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• Cedex Bio HT Analyzer*, including accessories and disposables
• Standard laboratory equipment

• Calibrator C Bio*
• Control C Level 1 Bio*
• Control C Level 2 Bio*
• Control C Level 3 Bio*

", "Country": "XG", "Code": "Additional Equipment and Reagent Required", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "

Vial	Content	Composition
CA2B	Reagent cassette, 300 tests	Reagent 1 (R1): CAPSO, 557 mmol/L; pH 10.0; 5-nitro-5′-methyl-BAPTA (NM-BAPTA), 2 mmol/L; non-reactive surfactant; preservative.
Start Reagent (SR): EDTA, 7.5 mmol/L, pH 7.3; non-reactive surfactant; preservative.

", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "

Test definition	CA2B (745)	CA2D (790)
Measuring range      mmol/L      mg/L	Standard 0.2 – 5.0 8 – 200	High 2 – 50(1)  80 – 2,000(1)
Control level	C 1, 2, 3	C 3
Sample predilution	No	1:10
Measuring mode	Absorbance	Absorbance
Abs. calc. mode	Endpoint	Endpoint
Reaction mode	R1-S-SR	R1-S-SR
Reaction direction	Decrease	Decrease
Wavelength A/B	340/378 nm	340/378 nm
Calc. first/last	33/36	33/36
Unit	mmol/L, mg/L	mmol/L, mg/L

1. Up to 500 mmol/L (20 g/L) with automatic dilution.

Pipetting parameters	CA2B (745)	CA2D (790)
Water Diluent (Sample Predilution)(1)	No	20 μL sample + 180 μL water
R1	20 μL + 130 μL water	20 μL + 130 μL water
Sample (S)	3 μL + 30 μL water	3 μL + 30 μL water
SR	20 μL	20 μL
Total Volume	203 μL	203 μL

1.  Sample predilution is performed in a prior step, after which the reaction mix is prepared in the same way as the unmodified sample. 

Calibration
Calibrator	Calibrator C Bio (CAL C, 07-1110-1)
Calibration mode	Linear regression
Calibration interval	Each new lot, and if recalibration is required due to QC results.

• Control C Level 1 Bio (CONC1, 07-1112-8)
• Control C Level 2 Bio (CONC2, 07-1113-6)
• Control C Level 3 Bio (CONC3, 07-1114-4)

• Control C Level 3 Bio (CONC3, 07-1114-4)

Use the recommended control material. Other suitable control material can also be used.
Control intervals and acceptance limits should be adapted to each lab\u00adoratory's individual requirements. If values do not fall within the defined limits, corrective measures and recalibration are required.Conversion factors for calcium concentration:

• 1 mmol/L = 40.08 mg/L
• 1 mg/L = 0.02495 mmol/L

This method has been standardized against a primary standard material (SRM 956 c level 2).Representative performance data on Cedex Bio HT Analyzers are shown. Results obtained in individual laboratories may differ. Precision was determined in samples of three concentration levels. Coefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 21 days).

	Level 1	Level 2	Level 3
Mean	0.59 mmol/L (23.7 mg/L)	2.53 mmol/L (101 mg/L)	4.48 mmol/L (180 mg/L)
CV in-run [%]	2.9	1.8	1.8
CV inter-run [%]	3.5	1.9	2.1

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