Comparison of three blood collection tubes for 16 biochemical analytes and stability assessment of selected analytes: VACUETTE(®) CAT serum Sep clot activator tube, VACUETTE(®) LH lithium heparin Sep tube, and VACUETTE(®) CAT serum fast separator tube.
Author(s): Seo JD, Lee YJ, Ha C, Choi JH, Shin SH, Han HY, Kim HJ, Kim SH, Kim BS, Kim H, Moon HW, Hur M, Yun YM
Publication: Ann Clin Biochem, 2025, Vol. , Page 45632251329272
PubMed ID: 40132209 PubMed Review Paper? No
Purpose of Paper
This paper compared the levels of 16 analytes in case-matched serum/plasma that were collected in VACUETTE CAT Serum Fast Separator Tubes (SFT), CAT Serum Sep Clot Activator Tubes (SST) and lithium heparin Sep (LiHep) tubes. Effects of storing serum/plasma in the original tube for up to 5 days at 4°C on levels of glucose, potassium (K), lactate dehydrogenase (LDH), aspartate transaminase (AST), intact parathyroid hormone (iPTH), and cardiac troponin I (cTnI) were also investigated. Blood was collected from both healthy volunteers and cardiology patients.
Conclusion of Paper
When the SST was used as a reference, levels of creatine kinase-muscle/brain (CKMB) displayed clinically significant differences in serum collected (no storage) in the SFT relative to the SST at both ends of the reference range. Additionally, the difference in potassium (K) in serum collected in the SFT relative to the SST slightly exceeded the threshold for clinical significance at the mid and high medical decision limits. In contrast, levels of K, LDH, and CKMB all displayed clinically significant differences in lithium heparin plasma relative to serum collected in the SST when the SST was considered as a reference. When lithium heparin plasma was considered as the reference (ipTH and K only), iPTH levels were lower and K levels were higher in serum from both SST and SFT; and, the bias exceeded the acceptable bias at the lower limits of quantification and medical decision limits, respectively.
With 4°C storage, levels of potassium and AST increased and cTN1 decreased by more than the maximal permissible value in both serum and plasma specimens. In serum specimens, glucose increased and LDH and iPTH decreased. In plasma, glucose and LDH decreased, and iPTH was stable. The window of stability was analyte- and tube type-dependent; comparable stability was observed for glucose and K in both the SST and SFT, the longest stability for LDH and cTn1 in the SST, the longest stability for AST observed in the SFT, and the longest stability for iPTH in lithium heparin plasma.
Studies
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Study Purpose
This study compared the levels of 16 analytes in case-matched serum/plasma that were collected in VACUETTE CAT Serum Fast Separator Tubes (SFT), CAT Serum Sep Clot Activator Tubes (SST) and Lithium Heparin Sep (LiHep) tubes. Blood was collected from 99 healthy volunteers (48 men and 51 women, aged 18-73 years) and eight hospitalized cardiology patients (4 men and 4 women, aged 44-84 years) into Greiner Bio-One SST, SFT, and LiHep Tubes. The eight cardiology patients had elevated levels of cTnI either due to mild baseline elevation or transient elevation due to elective coronary angiography, but they did not have an acute myocardial infarction. Serum and plasma were separated by centrifugation at 2750 x g for 7 min. Levels of glucose, K, LDH, C-reactive protein (CRP), creatinine, aspartate transaminase (AST), alanine transferase (ALT), alkaline phosphatase (ALP), and gamma-glutamyl transferase (GGT) were quantified using a TBA-FX8 analyzer. Levels of thyroid-stimulating hormone (TSH), free thyroxine (FT4), and intact parathyroid hormone (iPTH) were assayed using a Cobase 801 analyzer, and levels of alpha fetoprotein (AFP), PSA (male specimens only), creatine kinase-muscle/brain (CK-MB), and cardiac troponin I (cTnI) were quantified using an Atellica IM 1600 analyzer. With the exception of iPTH, for which the LiHep specimen was considered the standard, levels of all analytes were compared to that of the SST serum specimen. Clinical significance was determined by estimating the mean percent difference at the medical decision limit (from Westgard’s database, international guidelines, or the assay) and comparing it to the desirable difference limit set by the European Federation of Laboratory Medicine (EFLM) or Westgard’s database.
Summary of Findings:
Levels of K and creatinine were lower and levels of ALT, ALP, AFP, PSA and CKMB were higher in serum from SST than SFT (P<0.05, all); but, only the increase in CKMB in serum from the SFT (40.39%) relative to the SST, exceeded the threshold of 14.88%. The difference in CKMB in serum from the SFT relative to the SST exceeded the threshold for clinical significance both at the lower (22.38%) and upper (20.62%) end of the reference limit. While the bias in K did not exceed the clinical significance threshold of 2.5% at the lower medical decision limit (3 mmol/L), levels of K were 3.10% and 4.04% lower in serum from the SFT than the SST at the mid and high medical decision limits (5.8 and 7.0 mmol/L, respectively).
Levels of K, creatinine, ALP and AFP were lower, and levels of LDH, ALT, PSA, TSH and CKMB were higher in lithium heparin plasma than SST serum (P<0.05, all). The differences in K (-7.19%), LDH (12.41%), and CKMB (103.51%) exceeded clinical significance thresholds (2.5%, 4.7% and 14.88%, respectively). Importantly, the difference in LDH and CKMB in lithium heparin plasma relative to SST serum exceeded the clinical significance threshold both at the lower (11.61% and 61.44%, respectively) and upper (7.66% and 58.16%, respectively) end of the reference range, but the bias in K exceeded the threshold only at the mid (5.8 mmol/L, -10.76%) and high (7.0 mmol/L, -12.34%) medical decision limit.
When compared to lithium heparin plasma, iPTH levels were lower in both serum from the SST and SFT (-4.06% and -5.73% respectively), and this bias (-11.43% and -12.08%, respectively) exceeded the acceptable bias (11.2%) at the lower limit of quantification. When lithium heparin plasma was used as the standard, the bias in K in both the SFT (6.50%) and SST (7.52%) exceeded the acceptable bias (2.5%).
Biospecimens
Preservative Types
- None (Fresh)
Diagnoses:
- Cardiovascular Disease
- Normal
Platform:
Analyte Technology Platform Carbohydrate Clinical chemistry/auto analyzer Electrolyte/Metal Clinical chemistry/auto analyzer Protein Clinical chemistry/auto analyzer Peptide Clinical chemistry/auto analyzer Glycoprotein Clinical chemistry/auto analyzer Pre-analytical Factors:
Classification Pre-analytical Factor Value(s) Biospecimen Acquisition Type of collection container/solution VACUETTE CAT Serum Fast Separator Tube (SFT)
VACUETTE CAT Serum Sep Clot Activator Tube (SST)
VACUETTE Lithium Heparin Sep (LiHep) tubes
Biospecimen Aliquots and Components Blood and blood products Plasma
Serum
-
Study Purpose
The study compared levels of glucose, potassium (K), lactate dehydrogenase (LDH), aspartate transaminase (AST), intact parathyroid hormone (iPTH), and cardiac troponin I (cTnI) in plasma/serum from VACUETTE CAT Serum Fast Separator Tube (SFT), CAT Serum Sep Clot Activator Tube (SST) and Lithium Heparin Sep (LiHep) tubes during 5 days of storage at 4°C. Blood was collected from 20 healthy volunteers into Greiner Bio-One SST, SFT, and LiHep Tubes. Serum and plasma were separated by centrifugation at 2,750 x g for 7 min. Serum and plasma were analyzed immediately and again daily during storage in the original tube at 4°C. Levels of glucose, K, LDH, and AST were quantified using a TBA-FX8 analyzer; levels of intact iPTH were assayed using a Cobase 801 analyzer; and levels of cTnI were quantified using an Atellica IM 1600 analyzer. Levels of all analytes were compared to those in serum from the SST. Clinical significance was determined by estimating the mean percent difference and comparing it to the desirable difference limit set by the European Federation of Laboratory Medicine (EFLM).
Summary of Findings:
Levels of K and AST increased and cTN1 decreased in both serum and plasma specimens when specimens were stored in the original tube at 4°C. In serum specimens, glucose increased and LDH and iPTH decreased. In plasma, glucose and LDH decreased and iPTH was stable. The window of stability was analyte- and tube type-dependent, with comparable stability for glucose and K in both the SST and SFT, the longest stability for LDH and cTn1 in the SST, the longest stability for AST observed in the SFT, and the longest stability for iPTH in plasma. In the SST, LDH and AST were stable for the 5 day period, glucose and iPTH were stable for 3 days, cTn1 was stable for 2 days and K was stable for only 1 day. In the SFT, AST was stable for the 5 day period; glucose was stable for 3 days; LDH was stable for 2 days; and cTn1, iPTH and K were stable for only 1 day. In lithium heparin plasma, iPTH was stable for 5 days; cTn1 and AST were stable for 1 day; and glucose, K and LDH all displayed clinically relevant changes after 1 day.
Biospecimens
Preservative Types
- None (Fresh)
Diagnoses:
- Normal
Platform:
Analyte Technology Platform Protein Clinical chemistry/auto analyzer Peptide Clinical chemistry/auto analyzer Electrolyte/Metal Clinical chemistry/auto analyzer Carbohydrate Clinical chemistry/auto analyzer Pre-analytical Factors:
Classification Pre-analytical Factor Value(s) Biospecimen Acquisition Type of collection container/solution VACUETTE CAT Serum Fast Separator Tube (SFT)
VACUETTE CAT Serum Sep Clot Activator Tube (SST)
VACUETTE Lithium Heparin Sep (LiHep) Tube
Storage Storage duration 0 days
1 day
2 days
3 days
5 days
Biospecimen Aliquots and Components Blood and blood products Plasma
Serum