QC Chart of Internal Quality Control (IQC)for Phe Quantitative Test

Internal Quality Control Program (IQC) for Neonatal Phe Screening Test

NS034

	CI		CII
QC Control Lot No.	TPC2101AG		TPC2101AH
ReagentKit	Guangzhou Fenghua Bionegineering CO. LTD.
Unit	mg/dL blood
Duration of the Analyzing	Month (2025/09)	CUM (2024/07/01~2025/09/30)	Month (2025/09)	CUM (2024/07/01~2025/09/30)
Runs (N)	12	132	12	132
Mean	2.7	2.9	9.5	10.2
SD	0.15	0.23	0.48	0.74
CV (%)	5.6	7.9	5.1	7.3
Target Value	2.9	2.9	10.7	10.7
Total Error (%)	18.0	15.9	21.3	19.2
TEa (%)	30	30	30	30
σ	4.1	3.8	3.7	3.5

Bias (%) = [ (│Mean - Target│) / Target ] x 100%
TE：Total Error(%) = Bias (%) + 2 × CV (%)
σ (Sigma) = [TEa% - Bias (%)] / CV (%)

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CI and CII SDI
QC Chart

Lot No.: TPC2101AG ; Reagent : Guangzhou Fenghua Bionegineering CO. LTD. ; Unit: mg/dL blood
Duration : 2024-07-01 to 2025-09-30 ; Target : 2.9 ; SD : 0.29 ( ●)

Lot No.: TPC2101AH ; Reagent : Guangzhou Fenghua Bionegineering CO. LTD. ; Unit: mg/dL blood
Duration : 2024-07-01 to 2025-09-30 ; Target : 10.7 ; SD : 1.07 ( □)

NS034

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CI SDI QC Chart

Lot No.: TPC2101AG ; Reagent : Guangzhou Fenghua Bionegineering CO. LTD. ; Unit : mg/dL blood
Duration : 2024-07-01 to 2025-09-30 ; Target : 2.9 ; SD : 0.29

NS034

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CII SDI QC Chart

Lot No.: TPC2101AH ; Reagent : Guangzhou Fenghua Bionegineering CO. LTD. ; Unit : mg/dL blood
Duration : 2024-07-01 to 2025-09-30 ; Target : 10.7 ; SD : 1.07

NS034

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NS006	NS007	NS008	NS009	NS010
NS011	NS012	NS013	NS014	NS015
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NS021	NS022	NS026	NS030	NS034
NS035	NS036	NS999

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Application

Peer Group Statistics (Table 1)

Month vs. Cumulative (Table 2)

QC Chart of Individual Lab

Supported by:
Preventive Medicine Foundation, Taipei, Taiwan
updated : 29 Mar, 2022

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