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End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6

Scandinavian Journal of Clinical and Laboratory Investigation · Ocak 2024

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YÖKSİS Kayıtları
End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6
Scandinavian Journal of Clinical and Laboratory Investigation · 2024 SCI-Expanded
PROFESÖR ALİ ÜNLÜ →
End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6
Scandinavian Journal of Clinical and Laboratory Investigation · 2024 SCI-Expanded
PROFESÖR SEDAT ABUŞOĞLU →
End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6
Scandinavian Journal of Clinical and Laboratory Investigation · 2024 SCI-Expanded
DOÇENT GÜLSÜM ABUŞOĞLU →
End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6
Scandinavian Journal of Clinical and Laboratory Investigation · 2024 SCI-Expanded
PROFESÖR BAHADIR ÖZTÜRK →
End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6
Scandinavian Journal of Clinical and Laboratory Investigation · 2024 SCI-Expanded
PROFESÖR ALİ ÜNLÜ →
End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6
Scandinavian Journal of Clinical and Laboratory Investigation · 2024 SCI-Expanded
PROFESÖR ALİ ÜNLÜ →
End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6
Scandinavian Journal of Clinical and Laboratory Investigation · 2024 SCI-Expanded
PROFESÖR ALİ ÜNLÜ →

Makale Bilgileri

DergiScandinavian Journal of Clinical and Laboratory Investigation
Yayın TarihiOcak 2024
Cilt / Sayfa84 · 183-192
Özet Tube manufacturers use different composition of gels and blood clot activator formulations in serum tube production. Our aim was to investigate the within-tube (repeatability) and between-tube variation, concordance between comparison results of BD and VacuSEL tubes. Blood samples were collected from control subjects (n = 20) and patients (n = 30) in accordance with the CLSI GP41-A6 and CLSI GP34-A guidelines. Twenty-three clinical chemistry parameters were analysed via Roche Cobas C702 Chemistry Analyzer on T0 (0 hour) and T24 (24 hour). Mean differences % were compared with Wilcoxon matched pair test. Clinical significance was evaluated based on desirable bias according to total allowable error (TEa). VacuSEL tubes demonstrated acceptable performance for the results of 20 parameters with regards to desirable bias % limits. Lactate dehydrogenase (LD) [mean difference % (%95 confidence intervals (CI) values of BD and VacuSEL tubes at T0 [6.41% (4.80–8.01%)]; sodium (Na) and total protein (TP) at T24 [-0.27% (-0.46 to −0.07%) and −1.39% (-1.87 to −0.91), respectively] were over the desirable bias limits (LD: 4.3%, Na: 0.23% and TP: 1.36%, respectively) but not exceeding total biological variation CV % [Na: 0.5 (0.0–1.0) % and TP: 2.6 (2.3–2.7) %). %95 confidence intervals (CI) of T0 LD values overlap with within-subject biological variation % (CI) limits (LD: 5.2 (4.9–5.4) %). The differences between two tubes were not medically significant and necessarily conclusive. VacuSEL serum tubes presented comparable performance with BD serum tubes.

Yazarlar (9)

1
Sedat Abusoglu
ORCID: 0000-0002-2984-0527
2
Busra Ecer
3
Halil Guven
4
Ahmet Emre Yorulmaz
5
Muhittin Serdar
6
Ali Ünlü
ORCID: 0000-0002-9991-3939
7
Fikret Akyürek
8
Bahadır Öztürk
9
Gulsum Abusoglu

Anahtar Kelimeler

Blood collection tubes clinical chemistry laboratory preanalytical effect

Kurumlar

Acıbadem Mehmet Ali Aydınlar Üniversitesi
Istanbul Turkey
Selçuk Tip Fakültesi
Konya Turkey
Selçuk Üniversitesi
Selçuklu Turkey