paper? No

Purpose of Paper

This paper explored the effects of blood collection tube choice and underfilling on complete blood count (CBC) using case-matched specimens collected from healthy volunteers. Blood cell counts of properly filled 3.0 mL Vacutest K2EDTA tubes, 3.0 mL Vacutest K2EDTA tubes filled with 0.5 mL blood, and properly filled 0.5 mL MiniCollect Complete Greiner low-volume tubes were compared with a hematology analyzer.

Conclusion of Paper

Filling a 3.0 mL K2EDTA tube with 0.5 mL instead of 3.0 mL blood resulted in lower median white blood cell (WBC, P<0.05), neutrophil (P<0.05),  lymphocyte (P<0.05) and platelet (P<0.01) counts; lower mean corpuscular hemoglobin concentration (MCHC, P<0.01); and higher median red blood cell (RBC) count (P<0.01), hemoglobin (P<0.01), hematocrit (P<0.01), mean corpuscular volume (MCV, P<0.01), and mean platelet volume (MPV, P<0.05); however, only the increase in hematocrit (3.8%) and mean corpuscular volume (MCV, 2.4%) and decrease in MCHC (-2.6%) exceeded the desired bias.  Blood in low-volume tubes had lower median WBC (P<0.01), neutrophil (P<0.05), lymphocyte (P<0.01), and platelet (P<0.01) counts; lower MCV (P<0.05); and higher median RBC count (P<0.01), hemoglobin (P<0.01), hematocrit (P<0.05), MCHC (P<0.05), and MPV (P<0.01); however, none of the changes were considered clinically significant, as they remained within the desired bias.

Studies

  1. Study Purpose

    This study explored the effects of blood collection tube choice and underfilling on complete blood count (CBC) using case-matched specimens collected from healthy volunteers. Blood cell counts of properly filled 3.0 mL Vacutest K2EDTA tubes, 3.0 mL Vacutest K2EDTA tubes filled with 0.5 mL blood, and properly filled 0.5 mL MiniCollect Complete Greiner low-volume tubes were compared with a hematology analyzer. Blood was collected into a 5 mL syringe using a 21-gauge butterfly needle from 44 healthy volunteers. From each sample, 3 mL of blood was transferred into a 3.0 mL Vacutest K2EDTA tube,and 0.5 mL of blood was transferred into both a 3.0 mL K2EDTA tube and a 0.5 mL MiniCollect Complete Greiner low volume tube.  Blood was mixed by 4-6 inversions and CBCs were performed on a Sysmex XN-10 hematology analyzer. The maximum desirable bias was calculated based on intra- and inter-individual variation.

    Summary of Findings:

    Filling of a 3.0 mL K2EDTA tube with 0.5 mL instead of 3.0 mL blood resulted in lower median WBC (P<0.05), neutrophil (P<0.05),  lymphocyte (P<0.05) and platelet (P<0.01) counts; lower MCHC (P<0.01); and higher median RBC count (P<0.01), hemoglobin (P<0.01), hematocrit (P<0.01), MCV (P<0.01) and MPV (P<0.05); however, only the increase in hematocrit (3.8%) and MCV (2.4%) and decrease in MCHC exceeded the desirable bias.  Blood in low-volume tubes had lower median WBC (P<0.01), neutrophil (P<0.05),  lymphocyte (P<0.01) and platelet (P<0.01) counts; lower MCV (P<0.05); and higher median RBC count (P<0.01), hemoglobin (P<0.01), hematocrit (P<0.05), MCHC (P<0.05) and MPV (P<0.01); however, none of the changes were considered clinically significant, as they remained within the desire bias.

    Biospecimens
    Preservative Types
    • Frozen
    Diagnoses:
    • Normal
    Platform:
    AnalyteTechnology Platform
    Cell count/volume Hematology/ auto analyzer
    Protein Hematology/ auto analyzer
    Pre-analytical Factors:
    ClassificationPre-analytical FactorValue(s)
    Biospecimen Acquisition Type of collection container/solution 0.5 mL MiniCollect Complete Greiner low volume tube
    3.0 mL Vacutest K2EDTA tube
    Biospecimen Aliquots and Components Aliquot size/volume 0.5 mL in 0.5 mL MiniCollect Complete Greiner low-volume tube
    0.5 mL in a 3.0 mL Vacutest K2EDTA tube
    3.0 mL in a 3.0 mL Vacutest K2EDTA tube

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