Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study

Reference intervals for clinical laboratory parameters are important for assessing eligibility, toxicity grading and management of adverse events in clinical trials. Nonetheless, haematological and biochemical parameters used for clinical trials in sub-Saharan Africa are typically derived from industrialized countries, or from WHO references that are not region-specific. We set out to establish community reference values for haematological and biochemical parameters amongst children aged 4 weeks to 17 months in Kilifi, Kenya. We conducted a cross sectional study nested within phase II and III trials of RTS, S malaria vaccine candidate. We analysed 10 haematological and 2 biochemical parameters from 1,070 and 423 community children without illness prior to experimental vaccine administration. Statistical analysis followed Clinical and Laboratory Standards Institute EP28-A3c guidelines. 95% reference ranges and their respective 90% confidence intervals were determined using non-parametric methods. Findings were compared with published ranges from Tanzania, Europe and The United States. We determined the reference ranges within the following age partitions: 4 weeks to <6 months, 6 months to less than <12 months, and 12 months to 17 months for the haematological parameters; and 4 weeks to 17 months for the biochemical parameters. There were no gender differences for all haematological and biochemical parameters in all age groups. Hb, MCV and platelets 95% reference ranges in infants largely overlapped with those from United States or Europe, except for the lower limit for Hb, Hct and platelets (lower); and upper limit for platelets (higher) and haematocrit(lower). Community norms for common haematological and biochemical parameters differ from developed countries. This reaffirms the need in clinical trials for locally derived reference values to detect deviation from what is usual in typical children in low and middle income countries

Use of a blood gas analyzer and a laboratory autoanalyzer in routine practice to measure electrolytes in intensive care unit patients

<p>Abstract</p> <p>Background</p> <p>Electrolyte values are measured in most critically ill intensive care unit (ICU) patients using both an arterial blood gas analyzer (ABG) and a central laboratory auto-analyzer (AA). The aim of the present study was to investigate whether electrolyte levels assessed using an ABG and an AA were equivalent; data on sodium and potassium ion concentrations were examined.</p> <p>Methods</p> <p>We retrospectively studied patients hospitalized in the ICU between July and August 2011. Of 1,105 test samples, we identified 84 instances of simultaneous sampling of arterial and venous blood, where both Na⁺ and K⁺ levels were measured using a pHOx Stat Profile Plus L blood gas analyzer (Nova Biomedical, Waltham MA, USA) and a Roche Modular P autoanalyzer (Roche Diagnostics, Mannheim, Germany). Statistical measures employed to compare the data included Spearman's correlation coefficients, paired Student’s <it>t</it>-tests, Deming regression analysis, and Bland-Altman plots.</p> <p>Results</p> <p>The mean sodium concentration was 138.1 mmol/L (SD 10.2 mmol/L) using the ABG and 143.0 mmol/L (SD 10.5) using the AA (p < 0.001). The mean potassium level was 3.5 mmol/L (SD 0.9 mmol/L) using the ABG and 3.7 mmol/L (SD 1.0 mmol/L) using the AA (p < 0.001). The extent of inter-analyzer agreement was unacceptable for both K⁺ and Na⁺, with biases of 0.150-0.352 and −0.97-10.05 respectively; the associated correlation coefficients were 0.88 and 0.90.</p> <p>Conclusions</p> <p>We conclude that the ABG and AA do not yield equivalent Na⁺ and K⁺ data. Concordance between ABG and AA should be established prior to introduction of new ABG systems.</p

Primary focal segmental glomerular sclerosis in children:clinical course and prognosis

To review the clinical course and identify prognostic factors, we retrospectively analyzed 92 children with steroid-resistant primary focal segmental glomerulosclerosis (FSGS). The mean age of onset was 80.4+/-42.4 months. The mean follow-up duration was 98.2+/-63.3 months. Eighty-five patients presented with nephrotic syndrome and seven presented with asymptomatic proteinuria. Thirty-three patients were initial responders to steroid treatment (late non-responders) and 59 were initial nonresponders. At last follow-up, 36 patients (39.1%) were in complete remission, and 29 (31.5%) progressed to chronic renal failure (CRF). Renal survival rates at 5, 10, and 15 years were 84, 64, and 53%, respectively. By morphological classification, there were tip variants (6.1%), collapsing variants (10.6%), cellular variants (1.5%), perihilar variants (9.1%), and NOS (not otherwise specified, 72.7%). Among the variants, there were no significant differences in age of onset, degree of proteinuria, response to treatment, or progression to CRF. Poor prognostic factors for CRF included: asymptomatic proteinuria at presentation, initial renal insufficiency, higher segmental sclerosis (%), severe tubulointerstitial change, initial nonresponse, and absence of remission. In the multivariate analysis, an increase in the initial serum creatinine and resistance to treatment were independent risk factors for CRF. A more prolonged use of corticosteroid therapy and early introduction of cyclosporin A (CsA) may improve the prognosis for primary FSGS in patients with initial steroid nonresponsiveness