Analytical performance evaluation of the Cobas 6000 analyzer – special emphasis on trueness verification

Gammeren, Adriaan J. van; Gool, Nelly van; Groot, M.J.M. de; Cobbaert, Christa

doi:10.1515/cclm.2008.159

Cited by 39 publications

(24 citation statements)

References 11 publications

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“…That is sup por ted by re sul ts for wit hi n-run coeffi cie nt of va ria tion that is ge ne ral ly lower than 5% (exce pt for trig lyce ri des, cho les te rol, IgA and IgM) and for be twee n-day coeffi cie nt of va ria tion lower than 10% for all tes ted ana lytes (Tab le 2). Our re sul ts on va li da tion are con sis te nt wi th tho se pu blis hed by van Gam me ren et al (11). Al thou gh re sul ts are presen ted in diff e re nt man ner, da ta for to tal im precision can be com pa red, and no sig ni fi ca nt diff e rence be tween ob tai ned re sul ts is no ted (11).…”

Section: Discussionsupporting

confidence: 65%

Validation of methods performance for routine biochemistry analytes at Cobas 6000 analyzer series module c501

2011

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182 Ab stra ctIn tro duc tion: Co bas 6000 (Roc he, Ger ma ny) is bioc he mis try ana lyzer for spec trop ho to met ric, im mu no tur bi di met ric and io n-se lec ti ve de ter mi nation of bioc he mi cal ana lytes. He re by we pre se nt ana lytical va li da tion wi th em pha sis on met hod per for man ce jud gme nt for rou ti ne ope ra tion. Ma te ria ls and met ho ds: Va li da tion was ma de for 30 ana lytes (me ta bo li tes, en zymes, tra ce ele men ts, speci fi c pro tei ns and elec tro lytes). Re sear ch in clu ded de ter mi na tion of withi n-run (N = 20) and be twee n-run im precision (N = 30), inac cu ra cy (N = 30) and met hod com pa ri son wi th rou ti ne ana lyzer (Bec kman Coul ter AU640) (N = 50). For va li da tion of com ple te ana lyti cal pro ce ss we cal cu la ted to tal er ror (TE). Re sul ts we re jud ged ac cording to qua li ty spe ci fi ca tion cri te ria gi ven by Eu ro pean Wor ki ng Group. Re sul ts: Wit hi n-run im pre ci sion CVs we re all be low 5% exce pt for cho les te rol, trig lyce ri des, IgA and IgM. Be twee n-run CVs for all ana lytes we re be low 10%. Ana lytes that did not meet the requi red spe ci fi ca tio ns for im pre ci sion we re: to tal pro tein, al bu min, cal cium, so dium, chlo ri de, im munog lo bu li ns and HDL cho les te rol. Ana lytes that did not ful fi ll requi re men ts for inac cu ra cy we re: to tal pro tein, cal cium, so dium and chlo ri de. Ana lytes that de via ted from qua li ty spe ci fi ca tio ns for to tal er ror were: to tal pro tein, al bu min, cal cium, so dium, chlo ri de and IgM. Pas si ng-Bab lok reg res sion ana lysis pro vi ded li near equa tion and 95% con fi den ce in ter val for in ter ce pt and slo pe. Com ple te ac cor dan ce with rou ti ne ana lyzer Bec kman Coul ter AU640 showed sma ll num ber of ana lytes. Ot her ana lytes showed sma ll pro por tio nal and/or sma ll con sta nt diff e ren ce and the re fo re need to be adjus ted for rou ti ne ope ra tion. Con clu sio ns: Re gar di ng low CV va lues, tes ted analyzer has sa tis fac to ry ac cu ra cy and pre ci sion and is extre me ly stab le. Exce pt for ana lytes that are co he re nt on bo th ana lyze rs, so me ana lytes requi re ad jus tmen ts of slo pe and in ter ce pt for com ple te ac cor dan ce. Key wor ds: vali da tion stu dy; che mis try tec hniques, ana lyti cal; Co bas 6000 ana lyzer; to tal er ror; Pas si ng and Bab lo ck reg res sion Original article In tro duc tionIt is we ll do cu men ted that rou ti ne la bo ra to ry wo rk is not er ror free and eff or ts ha ve been ma de to impro ve who le la bo ra to ry tes ti ng cycle and re du ce er ro rs (1). Althou gh the ana lyti cal pha se is the lea st pro ne to er ro rs, it sti ll has room for im pro ve me nt (2). For that pur po se ma ny gui de li nes, pro to co ls and spe ci fi ca tio ns for va li da tion of ana lyti cal systems are avai lab le. They all are qui te si mi lar, but some discre pan cies exi st usual ly in ac cep tan ce cri teria de pen di ng on sour ce (3-5). Qua li ty pa ra me te rs, inac cu ra cy and im pre ci ...

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Section: Discussionsupporting

confidence: 65%

Validation of methods performance for routine biochemistry analytes at Cobas 6000 analyzer series module c501

2011

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“…The Cobas analyzer is known to be highly precise. 28,29 Tail blood was analyzed for HbA1C and BG on the Cobas 6000 analyzer and EBIO plus glucose analyzer (Eppendorf AG, Hamburg, Germany), respectively. Blood samples analyzed following the 3 week insulin/vehicle intervention were taken exactly 2 h after the morning NPH insulin/vehicle injection.…”

Section: Biochemical Analysesmentioning

confidence: 99%

Effects of insulin therapy on weight gain and fat distribution in the HF/HS-STZ rat model of type 2 diabetes

Skovsø¹,

Damgaard

Fels

et al. 2015

Int J Obes

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“…Disease activity at the 15-year followup was assessed by Disease Activity Score 28-joint count (DAS28; that is, 0.56 √ tender joint count + 0.28 √ swollen joint count + 0.70 lnESR + 0.014 patient global). Serum samples were analyzed consecutively at the time of patient visit and CRP at followup was measured using the Cobas 6000 analyzer (range 1-250 mg/l) 22 .…”

Section: Rheumatologymentioning

confidence: 99%

Early Prediction of Increased Arterial Stiffness in Patients with Chronic Inflammation: A 15-year Followup Study of 108 Patients with Rheumatoid Arthritis

Provan

Angel²,

Semb³

et al. 2011

J Rheumatol

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Analytical performance evaluation of the Cobas 6000 analyzer – special emphasis on trueness verification

Abstract: Considering the excellent precision data and the result equivalence for most assays, it can be concluded that Cobas 6,000 accommodates robust chemistry and immunochemistry, and has good potential for workstation consolidation in medium-sized laboratories.

Cited by 39 publications

References 11 publications

Validation of methods performance for routine biochemistry analytes at Cobas 6000 analyzer series module c501

Validation of methods performance for routine biochemistry analytes at Cobas 6000 analyzer series module c501

Effects of insulin therapy on weight gain and fat distribution in the HF/HS-STZ rat model of type 2 diabetes

Early Prediction of Increased Arterial Stiffness in Patients with Chronic Inflammation: A 15-year Followup Study of 108 Patients with Rheumatoid Arthritis

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