Capillarys 2 Flex Piercing: Analytical performance assessment according to CLSI protocols for HbA1c quantification.

HbA1c is used for monitoring diabetic balance. In this paper we report an assessment of the analytical performances of Capillarys 2 Flex Piercing (C2FP) for HbA1c measurement using CE (Capillary Electrophoresis). CLSI (Clinical and Laboratory Standard Institute) protocols are used for the evaluation of apparatus performances: precision, linearity, method comparison, trueness and common interferences. HbA1c CVs average in intra-assay was 1.6% between run imprecision CV ranged from 0.1 to 1.8%. The linearity was demonstrated between 4.7 and 15.0%. The comparison study revealed that Bland Altman plot mean difference was equal to -0.03 (CI 95% (-0.05 to -0.0003)) and Passing-Bablok regression intercept was -0.05, CI95%(-0.13 -  -0.05); slope: 1.00, CI95%[1.00-1.01]. A strong correlation (r > 0.99) was proved. No significant effects of hemoglobin variants were seen with CE on HbA1c measurement. No problem related to sample-to-sample carry over was noted. No interferences of LA1c and cHb were observed. CE allowed quantification of HbA1c even at low level of total hemoglobin (40 g/L) in contrast to HPLC. Furthermore, this analyzer offered the opportunity of quantifying the HbA2 simultaneously with HbA1c . This evaluation showed that C2FP is a convenient system for the control of diabetes and the detection of hemoglobinopathies.

Evaluation of the first immunoassay for the semi-quantitative measurement of meprobamate in human whole blood or plasma using biochip array technology.

BACKGROUND: Meprobamate is a carbamate, and the main metabolite of carisoprodol. It is used as an anxiolytic agent. Overdose of both drugs produces intoxication that is often serious and sometimes life threatening. However there was until now no immunoassay for the diagnosis of this intoxication. METHODS: A chemiluminescent immunoassay for the semi-quantitative measurement of meprobamate in human blood and plasma has recently been developed, using the Evidence Investigator system (Randox®). In this study, the immunoassay was evaluated by testing drug-free (n=10) or spiked whole blood and plasma samples (n=70), and authentic post mortem whole blood samples from deceased patients in which meprobamate was present (n=38) or not (n=10). A previously validated gas chromatography-mass spectrometry (GC-MS) method was used for confirmation and quantification. 97 psychoactive drugs including carisoprodol were analyzed for possible interference. RESULTS: With a cut-off at 0.5 mg/L, specificity, sensitivity and accuracy were 100%, 97.2% and 97.6%, respectively. All the untreated patients presented results under the cut-off. Meprobamate was not detected in three whole blood samples spiked with concentrations under the therapeutic range. In the authentic patients (n=48), there were no false-negative results. A good correlation was found between the immunoassay and GC-MS (r=0.90). Quantitative results of the immunoassay are approximately two-fold lower than GC-MS results. Only carisoprodol presented a cross-reactivity, 38±6.6% at 10 mg/L, and 26±4.8% at 100mg/L. CONCLUSION: The first meprobamate immunoassay has shown very good specificity, selectivity and accuracy, which allow its use in hospital clinical laboratories for rapid diagnosis of meprobamate (or carisoprodol) intoxications.