Establishment of reference intervals for hematological parameters of adult population in the western region of Saudi Arabia.

BACKGROUND: Most of hematology laboratories in Saudi Arabia utilize the reference intervals (RIs) provided by instrument manufacturers. This study aimed to define RIs of hematological parameters for adult population in the western region of Saudi Arabia and to explore their specific features from an international perspective. METHOD: This study was conducted according to the harmonized protocol of IFCC Committee on RIs and Decision Limits. Blood samples collected from 409 healthy Saudi males and females adults were analyzed for complete blood count (CBC) by using Cell-Dyn Sapphire analyzer and for iron profile by using Architect analyzers. The needs for RIs partitioned by sex and age was based on standard deviation ratio (SDR) and/or bias ratio (BR). RIs were derived parametrically with/without application of the latent abnormal values exclusion method (LAVE). RESULTS: Based on thresholds of SDR≥0.4 and/or BR≥0.57, RIs were partitioned by sex for red-blood cell count, hemoglobin, hematocrit, red cell distribution width, erythrocyte sedimentation rate, iron, transferrin, ferritin, eosinophil, platelet, plateletcrit, etc. Partitioning by age was not necessary for any of the analytes. LAVE procedure caused appreciable changes in RI limits for most erythrocyte and iron parameters but not for leukocyte parameters. Comparable to other non-IFCC studies on CBC RIs, the RBC and hematocrit (Ht) ranges have shifted to a higher side in both genders. After applying the LAVE method, the male and female RIs for Hb were 4.56 to 6.22 ×106/µL and 3.94 to 5.25 ×106/µL respectively while RIs for Ht were 40.2 to 52.0% and 33.6 to 44.5% respectively. CONCLUSION: LAVE method contributed to reducing the influence of latent anemia in deriving RIs for erythrocyte related parameters. Using the up-to-date methods, the RIs of CBC determined specifically for Saudis will help to improve the interpretation of test results in medical decision making.

Assessment of Becton Dickinson Plain and Serum Separator Tubes in Measurement of 25-Hydroxyvitamin D3 (25OHD3) by HPLC and Immunoassay Methods.

BACKGROUND: The accuracy of 25-hydroxyvitamin D3 (25OHD3) measurement on specimens collected into serum separator tubes (SSTs) has been questioned because of possible interference by the gel. Possible interference was investigated in SSTs from Becton Dickinson (BD). DESIGN AND METHODS: Blood specimens were collected simultaneously from 50 normal subjects into plain tubes and SSTs. 25OHD3 was assayed on serum using high performance liquid chromatography (Chromsystems), and Architect (Abbott) and Liaison (Diasorin) immunoassays. RESULTS: There were no significant differences between 25OHD3 results (means ± SE, nmol/l) obtained from specimens collected into plain tubes and SSTs assayed by HPLC (39.0 ± 2.7 vs. 39.3 ± 2.7), Liaison (32.9 ± 2.2 vs. 32.8 ± 2.3), or Architect (43.1 ± 2.8 vs. 43.2 ± 2.8). In specimens collected into plain tubes and SSTs, 25OHD3 measurements by HPLC correlated significantly (P < 0.0001) with those from the Architect (r = 0.895, r = 0.908) and Liaison (r = 0.907, r = 0.913), respectively. CONCLUSIONS: The gel in SSTs (BD) does not interfere with the measurement of 25OHD3 by HPLC or common immunoassays. This important finding may enable clinical laboratories to make cost savings by using SSTs without concerns about inaccuracy.

Establishment of reference intervals of clinical chemistry analytes for the adult population in Saudi Arabia: a study conducted as a part of the IFCC global study on reference values.

BACKGROUND: This study is a part of the IFCC-global study to derive reference intervals (RIs) for 28 chemistry analytes in Saudis. METHOD: Healthy individuals (n=826) aged ≥18 years were recruited using the global study protocol. All specimens were measured using an Architect analyzer. RIs were derived by both parametric and non-parametric methods for comparative purpose. The need for secondary exclusion of reference values based on latent abnormal values exclusion (LAVE) method was examined. The magnitude of variation attributable to gender, ages and regions was calculated by the standard deviation ratio (SDR). Sources of variations: age, BMI, physical exercise and smoking levels were investigated by using the multiple regression analysis. RESULTS: SDRs for gender, age and regional differences were significant for 14, 8 and 2 analytes, respectively. BMI-related changes in test results were noted conspicuously for CRP. For some metabolic related parameters the ranges of RIs by non-parametric method were wider than by the parametric method and RIs derived using the LAVE method were significantly different than those without it. RIs were derived with and without gender partition (BMI, drugs and supplements were considered). CONCLUSIONS: RIs applicable to Saudis were established for the majority of chemistry analytes, whereas gender, regional and age RI partitioning was required for some analytes. The elevated upper limits of metabolic analytes reflects the existence of high prevalence of metabolic syndrome in Saudi population.

The relationship between glycosylated haemoglobin (HbA1c) and measures of insulin resistance across a range of glucose tolerance.

AIM: This study aimed to assess the correlation between HbA1c and insulin resistance as measured by a variety of different indices in subjects from across the glycaemic spectrum. METHODS: Subjects with normal glucose tolerance (NGT; n = 24), impaired fasting glucose (IFG; n = 12), impaired glucose tolerance (IGT; n = 12), and type 2 diabetes (DM; n = 13) were studied. All had specimens taken in the context of a standard oral glucose tolerance test at their first visit and had the insulin sensitivity parameter (Si) determined by frequently-sampled intravenous glucose tolerance test at a second visit. RESULTS: HbA1c was more strongly associated with Si in NGT (r = - 0.65) than in IFG (r = - 0.48). Compared to other indices of insulin resistance HbA1c has minimal overlap in values (0.0%) between NGT and subjects with type 2 diabetes. CONCLUSIONS: HbA1c can be used as a simple and reliable marker of insulin resistance in NGT adults with relatively high insulin sensitivity.