YY/T 1523-2017Bicarbonate assay kit(PEPC enzymatic method) (English PDF)

3.1 Appearance

The appearance of kit shall meet the following requirements.

a) The components of kit shall be complete and intact; there is no liquid leakage;

b) The text and symbols of package label shall be clear.

3.2 Loading amount

It shall be no less than the marked value.

3.3 Reagent blank absorbance

certain period of time after the expiration date; test the reagent blank absorbance, analytical sensitivity, linear, repeatability, accuracy, which shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, 3.7.

3.8.3 Thermal stability test

Test the reagent blank absorbance, analytical sensitivity, linear, repeatability, accuracy, which shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, 3.7.

NOTE 1. Thermal stability cannot be used to derive the valid date of the product; unless it is from a derivation formula based on a large number of stability studies.

NOTE 2. Generally, a product with a valid period of 1 year and no more than 1 month is selected; the valid period shall be half a year; and so on. However, if it exceeds the specified time, when the product meets the requirements, it is also acceptable.

NOTE 3. According to the product characteristics, any combination of the methods specified in 3.8.2, 3.8.3 can be selected; but the selected method shall be able to verify the stability of the product to ensure that the product performance meets the standard requirements with the shelf life period.

4.1 Basic requirements of instrument

Spectrophotometer or biochemical analyzer, the wavelength range shall meet the requirements for reagent use; biochemical analyzer shall be equipped with thermostat (temperature value shall be within ±0.3°C of the setting value; fluctuation shall be no greater than ±0.2°C); the absorbance measurement resolution shall be 0.001 above.

4.2 Appearance

Take visual examination with normal or corrected visual acuity under natural light, the results shall meet the requirements of 3.1.

4.3 Loading amount

Use general measuring gauge to measure; it shall meet the requirements of 3.2.

4.4 Reagent blank absorbance

Use reagent kit to test the blank sample; record the absorbance value at the dominant wavelength of the reading point specified in the reagent kit parameters; which shall meet the requirements of 3.3.

NOTE. The blank sample can be pure water sample, saline, zero calibration solution, and the Xi - measurement concentration; T - calibrated concentration of reference material.

4.8.3 Recovery test

Add certain volume of standard solution or pure product to human sample (the volume ratio between standard solution and human sample shall not generate matrix change; after adding the standard solution, the total concentration of the sample shall be within the linear range of the kit); each concentration shall be test for 3 times; calculate the average value; calculate the recovery rate as per the Formula (5), which shall meet the requirements of 3.7b). Where. R - recovery rate; V - volume of the added standard solution; V0 - volume of human sample;

C - mean concentration of detection after human sample is added standard solution; C0 - mean concentration of detection of human sample; Cs - concentration of standard solution.

4.9 Stability

4.9.1 Shelf life stability

Take the sample after the expiration date, test as per the method specified in 4.4, 4.5, 4.6, 4.7.1, 4.8, which shall meet the requirements of 3.8.2.

4.9.2 Thermal stability test

Take the sample within the shelf life of product, according to the manufacturer claimed thermal stability conditions, test as per the methods specified in 4.4, 4.5, 4.6, 4.7.1, 4.8, which shall meet the requirements of 3.8.3.