ABSTRACT
Background: Undiagnosed thyroid disease is a common problem with significant public health implications. This is especially true during pregnancy, when the health of the mother and child can be adversely affected by abnormal thyroid function. Measurement of thyroid stimulating hormone (TSH) and antibodies to thyroid peroxidase (TPO-Ab) are two important ways to assess maternal thyroid status.Objective: The purpose of our evaluation was to determine the prevalence of abnormal thyroid function by testing a population of pregnant women at the Obstetric Clinic, University Malaya Medical Center, Malaysia.Method: We assayed serum samples (n= 609) of pregnant partum women (age range 20-45) on the Abbott AxSYM platform using a 3rd generation TSH assay and TPO-Ab. Results outside the manufacturer’s reference range (TSH= 0.47-4.64 μIU/mL; TPO Ab \< 12 IU/mL) were considered to be abnormal.Result: Overall prevalence for an abnormal test result was 21.3%. Across the different age groups, the average prevalence for an abnormal result was TSH=10.3% and TPO-Ab=10.8%. If, as in the NACB thyroid testing guidelines, a more narrow TSH reference range (0.4-2.5 μIU/mL) was applied to our data, the prevalence of abnormal TSH results increased to 14.9%.Conclusion: Our data show a high prevalence of abnormal thyroid function in this population, and suggest that routine screening of pregnant women for thyroid dysfunction may be appropriate in addition to routine prenatal care.
ABSTRACT
Background: The current clinical dilemma of diabetes mellitus is prevention of micro- and macrovascular complications. These complications are directly linked to the degree of hyperglycaemia in diabetics. For long-term control of the glycaemic state, measurement of glycohaemoglobin in blood is essential, and glycohaemoglobin harmonization is encouraged for significant inter-laboratory variability. Objectives: To evaluate the performance of plasma glycosylated hemoglobin (HbA1c) assay on Primus PDQ and Bio-Rad D10 analyzers with respect to imprecision against the HbA1c goal, recovery and correlation to the HbA1c test on Cobas Integra 800 automated analyzer. Methods: PDQ employs high performance liquid chromotography (HPLC) boronate affinity chromatography. D10 uses HPLC cation-exchange chromatography. Cobas Integra 800 uses an immunoturbidimetric method. Imprecision studies were performed using patient samples and commercial control sera. Each sample was assayed 20 times and run every morning and afternoon for 5 consecutive days to evaluate between-run data. Recovery was assessed using a patient’s sample with low HbA1c level, admixed with another sample containing high HbA1c level. Comparison was made using 60 patient samples on PDQ and D10 using Cobas Integra 800 as the reference system. Ten venous samples from each group of patients with thalassaemia and uraemia were assayed for HbA1c on Cobas Integra 800, PDQ and D10. Results: The within-run coefficients of variation (CVs) on patient samples were 0.5% and 0.6% for PDQ and 1.1% and 1.3% for D10. The between-run CVs were 1.0% and 0.8% for PDQ and 0.3% and 1.2% for D10. PDQ yielded CVs of 1.1% and 0.7% for level 1 (normal) and level 2(abnormal) controls respectively while D10 demonstrated CVs of 0.5% for each level of controls. The between-run CVs for normal and abnormal controls were 1.7% and 0.8% respectively for PDQ, and 1.0% and 0.7% respectively for D10. Mean recovery for PDQ and D10 were 99.7% and 101.7% respectively. Both PDQ and D10 correlated well with Cobas Integra 800 [Cobas800]. HbA1c method by PDQ correlated well with that by D10. Conclusion: Both the HPLC systems demonstrated acceptable data, good recovery and are comparable with our current operating system (Cobas Integra 800). Both these systems appear to be satisfactory analytical alternatives to the Cobas Integra 800.