【INTENDED USE】

   The Quantitative Diagnostic Kit for Neonatal Thyroid Stimulating Hormone (TRFIA) is a Time-resolved Fluorescence Immunoassay (TRF) for the quantitative detection of hTSH in dried blood spots (DBS) on filter paper collected from newborn's heel.

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1. Diagnosis Peformance

   258 samples including 90 positive and 168 negative were inspected and takes Neonatal hTSH FEIA( fluorescence enzyme immunoassay) produced by Anilabsysterms as compared reagent. The result shows the sensitivity(positive coincidence rate) is 100%, specificity(negative coincidence rate) is 96.4% and total coincidence rate is 97.7%. There is no statistic difference between them.

2. Precision

    The intra and inter-assay coefficients of variation should not exceed 20.0%.

3. The lowest detection 　　

   The detection limit should not exceed 5.0 μU/ml.

4. Anti-interference ability

   The testing value for hLH(250 IU/L), hFSH(250 IU/L) and HCG(100000 IU/L) in the kit should not exceed 5.0 μU/ml, 5.0 μU/ml, 5.0 μU/ml.