Robust Reference Intervals for Serum Kappa and Lambda Free Light Chains from a Multi Centre Study Population from Hyderabad, India: Myeloma Diagnostic Implications.

The International Myeloma Working Group considers the serum free light chain (SFLC) assay to be an adjunct to traditional tests. Apart from the FLC ratio, the absolute values of individual free light chains also are gaining importance as they appear to be more relevant in certain clinical settings. Automated assays are available for their determination. As laboratories put new test systems into use catering to different disease populations, they are required by accreditation and certification bodies to verify or establish performance specifications, including reference intervals (RIs) representative of their population. Our aim was to establish local RIs for SFLC in a multicentre representative healthy population using a robust method. There was no significant relationship between SFLC levels and age, gender and creatinine levels. The 95% RI for κSFLC was 4.81 to 33.86mg/L, for ? SFLC was 5.19 to 23.67mg/L and for κ/?SFLC was 0.36 to 2.33, significantly higher than the values given by the manufacturer. The κ/? SFLC ratio at 2.23, covering 100% of the data, showed 72% sensitivity (95% CI=39.0 - 94.0), 100% specificity (95% CI=71.5 - 100.0), 100% PPV (95% CI=21.5 - 100.0), 95% NPV (95% CI=75.4 - 99.9), and 79% accuracy (95% CI=56.0 - 93.0). In the patient group, kit RI for κ /? SFLC ratio classified 45.5% (n=5) as positive vs 9.1% (n=1) positive by the study RI, while the kit RI for kappa FLC classified 90.9% (n=10) as positive vs 54.5% (n=6) , indicating increased probability of false positive test results with the kit RI when applied to our patient population. Appropriate and specific reference intervals and criteria values result in fewer false-positive and false-negative results which means fewer wrong or missed diagnoses.

Diagnosis of Non-ST-Elevation Acute Coronary Syndrome by the Measurement of Heart-Type Fatty Acid Binding Protein in Serum: A Prospective Case Control Study.

A prospective case control study was undertaken to evaluate the diagnostic performance of serum heart-type fatty acid binding protein (HFABP) in comparison to cardiac TnT and TnI in 33 patients admitted with chest pain, diagnosed as NSTE-ACS (non ST elevation acute coronary syndrome) and 22 healthy controls. Area under the receiver operating curve (AUC) was highest for H-FABP (AUC 0.79; 95% CI 0.66-0.89) versus cTnI (AUC 0.73; 95% CI 0.59-0.84) and cTnT (AUC 0.71; 95% CI 0.57-0.83). The H-FABP level above 6.5 ng/mL showed 56.7% (CI 37.4-74.5) sensitivity, 0.5 (95% CI 0.3-0.7) negative likelihood ratio (-LR), 100% (CI 84.6-100.0) specificity, and 100% (CI 79.4-100.0) positive predictive value (PPV), 62.9% (CI 44.9-78.5) negative predictive value (NPV). cTnI level above 0.009 µg/L had 40% (CI 22.7-59.4) sensitivity, 0.6 (95% CI 0.4-0.8) -LR, 100% (CI 84.6-100.0) specificity, 100% (CI 73.5-100.0) PPV, and 55% (CI 38.5-70.7) NPV. cTnT showed 46.7% (CI 28.3-65.7) sensitivity, 0.5 (95% CI 0.4-0.7) -LR, 100% (CI 84.6-100.0) specificity, 100% (CI 76.8-100.0) PPV, and 57.9% (CI 40.8-73.7) NPV at level above 9 µg/L. +LR were 12.5 (95% CI 1.8-86.8), 1.7 (95% CI 1.0-3.0), and 1.2 (95% CI 0.8-1.9) for H-FABP, cTnI, and cTnT respectively. In conclusion measurement of H-FABP is a valuable tool in the early diagnosis of patients with chest pain (6-8 hrs) and seems to be a preferred biomarker in the differential diagnosis of NSTE-ACS. More studies are needed to determine whether serum H-FABP further improves diagnostic performance.