Quantitative Diagnostic Kit for Neonatal Glucose-6-Phosphate

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【INTENDED USE】

The Quantitative Diagnostic Kit for Neonatal Glucose-6-Phosphate Dehydrogenase(Fluorimetry) is intended for the quantitative determination of Glucose-6-Phosphate Dehydrogenase (G6PD) in dried blood spots (DBS) on filter paper collected from newborn's heel.

 

【ANALYTICAL PERFORMANCE CHARACTERISTICS】

1. Diagnosis Peformance

   1066 samples including 332 positive, 697 negative and 37 critical samples were inspected and takes Neonatal G6PD kit(Fluorometry) produced by PerkinElmer as compared reagent. The result shows the sensitivity(positive coincidence rate) is 99.4%, the specificity(negative coincidence rate) is 97.2%, the crude agreement is 97.3%, adjusted agreement is 88.6%, Youden’s index is 0.966 and Kappa value(P<0.05) is 0.944. Our kit has a fair coherence with the compared reagent according to Kappa analysis. The related coefficient value is 0.960(P=0.01) with compared kit according to the quantitative detection value.The result shows fair stability, accurate and reliable.

 

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 0.85 U/g Hb.

 

4. Specificity

   The testing value for hemoglobin (50g/L), bilirubin(685μmol/L), glutathione(2440μmol/L), ascorbic acid(150μmol/L) and bovine serum albumin(60g/L) shall not exceed 0.85U/gHb 5. Method comparison Maintain panel test for 1066 dry blood samples of concentration (0.1-6.7 U/g Hb) by using our test kit(Y value) and Neonatal G6PD Kit produced by PerkinElmer(X value). The coherence value of two kinds of kits as follows:   

   Y=0.807X+0.444  

 r=0.960(n=1066)