【INTENDED USE】

 The Quantitative Diagnostic Kit for Neonatal Phenylalanine (fluorimetry ) is intended for the quantitative determination of phenylalanine(Phe) in dried blood spots(DBS) on filter paper collected from newborn's heel.

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1.Precision

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

2. Sensitivity 　　　

   The detection limit does not exceed 0.75mg/dl

3. Anti-interference ability

  The test value of tyrosine(10 mg/dl), leucine(10 mg/dl), arginine(20 mg/dl) in the kit does not exceed 0.75 mg/dl. And Ispol(L-methionine, L-histidine, L-ornithine, L-proline, L-glutamine and L-isoleucine, every reagent is 20 mg/dl) does not exceed 0.75 mg/dl.