Comparative evaluation of two different blood collection tubes for hematological and biochemical testing

Abstract

Background

Blood collection tubes can influence sample stability and analytical accuracy. We compared two different commercially available tube systems, Vacutainer® (BD) and Vacusera® (Disera), assessing stability of hematological and biochemical parameters under various preanalytical conditions.

Methods

Residual blood samples from routine laboratory testing were aliquoted into both different tubes. Parameters measured included Red blood cells (RBC), White blood cells (WBC), Hemoglobin (Hb), Potassium (K), Chloride (Cl), Sodium (Na), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Lactate dehydrogenase (LDH), along with hemolysis index. Preanalytical variables included storage temperature (ambient vs 4 °C), storage time (T₀, 1h, 3h, 24h), and transport conditions (local vs remote collection sites, with/without pre-centrifugation).

Results

From January 27 to July 31, 2025, 95 samples were analyzed: 49 from the Castellanza Hospital site, located approximately 50 km from the main laboratory (26 stored at room temperature, 23 at 4 °C), and 46 from the Fantoli MultiLab Laboratory (25 samples at room temperature, 21 at 4 °C), yielding 6621 determinations. Comparative analysis demonstrated no clinically significant differences between the two tube types under all tested conditions. Minor variations in K, Na and LDH (Castellanza Hospital site), Hb and ALT (Fantoli MultiLab Laboratory) were within acceptable analytical variation. Hemolysis index remained comparable between tubes in all scenarios, including transport and delayed processing.

Conclusion

Vacutainer® (BD) and Vacusera® (Disera) tube systems showed analytical equivalence across hematology and biochemistry parameters under multiple preanalytical conditions. We conclude that the tubes are suitable for common clinical hematological use and show acceptable performance for common clinical chemistry parameters.

1. Introduction

The pre-analytical phase, including patient preparation, sample collection, handling, transportation, storage and preparation for testing, is a critical determinant of laboratory result quality [1]. Accurate assessment of pre-analytical factors is essential to ensure that the stored materials accurately reflect the original biomaterial intended for analysis [2]. Errors at this stage can compromise result validity and often remain unnoticed until post-analytical review [3,4].

Preanalytical variability is particularly critical in cardiovascular care, where small differences in electrolytes (especially potassium) may influence arrhythmia risk assessment and urgent therapeutic decisions.

Among pre-, analytical, and post-analytical steps, the preanalytical phase generally regarded as the major contributor to total testing variability, and, unlike many analytical and post-analytical factors, several of its sources of error can be minimized through standardized procedures. Various pre-analytical factors may lead to variable and non-reproducible diagnostic results [1,[5], [6], [7]]. Indeed, a recent study confirmed that preanalytical errors remain a major source of variability in hematology laboratories, with insufficient sample volume as the most frequent issue [6,8]. These findings emphasize the ongoing relevance of monitoring and standardizing the pre-analytical phase in routine laboratory workflows. The type of collection tube can also affect the integrity of blood samples. In particular, the composition of the tube material, additives, gel properties, and vacuum systems can affect sample stability, clotting behavior, and analytes concentration. For instance, it was demonstrated that switching from glass to plastic tubes could lead to significant differences in the measurement of several hormones and biochemical analytes, primarily due to surface adsorption phenomena and differences in material properties [9]. Serum separator tubes (SSTs) and ethylenediaminetetraacetic acid (EDTA) tubes are widely used in clinical laboratories. EDTA-anticoagulated blood has long been the standard specimen for hematological analyses and it may differ in its formulation, concentration, or application method among tube manufacturers [10]. Anticoagulant formulation or surface treatment may lead to variable platelet activation, adsorption of proteins or metabolites to tube walls, or alterations in the rate of clot formation [11].

Several studies have reported that, although K₂EDTA is the standard anticoagulant for hematology, analytical variability may arise between tubes from different manufacturers like Vacutainer®, Vacuette®, Venosafe®, and other K₂EDTA systems [12,13]. These comparative evaluations have shown minor but measurable differences in selected hematological and biochemical parameters, likely attributable to variations in tube material, additive formulation, or manufacturing process [11]. These findings highlight that even minor manufacturing or additive differences between tube brands may influence analytical outcomes. Similarly, it was demonstrated comparable analytical performance between V-Tube™, VQ-Tube™, K₂EDTA V-Tube™ Improvacuter® K₃EDTA tube and BD Vacutainer® K₂EDTA system, with differences that were not clinically significant [14,15].

Becton Dickinson (BD) (Franklin Lakes, NJ, USA) and Greiner Bio-One (Monroe, NC, USA) are two of the main manufacturers of vacuum tubes. Given that Vacusera® (Disera) tubes have been increasingly adopted as an additional system, it is essential to verify whether their analytical and preanalytical performance is comparable under typical laboratory workflows. BD Vacutainer® tubes contain spray-dried K₂EDTA anticoagulant applied to the inner wall of the evacuated tube, a design widely used to maintain a consistent blood-to-additive ratio and minimize preanalytical variation [11].

In contrast, Vacusera® (Disera) tubes also use K₂EDTA as the anticoagulant, although the manufacturer provides limited publicly available technical detail regarding the exact application method (spray-dried vs. liquid). According to the product specification, Vacusera® tubes comply with ISO 6710 manufacturing standards, which ensure appropriate additive distribution and vacuum accuracy, but do not disclose the specific EDTA-coating technology [16].

Therefore, this study aims to evaluate Vacusera® (Disera) vacuum tubes in comparison with the Vacutainer® (Becton Dickinson) vacuum tubes currently used at IRCCS Multimedica, by analyzing a panel of hematological parameters and assessing their performance in preserving sample integrity under varying preanalytical conditions. Specifically, the study measured hematological indices, key biochemical analytes, as well as the hemolysis index as a marker of sample quality.

2. Materials and methods

2.1. Study design

This was an in vitro comparative study conducted between January 27 and July 31, 2025, using residual whole-blood samples obtained from routine diagnostic testing, in accordance with ethical principles. The study was conducted following the SIBioC operational protocol for method comparison [17].

The experimental workflow is illustrated in Fig. 1, and includes three phases:

• 1.Sample preparation, including standardized blood collection and handling to ensure comparability between Vacutainer® (referred to as Tube Type 1, reference system) and Vacusera® (referred to as Tube Type 2, test system).
• 2.Sample stability assessment, focusing on the predefined hematological and biochemical parameters (RBC, WBC, Hb, K, Na, Cl, AST, ALT, and LDH) and the hemolysis index as an indicator of sample integrity.
• 3.Evaluation of storage and transport effects, assessing tube performance after controlled storage at different temperatures and defined time intervals, as well as under varying simulated transport durations.

Fig. 1.

Schematic representation of the experimental workflow. Blood samples were collected at two sites, aliquoted into Vacutainer® (Tube Type 1) and Vacusera® (Tube Type 2), and analyzed at baseline (T₀), 1 h, 3 h, and 24 h after storage at room temperature (RT) or 4 °C. Figure created with BioRender.com.

All analytical measurements were performed under standardized laboratory conditions.

2.2. Sample collection and distribution

Residual whole blood samples were collected from hospitalized and ambulatory patients at the IRCCS MultiMedica network, Fantoli MultiLab and Castellanza hospital (Milan, Italy). A residual portion of each specimen (post-diagnostic discard) was anonymized and used for experimental analysis. The study was conducted under the approval of the Comitato Etico Prot. Nr. 378/24 (Comitato Etico Territoriale Lombardia, Italy) of 23.07.2024 to IRCCS MultiMedica (Milan, Italy), in compliance with the Declaration of Helsinki and institutional biosafety standards. No additional sampling or patient data collection was required for this study.

Samples were divided into matched tubes immediately after routine processing. For the Tube Type 1, two tube types were tested: EDTA K₂, 4 mL (Ref. BD 368861) and serum separator tube with gel, 5 mL (Ref. BD 367955). The Tube Type 2 was selected in equivalent EDTA K2, 4 ml (Ref. Disera 234604) and serum separator tube with gel, 5 mL (Ref. Disera 235305) both intended for the same analytical applications and under the same preanalytical conditions. A total of 95 paired samples were tested: 49 from the Castellanza hospital site, located approximately 50 km from the main laboratory (26 RT, 23 at 4 °C) and 46 from Fantoli MultiLab Laboratory, the main laboratory. (25 RT, 21 at 4 °C).

2.3. Preanalytical and analytical parameters

Sample integrity was assessed primarily by visual inspection, verifying that both tube types preserved comparable specimen quality, defined by the absence of visible hemolysis or other physical alterations. For clinical chemistry samples, hemolysis was additionally quantified using the Atellica® Solution analyzer, which provides a semi-quantitative hemolysis index ranging from 0 (no hemolysis) to 3+ (marked hemolysis). For hematology samples, for which the XN-9000 analyzer does not report a hemolysis index, hemolysis was assessed exclusively by macroscopic inspection, and no visibly hemolyzed specimens were identified. To assess whether both systems equally preserve consistent analytical results, a panel of hematological parameters (RBC, WBC, and Hb) was analyzed using the XN-9000 analyzer (Sysmex Europe, Hamburg, Germany), and biochemical parameters (K, Cl, Na, AST, ALT, and LDH) were measured using the Atellica® Solution system (Siemens Healthcare, Germany). Sample measurements were performed in both tubes at the same times with the same analytical platforms and instruments, in order to minimize procedural variability and ensure direct comparability of results.

The preanalytical variables considered in this study included storage temperature, storage time, and transport conditions. First, to assess the impact of temperature on sample stability, samples were stored either at room temperature (RT) or under refrigeration at 4 °C. Second, to evaluate the effect of time, samples were analyzed at T₀ (baseline, immediately after distribution into paired tubes) and after 1 h, 3 h, and 24 h of storage under controlled temperature conditions. Finally, to investigate the potential influence of transport, samples collected locally (Fantoli MultiLab Laboratory) were compared with those collected remotely (Castellanza). Although samples were collected at two different hospital sites, all analytical measurements were performed exclusively at the Fantoli MultiLab Laboratory using the same instruments (Sysmex XN-9000 and Siemens Atellica® Solution). No analyses were performed at the Castellanza site.

From Castellanza site, samples were transported with or without pre-centrifugation, allowing us to assess the combined effect of distance and handling procedures on preanalytical stability. These conditions were selected to simulate common preanalytical scenarios encountered in routine laboratory workflows and to assess their potential effect on hemolysis, sample stability, and analytical accuracy.

All samples were transported to the laboratory under controlled and temperature-monitored conditions, in accordance with regional regulations for biological material transport, ensuring no seasonal or environmental influence on sample stability.

2.4. Statistical analysis

The paired t-test and Bland-Altman analysis were applied to all comparisons between analytes at baseline (T₀) and room temperature. The level of statistical significance was set at p < 0.05. For other temperature and storage conditions, only analytes with statistically significant differences are reported. The mean difference (Tube Type 1 mean– Tube Type 2 mean) represents the analytical bias between tube types. The mean bias (%) between tube types, calculated as ((Tube Type 2 – Tube Type 1)/Tube Type 1) x 100, was calculated for all parameters and compared with the current total allowable error (TEa) based on biological variation [18,19]. Passing–Bablok regression analysis was performed to assess the agreement and proportional or constant bias between the two tube systems. Clinical relevance was defined according to the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) biological variation database. All analyses were conducted using GraphPad Prism version 8.0.1 (GraphPad Software, San Diego, CA, USA).

3. Results

3.1. Comparison evaluation at baseline

The statistical results of the preanalytical comparison between Tube Type 1 and Tube Type 2 at baseline (T₀) and room temperature are summarized in Table 1 (Castellanza Hospital site) and in Table 2 (Fantoli MultiLab Laboratory). The corresponding Bland–Altman plots comparing the observed differences are presented for the Castellanza Hospital site (Fig. 2A–I) and for the Fantoli MultiLab Laboratory (Fig. 3A–I).

Table 1.

Comparison of hematological and biochemical parameters at baseline (T₀) between Tube Type 1 and Tube Type 2 tubes at room temperature (Castellanza Hospital site).

Parameter	Sample size	Mean Tube Type 1 ± SD	Mean Tube Type 2 ± SD	Bias ± SD Bland Altman	p-value	Bias (LoA)	Mean Bias %	TEa	Clinical significance
RBC ( × 1012/L)	26	4,19 ± 0,83	4221 ± 0,83	−0,022 ± 0,196	0,7254	−0,022 (−0,40 + 0,361)	+0,64	6.7 %	ns
WBC ( × 109/L)	26	7,09 ± 3641	7090 ± 3,7143	0,008 ± 0,213	0,9353	0,0080 (−0,41 + 0,4274)	−0,27	14.2 %	ns
Hb (g/L)	25	124,76 ± 23,9	125,48 ± 24,36	−0,72 ± 5029	0,7321	−0,72 (−10,58 + 9137)	+0,61	3.9 %	ns
K (mmol/L)	26	4,40 ± 0,512	4,39 ± 0,504	0,013 ± 0,032	∗0,0310	0,0134 (−0,05 + 0,07)	−0,29	4.9 %	ns
Cl (mmol/L	26	104,98 ± 3,05	104,50 ± 2952	0,484 ± 1429	0,1085	0,48 (−2,31 + 3,28)	−0,45	1.2 %	ns
NA (mmol/L)	26	139,97 ± 3001	139,20 ± 3376	0,765 ± 1806	∗∗ 0,0050	0,7658 (−2,77 + 4,30)	−0,55	0.7 %	ns
AST (U/L)	26	27,30 ± 17,73	26,73 ± 17,55	0,57 ± 2715	0,1916	0,5769 (−4,74 + 5,89)	−1,26	12.4 %	ns
ALT (U/L)	26	35,23 ± 36,3	34,80 ± 36,18	0,42 ± 1,33	0,1057	0,423 (−2187 + 3,03)	−1,04	18.5 %	ns
LDH (U/L)	26	211,96 ± 46,01	211,15 ± 45,62	0,807 ± 1674	∗0,0284	0,807 (−2473 + 4088)	−0,36	6.8 %	ns

Data are presented as mean ± SD. Statistical analysis was performed using paired t-test. Mean differences (Tube Type 1 mean - Tube Type 2 mean) correspond to the analytical bias between tube types. Mean bias (%) was calculated as average percentage difference between the two tubes types: ((Tube Type 2 −Tube type 1/Tube Type 1) × 100. Statistical significance was defined as p < 0.05. Symbols: ns = not significant; ∗ = p < 0.05; ∗∗ = p < 0.01; ∗∗∗ = p < 0.001; ∗∗∗∗ = p < 0.0001. Bias mean % was evaluated against the corresponding total allowable error (TEa) based on biological variation to assess clinical relevance.

Table 2.

Comparison of hematological and biochemical parameters at baseline (T₀) between Tube Type 1 and Tube Type 2 at room temperature (Fantoli MultiLab Laboratory).

Parameter	Sample size	Mean Tube Type 1 ± SD	Mean Tube Type 2 ± SD	Bias ± SD	p-value	Bias (LoA)	Mean Bias %	TEa	Clinical significance
RBC ( × 1012/L)	25	4,78 ± 0,509	4,75 ± 0,88	0,033 ± 0,83	0,0515	0,033 (−1,60 + 1672)	−0,45	6.7 %	ns
WBC ( × 109/L)	25	6,65 ± 1,68	6,56 ± 1,45	−0,014 ± 0,907	0,5377	−0,014 (−1,79 + 1764)	+2,33	14.2 %	ns
Hb (g/L)	25	144,88 ± 13,94	139,52 ± 13,55	5,36 ± 13,61	∗∗∗0,0005	5,36 (−21,32 + 32,04)	−3,36	3.9 %	ns
K (mmol/L)	25	4,31 ± 0,44	4,30 ± 0,43	0,011 ± 0,03	0,3093	0,011 (−0,06 + 0,085)	−0,23	4.9 %	ns
Cl (mmol/L)	25	105,08 ± 2,74	104,76 ± 2,85	0,312 ± 0,760	0,0629	0,312 (−1,17 + 1802)	−0,30	1.2 %	ns
NA (mmol/L)	25	142,97 ± 1,94	142,47 ± 1,87	0,45 ± 1,01	0,1058	0,455 (−1,52 + 2436)	−0,32	0.7 %	ns
AST (U/L)	25	22,12 ± 7,10	21,56 ± 7,34	0,56 ± 3015	0,3739	0,576 (−5,34 + 6469)	−2,97	12.4 %	ns
ALT (U/L)	25	21,52 ± 12,29	19,76 ± 11,322	1,76 ± 3,58	∗∗0,0077	1760 (−5,26 + 8788)	−4,87	18.5 %	ns
LDH (U/L)	25	201,44 ± 57,38	202,08 ± 57,99	−0,640 ± 1551	0,0575	−0,640 (−3,68 + 2401)	+0,28	6.8 %	ns

Data are presented as mean ± SD. Statistical analysis was performed using paired t-test. Mean differences (Tube Type 1 mean- Tube Type 2 mean) correspond to the analytical bias between tube types. Mean bias (%) was calculated as average percentage difference between the two tubes types: ((Tube Type 2 −Tube type 1/Tube Type 1) × 100. Statistical significance was defined as p < 0.05. Symbols: ns = not significant; ∗ = p < 0.05; ∗∗ = p < 0.01; ∗∗∗ = p < 0.001; ∗∗∗∗ = p < 0.0001. Bias mean % was evaluated against the corresponding total allowable error (TEa) based on biological variation to assess clinical relevance.

Fig. 2.

Bland–Altman plots comparing Tube Type 1 and Tube Type 2 at baseline (T₀) and at room temperature from Castellanza Hospital site. The y-axis represents the difference between the two measurements (Tube Type 1- Tube Type 2), while the x-axis shows the mean of the paired values. The solid line represents the mean bias, indicating the average difference between tube types. The dashed lines denote the 95 % limits of agreement (LoA), calculated as the mean difference ± 1.96 × SD (upper limit = UL; lower limit = LL). The shaded area corresponds to the range between these limits, within which approximately 95 % of the paired differences are expected to fall. (A) RBC, (B) WBC, (C) Hb, (D) K, (E) Na, (F) Cl, (G) AST, (H) ALT, (I) LDH.

Fig. 3.

Bland–Altman plots comparing Tube Type 1 and Tube Type 2 tubes at baseline (T₀) and at room temperature from Fantoli MultiLab Laboratory. The y-axis represents the difference between the two measurements (Tube Type 1 - Tube Type 2), while the x-axis shows the mean of the paired values. The solid line represents the mean bias, indicating the average difference between tube types. The dashed lines denote the 95 % limits of agreement (LoA), calculated as the mean difference ± 1.96 × SD (upper limit = UL; lower limit = LL). The shaded area corresponds to the range between these limits, within which approximately 95 % of the paired differences are expected to fall. (A) RBC, (B) WBC, (C) Hb, (D) K, (E) Na, (F) Cl, (G) AST, (H) ALT, (I) LDH.

A total of 6621 individual determinations were performed across all parameters and preanalytical conditions, providing strong statistical robustness for the comparative evaluation.

At the Castellanza site, none of the hematological parameters (RBC, WBC, Hb) measured at T₀ and room temperature showed statistically significant differences, confirming full analytical equivalence between the two tube systems. Among biochemical parameters (K, Na, Cl, AST, ALT, LDH), only three analytes (K, Na and LDH) showed statistically significant differences (p < 0.05). However, in all cases, the observed mean bias (%) values and limits of agreement (LoA) values remained well within TEa recommended by the EFLM, and the number of outliers was limited, demonstrating that these variations were analytically and clinically insignificant (Fig. 2D and E–I). Similarly, at the Fantoli MultiLab Laboratory, although Hb and ALT reached statistical significance, the mean differences were small, and Bland–Altman analysis confirmed that all values remained within the corresponding TEa limits, indicating no clinically meaningful bias between two systems (Fig. 3C–H).

In addition, Passing–Bablok regression analysis was performed to evaluate the agreement of the comparison for all analytes measured at baseline (T₀) and room temperature. The regression plots are shown for Castellanza Hospital site (Fig. 4A–I) and those for Fantoli MultiLab Laboratory (Fig. 5A–I).

Fig. 4.

Passing-Bablok regression analysis comparing Tube Type 1 and Tube Type 2 at baseline (T₀) and at room temperature from Castellanza Hospital site. (A) RBC, (B) WBC, (C) Hb, (D) K, (E) Na, (F) Cl, (G) AST, (H) ALT, (I) LDH. For K, Na e Cl the axis range was adjusted to reflect only the actual measured data interval, improving visual readability. This graphical adjustment does not affect regression results or the associated statistics.

Fig. 5.

Passing-Bablok regression analysis comparing Tube Type 1 and Tube Type 2 at baseline (T₀) and at room temperature from Fantoli MultiLab Laboratory. (A) RBC, (B) WBC, (C) Hb, (D) K, (E) Na, (F) Cl, (G) AST, (H) ALT, (I) LDH. For K, Na e Cl the axis range was adjusted to reflect only the actual measured data interval, improving visual readability. This graphical adjustment does not affect regression results or the associated statistics.

For both sites, the regression slopes were close to 1 and the intercepts near 0, with 95 % confidence intervals including these reference values, revealing definite linearity between the two kinds of tubes in all cases.

3.2. Stability study at different time-points, temperatures, and transport conditions

Additional comparative analyses were conducted to evaluate the stability of hematological and biochemical parameters collected in Tube Type 1 and Tube Type 2 under different preanalytical conditions, including storage at 4 °C and room temperature, as well as delayed processing at 1 h, 3 h, and 24 h. Results from both sites (Castellanza and Fantoli) are summarized in Supplementary Table 1, where only statistically significant differences are presented. Although these parameter–condition combinations showed statistically significant differences, all observed bias values and Bland–Altman LoA values remained within the corresponding TEa limits. No systematic trends were observed related to tube type, storage temperature, or delay time. These differences are considered analytically and clinically irrelevant, confirming the overall equivalence between the two tube types under all tested preanalytical conditions. All other comparisons performed for each condition showed no statistically significant differences, indicating concordance between the two methods.

Therefore, both tube types maintained parameter stability for up to 24 h at room temperature and 4 °C. Likewise, transport from the remote Castellanza Hospital site produced equivalent results to those from the local Laboratory (Fantoli MultiLab). Pre-centrifugation prior to transport did not result in clinically relevant differences in hemolysis index and did not affect the equivalence between tube types. Importantly, no increase in hemolysis was observed under any temperature or storage time scenario.

4. Discussion

A plethora of comparative studies have been published in the literature analyzing different types of blood tubes for different purposes [[12], [13], [14], [15],[20], [21], [22]]. However, a variety of new brands of blood collection tubes have been introduced recently and need continuous verification of their equivalence to established reference systems, which remains essential to ensure analytical accuracy and patient safety [23].

Preanalytical materials and blood collection devices require periodic performance evaluation and continuous monitoring, especially when implemented in routine laboratory practice.

This is highly relevant because even minor differences can affect the reliability of test results, including potential variations in analyte concentration or clotting behavior [11]. Accordingly, any systems intended for the same clinical use should be evaluated to confirm their analytical equivalence.

In this study, we demonstrated analytical equivalence between Vacusera® and Vacutainer® tubes for all hematological and biochemical parameters, even under variable preanalytical conditions, including storage time, temperature, and transport.

Although the paired t-test identified some statistically significant differences for a few analytes, all observed mean bias (%) values were within the corresponding TEa limits derived from biological variation, indicating no clinically relevant discrepancies.

Bland–Altman analysis further confirmed that the majority of results fell within the 95 % limits of agreement, and Passing–Bablok regression showed slopes close to 1 and intercepts near 0, indicating the absence of proportional or constant bias and confirming the interchangeability of the two tube systems.

Previous literature suggests that differences in tube composition may influence certain analytes, particularly potassium and LDH, due to the type of calcium-chelating anticoagulant or gel-separator interactions [11,24,25]. In the present study, however, the observed variations were minimal and well within clinically acceptable limits of analytical performance.

In line with previous findings on comparable tube systems, the results confirmed that both tubes preserve sample integrity and yield consistent analytical outcomes.

A preanalytical study evaluated the effects of sample transport on six representative laboratory parameters before and after the implementation of an integrated transport system [4]. In that study, prolonged transport times were associated with significant alterations in ALT and potassium concentrations prior to implementation. However, after the introduction of a standardized, temperature-controlled transport system, these differences were no longer observed [4]. These findings highlight that controlling temperature and transport time effectively prevents preanalytical variability. In line with these observations, our study has shown that samples remained stable for up to 24 h at both room temperature and 4 °C, with no significant variation across different storage time or transport conditions. Furthermore, transport from the remote collection Hospital Castellanza did not introduce measurable analytical differences compared to samples processed locally (Fantoli MultiLab Laboratory), supporting the robustness of both systems under real-world laboratory conditions.

In conclusion, the findings support the potential use of Vacusera® tubes as an additional to the current reference system, offering possible advantages in terms of cost optimization, without compromising analytical quality or sample integrity.

5. Conclusion

Vacusera® tubes provided equivalent analytical performance to Vacutainer® tubes for both hematology and chemistry testing under varied storage, transport, and handling conditions. Adoption of Vacusera® tubes in routine practice appears feasible and scientifically justified.

6. Limitations of this study

This study presents a limitation related to the sample management workflow. For practical and ethical reasons inherent in routine clinical practice, blood samples were initially collected in standard tubes for immediate diagnostic use and the residual material was subsequently transferred to paired tubes. Consequently, the T₀ time point did not correspond exactly to the time of collection, but rather to the start of the comparative testing procedure. While this approach reflects real-world laboratory conditions, it may introduce a slight delay between collection and experimental processing that could theoretically influence analytes stability, although this effect is expected to be minimal and uniform across different tube types.

CRediT authorship contribution statement

Michela Salvatici: Writing – review & editing, Validation, Methodology, Formal analysis, Data curation. Francesca Carreras: Writing – review & editing, Writing – original draft, Validation, Formal analysis. Monica Gaimarri: Writing – review & editing, Methodology. Francesca Delia Sansico: Writing – review & editing, Methodology. Paolo Marinoni: Writing – review & editing, Methodology. Chiara Masserini: Writing – review & editing, Methodology. Barbara Bianchi: Writing – review & editing, Methodology. Carmen Sommese: Writing – review & editing. Lorenzo Drago: Writing – review & editing, Project administration, Funding acquisition, Conceptualization.

Institutional review board statement

Following the Ethical Committee approval Prot. Nr. 378/24 (Comitato Etico Territoriale Lombardia, Italy) of 23.07.2024. Furthermore, the study was conducted in accordance with the Declaration of Helsinki.

Funding statement

This work has been supported by the Ministry of Health through the Ricerca Corrente program of IRCCS MultiMedica, and partially supported by Interconsul Srl, Italy.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Appendix A. Supplementary data

The following is the supplementary data to this article:

Data availability

Data will be made available on request.