QC Chart of Internal Quality Control (IQC)for 17-OHP Quantitative Test

Internal Quality Control Program (IQC) for Neonatal 17-OHP Screening Test

NS034

	CI		CII
QC Control Lot No.	TPC2101AG		TPC2101AH
ReagentKit	Guangzhou Fenghua Bionegineering CO. LTD.
Unit	nmol/L blood
Duration of the Analyzing	Month (2025/11)	CUM (2024/07/01~2025/11/30)	Month (2025/11)	CUM (2024/07/01~2025/11/30)
Runs (N)	3	119	3	119
Mean	39.0	47.3	134.4	154.1
SD	5.87	5.09	2.23	13.51
CV (%)	15.1	10.8	1.7	8.8
Target Value	42.0	42.0	133.6	133.6
Total Error (%)	37.2	34.1	3.9	32.9
TEa (%)	20	20	20	20
σ	0.9	0.7	>6	0.5

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: nmol/L blood
Duration : 2024-07-01 to 2025-11-30 ; Target : 42.0 ; SD : 3.60 ( ●)

Lot No.: TPC2101AH ; Reagent : Guangzhou Fenghua Bionegineering CO. LTD. ; Unit: nmol/L blood
Duration : 2024-07-01 to 2025-11-30 ; Target : 133.6 ; SD : 12.20 ( □)

NS034

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CI SDI QC Chart

Lot No.: TPC2101AG ; Reagent : Guangzhou Fenghua Bionegineering CO. LTD. ; Unit : nmol/L blood
Duration : 2024-07-01 to 2025-11-30 ; Target : 42.0 ; SD : 3.60

NS034

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CII SDI QC Chart

Lot No.: TPC2101AH ; Reagent : Guangzhou Fenghua Bionegineering CO. LTD. ; Unit : nmol/L blood
Duration : 2024-07-01 to 2025-11-30 ; Target : 133.6 ; SD : 12.20

NS034

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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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