PMID- 31799361
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220411
IS  - 2352-5517 (Print)
IS  - 2352-5517 (Electronic)
IS  - 2352-5517 (Linking)
VI  - 17
DP  - 2019 Nov
TI  - Performance of 6 routine coagulation assays on the new Roche Cobas t711 analyzer.
PG  - e00146
LID - 10.1016/j.plabm.2019.e00146 [doi]
LID - e00146
AB  - OBJECTIVES: For new analyzers or tests, analytical evaluation is required before 
      implementation in the clinical laboratory. We evaluated the novel Roche Cobas 
      t711 analyzer with six newly developed coagulation assays: the activated partial 
      thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio 
      (INR), fibrinogen, d-dimer and anti-Xa. The evaluation included imprecision 
      experiments, method comparison with the currently used Stago STA-R Evolution, 
      monitoring of unfractionated heparin (UFH) with aPTT, a fast centrifugation 
      protocol to improve turn-around time, and determination of sample stability in 
      whole blood and plasma. DESIGN AND METHODS: Imprecision and method comparison 
      were assessed using commercial quality control samples and patient samples, 
      respectively. For dose monitoring of UFH with the aPTT, samples from patients 
      treated with UFH were used. Samples from healthy volunteers were collected for 
      evaluation of the fast centrifugation protocol (5' 2750xg) and for investigating 
      sample stability over 6-8 h. RESULTS: Results for between-run precision were 
      within the desirable specification. Method comparison showed an excellent 
      agreement for fibrinogen, d-dimer and anti-Xa. For aPTT, PT and INR, a good 
      correlation was found, but results were significantly lower on the t711 compared 
      to the STA-R Evolution, which is caused by different coagulation activators. 
      Results from the fast centrifugation protocol differed not significantly from the 
      standard protocol (15' 2500xg). Blood and plasma samples were stable at room 
      temperature up to 6 and 8 h, respectively. CONCLUSIONS: The t711 coagulation 
      analyzer with 6 novel tests is suitable for routine use in clinical laboratories.
CI  - (c) 2019 The Authors. Published by Elsevier B.V.
FAU - Oostendorp, Marlies
AU  - Oostendorp M
AD  - Laboratory of Clinical Chemistry, Deventer Hospital, Deventer, the Netherlands.
AD  - Department of Clinical Chemistry and Hematology, Rijnstate Hospital, Arnhem, the 
      Netherlands.
FAU - Noorman, Roefke L
AU  - Noorman RL
AD  - Laboratory of Clinical Chemistry, Deventer Hospital, Deventer, the Netherlands.
FAU - Nijenhuis, J Dinant
AU  - Nijenhuis JD
AD  - Laboratory of Clinical Chemistry, Deventer Hospital, Deventer, the Netherlands.
FAU - de Kok, Jacques B
AU  - de Kok JB
AD  - Laboratory of Clinical Chemistry, Deventer Hospital, Deventer, the Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20191109
PL  - Netherlands
TA  - Pract Lab Med
JT  - Practical laboratory medicine
JID - 101690848
PMC - PMC6881685
OTO - NOTNLM
OT  - Analytical performance
OT  - Coagulation assays
OT  - Cobas t711
OT  - INR, International normalized ratio
OT  - LMWH, Low molecular weight heparin
OT  - PT, Prothrombin time
OT  - Sample stability
OT  - UFH, Unfractionated heparin
OT  - Unfractionated heparin
OT  - aPTT, Activated partial thromboplastin time
COIS- The authors have no conflicts of interest to declare.
EDAT- 2019/12/05 06:00
MHDA- 2019/12/05 06:01
PMCR- 2019/11/09
CRDT- 2019/12/05 06:00
PHST- 2019/07/30 00:00 [received]
PHST- 2019/10/24 00:00 [revised]
PHST- 2019/11/06 00:00 [accepted]
PHST- 2019/12/05 06:00 [entrez]
PHST- 2019/12/05 06:00 [pubmed]
PHST- 2019/12/05 06:01 [medline]
PHST- 2019/11/09 00:00 [pmc-release]
AID - S2352-5517(19)30082-4 [pii]
AID - e00146 [pii]
AID - 10.1016/j.plabm.2019.e00146 [doi]
PST - epublish
SO  - Pract Lab Med. 2019 Nov 9;17:e00146. doi: 10.1016/j.plabm.2019.e00146. 
      eCollection 2019 Nov.