Alternate site testing for HbA1c using the Primus CLC330 GHb analyzer.

Objective: To determine whether the Primus high-pressure liquid chromatography (HPLC) is suited to alternate site testing (AST) for HbA1c in a hospital diabetes outpatient clinic.Research Design and Methods: Patients were attending the clinic for routine management of their diabetes. A number of dia...

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Publicado en:Diabetes Care Vol. 20; no. 4; pp. 607 - 610
Autores principales: Phillipov, George, Charles, Peter, Beng, Clive, Phillips, Patrick J., Phillipov, G, Charles, P, Beng, C, Phillips, P J
Formato: research Journal Article
Publicado: American Diabetes Association Apr1997
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Apr1997
      vid: 20
      iid: 4
      pid: 1367
      pub: American Diabetes Association
      place: Arlington, Virginia
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        10.2337/diacare.20.4.607
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        atl: Alternate site testing for HbA1c using the Primus CLC330 GHb analyzer.
      aug:
        au:
          Phillipov, George
          Charles, Peter
          Beng, Clive
          Phillips, Patrick J.
          Phillipov, G
          Charles, P
          Beng, C
          Phillips, P J
        affil: Endocrine and Diabetes Service, The Queen Elizabeth Hospital, Woodville, Australia
      sug:
        subj:
          Diabetes Mellitus Blood
          Chromatography, High Pressure Liquid Equipment and Supplies
          Chromatography, Liquid Methods
          Chromatography, High Pressure Liquid Methods
          Human
          Chromatography, Ion Exchange Methods
          Sensitivity and Specificity
          Time Factors
          Reproducibility of Results
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Ferrans and Powers Quality of Life Index
      ab: Objective: To determine whether the Primus high-pressure liquid chromatography (HPLC) is suited to alternate site testing (AST) for HbA1c in a hospital diabetes outpatient clinic.Research Design and Methods: Patients were attending the clinic for routine management of their diabetes. A number of diabetic patients with uremia (n = 11) were also investigated. HbA1c levels were measured in the outpatient setting by the Primus HPLC and in a more limited study the DCA-2000 instrument using the new 6-min assay cartridge. HbA1c measurements were also performed with Pierce affinity minicolumns and a Bio-Rad Variant HPLC.Results: The Primus HPLC assay had low imprecision of 2.3, 1.6, and 1.0% for HbA1c levels of 4.7, 7.3, and 11.1%, respectively, and was not prone to interference by carbamylated hemoglobin as found for the ion-exchange Variant HPLC method. Method comparison studies showed that the bias and proportional error between the Pierce affinity minicolumn procedure (standardized with respect to an external quality control program) and the Primus HPLC (Y) was -0.4 and 1.2% respectively (n = 32). Similarly the bias and proportional error between the Primus and DCA-2000 methods was 0.7 and -2.5%. The Primus was shown to give falsely elevated HbA1c concentrations if the time between sequential injections was > 28 min.Conclusions: The Primus HPLC has a decided advantage over specialty AST instruments, like the DCA-2000, in not only meeting AST requirements but also allowing rapid automated batch processing of all laboratory HbA1c samples.
      pubtype: Academic Journal
      doctype:
        research
        Journal Article
      ougenre: Article
    language: English
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