Applied research on micro blood collection tubes in clinical coagulation testing
Original Article

Applied research on micro blood collection tubes in clinical coagulation testing

Meifang Lin1#, Miaoshan Luo2#, Kuncheng Wang3, Dongdong Li3, Yun Zhou1, Jing Yang1, Minhong Wang1, Zhongying Wang1, Qiang Zhou1

1Department of Clinical Laboratory, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, China; 2Guangzhou Medical University, Guangzhou, China; 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China

Contributions: (I) Conception and design: M Lin; (II) Administrative support: Q Zhou; (III) Provision of study materials or patients: M Luo, K Wang, D Li; (IV) Collection and assembly of data: Y Zhou, J Yang, M Wang; (V) Data analysis and interpretation: Z Wang, Q Zhou; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

#These authors contributed equally to this work as co-first authors.

Correspondence to: Qiang Zhou, PhD. Department of Clinical Laboratory, The Second Affiliated Hospital, Guangzhou Medical University, No. 250 Changgang East Road, Haizhu District, Guangzhou 510260, China. Email: 2008690871@gzhmu.edu.cn.

Background: Vacuum blood collection tubes are essential for clinical testing, but traditional tubes have a number of limitations. Microtubes are increasingly being used to reduce required blood volumes and patient discomfort. Further research needs to be conducted on the efficacy of low-volume blood collection tubes in clinical laboratories. This study aimed to analyze the consistency of coagulation test results obtained using Gongdong and Kangjian microtubes.

Methods: In total, 50 randomly selected patients underwent coagulation tests at our hospital using Yangpu coagulation tubes, Kangjian microtubes, and Gongdong microtubes. A CX-9000 blood coagulation analyzer was employed to determine the activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen (FIB) level, D-dimer level, fibrinogen degradation product (FDP) level, and antithrombin III (AT-III) level. Additionally, linear fitting was performed with the control tube results as “X” and the inspection tube results as “Y”. The expected bias (Bx) was then calculated using the following formula: Bx = a + (b – 1) / Xc, where Xc represents the medical level. Finally, the consistency between the results from the Yangpu coagulation tubes and microtubes, as well as the consistency between the results from the Gongdong and Kangjian microtubes, was assessed using 1/2 Clinical Laboratory Improvement Amendments (CLIA)’88 as the criterion.

Results: No statistically significant differences were observed between the Yangpu tubes and both types of microtubes (P>0.05). Moreover, a strong correlation was found between the coagulation test results for the Yangpu coagulation blood tubes and those for the microtubes (P<0.05). In addition, the APTT, PT, TT, FIB, D-dimer, FDP, and AT-III results between the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements.

Conclusions: While this study demonstrates strong analytical agreement between conventional tubes and microtubes, further clinical studies are warranted to validate these findings in diverse patient cohorts and to assess the impact of tube substitution on clinical outcomes.

Keywords: Microtubes; Gongdong microtubes; Kangjian microtubes; coagulation test; blood collection

Received: 23 October 2025; Accepted: 03 December 2025; Published online: 26 January 2026.

doi: 10.21037/jlpm-2025-1-58

Highlight box

Key findings

• This study found that the coagulation test results (i.e., the activated partial thromboplastin time, prothrombin time, thrombin time, fibrinogen, D-dimer, fibrinogen degradation product, and antithrombin III results) between conventional Yangpu coagulation tubes and two types of microtubes (Gongdong and Kangjian) showed high consistency. No statistically significant differences were observed. The Gongdong and Kangjian microtube results were also highly correlated and met established quality specifications, confirming their analytical interchangeability.

What is known, and what is new?

• Vacuum blood collection tubes are essential for clinical testing, but traditional tubes have a number of limitations. Microtubes are increasingly being used to reduce required blood volumes and patient discomfort.

• This study provides new, direct comparative evidence validating the performance of specific microtube brands (Gongdong and Kangjian) against a conventional tube and against each other across a comprehensive panel of coagulation parameters, confirming their reliability in clinical laboratory settings.

What is the implication, and what should change now?

• The Gongdong and Kangjian microtubes were found to be viable and reliable alternatives for coagulation testing, supporting their broader clinical adoption. The use of microtubes could help reduce required blood volumes, benefiting patients, particularly pediatric or intensive care unit patients. Laboratories can confidently consider integrating these validated microtubes into routine practice, ensuring that pre-analytical quality control standards are maintained.

Introduction

Vacuum blood collection tubes are key tools for blood collection and separation. At present, several types of blood collection tubes are routinely used in clinical settings. However, traditional vacuum blood collection tubes can compromise the accuracy of test results due to clot adhesion to the tube wall and the absence of anticoagulant agents, which not only prolongs the time required for blood separation but also leads to protein threading (1,2). Conversely, vacuum blood collection tubes significantly improve the efficacy and accuracy of blood collection, thereby reducing sample waste while also minimizing the risk of cross-contamination (3). Vacuum-designed Gongdong and Kangjian microtubes offer numerous advantages in terms of rapid and convenient blood collection, while also limiting the risk of contamination during handling. In addition, citrate tubes can prevent blood coagulation, retaining the native state of blood samples and ensuring the accuracy of test results (4). Microtubes, designed for the collection of small-volume blood samples, are currently extensively used in clinical practice, as they significantly reduce the required blood volume and patient discomfort (5,6). This study, which was conducted from November 1, 2024, to December 30, 2024, sought to analyze the consistency of blood test results between Gongdong and Kangjian microtubes to provide a reference for the evidence-based selection of microtubes in clinical settings. We present this article in accordance with the MDAR and STARD reporting checklists (7,8) (available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-2025-1-58/rc).

Methods

Ethical statement

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of The Second Affiliated Hospital, Guangzhou Medical University (No. KY-EC2024-036), and informed consent was taken from all the patients.

General materials

In total, 50 patients (27 males and 23 females; age range, 22–78 years; mean age: 45.38±3.25 years), were randomly selected to undergo coagulation testing at The Second Affiliated Hospital, Guangzhou Medical University. The blood was collected using Yangpu coagulation tubes, Kangjian microtubes, and Gongdong microtubes.

Study methods

The Automatic Coagulation Analyzer (testing instrument name/equipment number: CX-9000; Brand: Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China) was used as the testing instrument. The parameters of the matching reagent kits, micro blood collection tubes, quality controls, and calibrators were listed in Tables 1-4, respectively.

Table 1

The parameters of the matching reagent kits

Kits Methods/model Batch No. Period of validity
APTT Coagulation 0224070121 2025-10-31
PT Coagulation 0124060111 2025-10-21
TT Coagulation 0324070111 2025-11-06
FIB Coagulation 0424070111 2025-08-05
D-dimer Immunoturbidimetry 0524070111 2025-11-20
FDP Immunoturbidimetry 0624070111 2025-11-28
AT-III Chromogenic substrate 0724090111 2025-12-26
Coagulation Instrument Needle Wash Solution – 9124080129 2025-11-29
Coagulation Analyzer Diluent AF-15 0924040111 2025-11-21
Coagulation Assay Diluent DF-15 0824060111 2026-01-07

APTT, activated partial thromboplastin time; AT-III, antithrombin III; FDP, fibrinogen degradation product; FIB, fibrinogen; PT, prothrombin time; TT, thrombin time.

Table 2

The parameters of the matched micro blood collection tubes

Micro tubes Batch No. Period of validity
Gongdong 1-mL 202410122 2025-11-27
Kangjian 1-mL 078624901 2025-09-04

Table 3

The parameters of matched quality controls

Levels Batch No. Period of validity
Level 1 coagulation control 8624080218 2025-11-27
Level 2 coagulation control 8724080118 2025-11-27
Low-value D-dimer control 6224080116 2025-11-12
Medium-value D-dimer control 6324080116 2025-11-12
Low-value FDP control 6624030116 2025-03-28
Medium-value FDP control 6724030116 2025-03-28
Level 1 AT-III control 8224050218 2025-05-26
Level 2 AT-III control 8324090118 2025-12-21

AT-III, antithrombin III; FDP, fibrinogen degradation product.

Table 4

The parameters of the matched calibrators

Calibrators Batch No. Period of validity
D-dimer calibrator 7024050217 2025-05-25
FDP calibrator 7124030117 2025-03-28

FDP, fibrinogen degradation product.

The procedures were performed in accordance with the Performance Verification of Vacuum Tubes for Venous Blood Specimens (WS/T 224-2018) standard, and the Expert Consensus on Performance Evaluation of Evacuated Blood Collection Tubes in Medical Laboratories (9). Blood samples from each patient were simultaneously collected using 2-mL Yangpu coagulation tubes as the control tubes and 1-mL microtubes as the inspection tubes, with inter-patient samples used for comparative analysis. The collected samples were centrifuged (1,500 ×g, 15 minutes) within 4 hours of collection, and a coagulation analyzer (CX9000) was used to measure the following seven parameters: activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen (FIB) level, D-dimer level, fibrinogen degradation product (FDP) level, and antithrombin III (AT-III) level. All operations were carried out under aseptic conditions to prevent contamination and ensure the accuracy of the results. In addition, instrument performance stability was maintained to ensure the reliability of the results.

Linear fitting was conducted on the validated test data for all samples, with the results from the control tubes designated as “X,” and those from the inspection tubes designated as “Y.” The acceptance criterion was set at r≥0.975 (or R2≥0.95). Expected bias (Bx) was calculated using the following formula: Bx = a + (b – 1) / Xc, where Xc represents the medical level, a represents the intercept of the linear fit, and b represents the slope of the linear fit. Relative bias (Rb) was calculated using the following formula: Rb = Bx / Xc ×100%. The Rb for each parameter was required to meet the minimum analytical quality standards set by Clinical Laboratory Improvement Amendments (CLIA) 1988 of United States. The judgment criteria are detailed in Table S1.

Statistical analysis

The statistical analysis was conducted using SPSS 26.0 software. The normality of the data distribution for all continuous variables was assessed using the Shapiro-Wilk test. The continuous variables are expressed as the mean ± standard deviation, and were compared using the t-test. The categorical variables are presented as the number of cases and percentage, and were compared using the Chi-squared test. One-way analysis of variance was applied for comparisons between multiple groups. Kappa analysis was performed to analyze the consistency of blood test results between the Yangpu coagulation tubes and microtubes, with higher correlation coefficients (r values) reflecting stronger correlations. A P value <0.05 was considered statistically significant.

Results

Analysis of the consistency of blood test results between the Yangpu coagulation tubes and microtubes

As anticipated, no significant differences were observed in the blood test results between the Yangpu coagulation blood tubes and microtubes (P>0.05). Additionally, strong correlations were found between the blood test results for the Yangpu coagulation blood tubes and microtubes (P<0.05). For further details, see Tables S2,S3.

Comparison of test results between the Kangjian and Gongdong microtubes

The APTT test results for the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. For further details, see Tables S4,S5 and Figure 1. Similarly, the PT test results for the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. For further details, see Tables S6,S7 and Figure 2. The TT test results for the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. For further details, see Tables S8,S9 and Figure 3. Likewise, the FIB test results for the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. For further details, see Tables S10,S11 and Figure 4. The D-dimer test results for the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. For further details, see Tables S12,S13 and Figure 5. The FDP test results for the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. For further details, see Tables S14,S15 and Figure 6. The AT-III test results for the Kangjian and Gongdong microtubes were highly correlated and met the specification requirements. For further details, see Tables S16,S17 and Figure 7.

Figure 1 APTT correlation results between the tested microtubes and control tubes: (A) Gongdong microtubes; (B) Kangjian microtubes. APTT, activated partial thromboplastin time.
Figure 2 PT correlation results between the tested microtubes and control tubes: (A) Gongdong microtubes; (B) Kangjian microtubes. PT, prothrombin time.
Figure 3 TT correlation results between the tested microtubes and control tubes: (A) Gongdong microtubes; (B) Kangjian microtubes. TT, thrombin time.
Figure 4 FIB correlation results between the tested microtubes and control tubes: (A) Gongdong microtubes;(B) Kangjian microtubes. FIB, fibrinogen.
Figure 5 D-D correlation results between the tested microtubes and control tubes: (A) Gongdong microtubes; (B) Kangjian microtubes. D-D, D-dimer.
Figure 6 FDP correlation results between the tested microtubes and control tubes: (A) Gongdong microtubes; (B) Kangjian microtubes. FDP, fibrinogen degradation product.
Figure 7 AT-III correlation results between the tested microtubes and control tubes: (A) Gongdong microtubes; (B) Kangjian microtubes. AT-III, antithrombin III.

Discussion

The industrial standards outlined in Performance Verification of Vacuum Tubes for Venous Blood Specimens (WS/T 224) (9) and Collection and Processing of blood Specimens for Clinical Chemistry (WS/T 225) (10) (issued by the National Health Commission of the People’s Republic of China in 2018 and 2024, respectively) stipulate the use of disposable vacuum blood collection tubes for the clinical testing of blood specimens to ensure the standardization of blood specimen collection and processing. High-quality blood collection containers play a decisive role in pre-analytical quality control. Vacuum blood collection tubes contain various additives such as separator gel, procoagulants, anticoagulants, and surfactants. Notably, the material composition of tubes can influence the results (11).

Vacuum blood collection tubes are widely used in hospital laboratories and other departments. Following advances in laboratory medicine, instruments, and equipment, increasingly stringent requirements have been established to ensure the quality of pre-analytical blood specimens. Consequently, higher requirements have also been imposed on the quality of vacuum blood collection tubes, as these can directly impact the results (12). A previous study highlighted the importance of ensuring the material integrity and manufacturing quality of blood collection tubes, given that these can affect the coagulation function indicators (13). This need arises due to the substantial variability in the production scale, processes, and quality control practices across manufacturers of disposable vacuum blood collection tubes (14).

Notably, the Gongdong and Kangjian microtubes are composed of high-quality plastic with high durability and transparency, as well as high-performance cap-sealing technologies to mitigate the risk of blood sample leakage. More importantly, the strictly selected citrate tubes have been scientifically engineered for ease of operation (15). Prior to the use of vacuum blood collection tubes, the integrity of the seal had to be verified to prevent external contamination. Additionally, the risk of leakage and tube breakage had to be mitigated to ensure the safety and accuracy of blood.

Prior to blood collection, vacuum blood collection tubes with appropriate specifications should be selected to match the required volume. During blood collection, accidental dropping or compression should be avoided to ensure the results are not compromised (16). Further, appropriate venipuncture sites need to be selected to minimize the risk of insufficient blood collection or blood leakage. Following blood collection, the valve should be closed in a timely manner to avoid contamination or blood spillage. Further, blood collection tubes should also be handled correctly without direct exposure to blood to limit the risk of disease spread (17). Blood collection tubes must also be categorized and disposed of to prevent environmental pollution.

Blood collection tools should be thoroughly cleaned and sterilized to maintain operational safety. The complete sterilization of blood collection tubes before use has significant implications for preventing adverse outcomes. Meanwhile, blood reflux during collection may prolong waiting times and potentially result in sepsis. Notably, the microbial contamination of additives in blood collection tubes can result in mildew, which can not only affect the accuracy of the test results but can also damage laboratory instruments (18). The industrial standard [Single-Use Containers for Human Venous Blood Specimen Collection (YY0314-2007)] mandates that in cases where the possibility of direct contact between the tube and blood cannot be excluded, the blood collection tubes must be sterile (19). The National Technical Committee on Infusion Equipment for Medical Use notes the possibility of direct contact between the tube and blood during blood collection using vacuum blood collection tubes. The Guidelines for Technical Review of Registration for Disposable Vacuum Blood Collection Tubes explicitly state that blood collection tubes should be supplied in a sterile state during the registration review, and comply with all laws and regulations governing the production of sterile medical devices in China (20).

This study found a strong correlation between the test results obtained from the Yangpu coagulation tubes and those obtained from the microtubes (P<0.05), highlighting the clinical utility of microtubes, which is supported by their analytical reliability comparable to conventional tubes and their advantage of requiring a smaller blood volume. The APTT, PT, TT, FIB, D-dimer, FDP, and AT-III test results for the Kangjian and Gongdong microtubes exhibited a high correlation and met the specification requirements, signifying that the microsampling approach declared by the manufacturers was suitable for laboratory application. Using the 2-mL sample tubes used in the hospital as controls, the consistency evaluation revealed that the APTT results obtained from the microtubes demonstrated a more favorable aging profile than those of conventional control tubes. Compared with the control tubes, the deviations in PT, TT, D-dimer, FIB, AT-III, and APTT at critical values or within reference ranges for the Kangjian and Gongdong microtubes met the minimum quality standards.

This study has several limitations that should be considered when interpreting the results. First, the study was conducted at a single clinical center with a relatively limited sample size of 60 patients. While sufficient for the statistical comparisons performed, a larger, multi-center study would help to confirm the generalizability of our findings across diverse patient populations and different laboratory environments. Second, the methodological comparison relied on designated control tubes (Yangpu) as the reference standard. Although this is a standard practice, it is recognized that the comparator method itself has inherent analytical variation, a common constraint in method validation studies. Finally, the study focused on a predefined panel of coagulation parameters, the performance of these microtubes with other specialized coagulation assays was not evaluated. Despite these limitations, the results consistently demonstrated high concordance across all key parameters, supporting the main conclusion that the microtubes are a reliable alternative for routine coagulation testing.

Conclusions

Both Yangpu blood coagulation tubes and microtubes can be used as microtubes for clinical blood testing, as evidenced by the strong correlation in their test results, and the high degree of consistency between the test results of the Gongdong and Kangjian microtubes. Further clinical studies are warranted to validate these findings in diverse patient cohorts and to assess the impact of tube substitution on clinical outcomes.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the MDAR and STARD reporting checklists. Available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-2025-1-58/rc

Data Sharing Statement: Available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-2025-1-58/dss

Peer Review File: Available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-2025-1-58/prf

Funding: This work was supported by Wu Jieping Medical foundation (No. 320.6750.2024-06-42).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-2025-1-58/coif). K.W. and D.L. are from Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of The Second Affiliated Hospital, Guangzhou Medical University (No. KY-EC2024-036) and informed consent was taken from all the patients.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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(English Language Editor: L. Huleatt)

doi: 10.21037/jlpm-2025-1-58
Cite this article as: Lin M, Luo M, Wang K, Li D, Zhou Y, Yang J, Wang M, Wang Z, Zhou Q. Applied research on micro blood collection tubes in clinical coagulation testing. J Lab Precis Med 2026;11:4.

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