GB/T 26124-2011In vitro diagnostic reagent(kit) for clinical chemistry (English PDF)

3.1 In Vitro Diagnostic Reagent

In vitro diagnostic reagent refers to the chemical, biological or immunological components, solutions or preparations that are expected to be used by the manufacturer as an in vitro diagnostic medical device.

3.2 Clinical Chemistry Reagent

Clinical chemistry reagent refers to an in vitro diagnostic reagent based on the principle of spectrophotometry used in the quantitative inspection of clinical chemistry items in medical laboratories.

3.3 Kit

Kit refers to a set of components packaged together to complete a specified in vitro diagnostic test.

3.4 Accuracy

Accuracy refers to the degree of consistency between a measured value and an acceptable reference value.

3.5 Reference Material

Reference material refers to a material or substance that has one or multiple sufficiently uniform and well-determined characteristics to calibrate measurement devices, evaluate measurement methods or assign values to materials.

3.6 Certified Reference Material; CRM

Certified reference material refers to a reference material with an attached certificate; one or multiple characteristic values are determined by an established traceability procedure, so that it can be traced to an accurate reproducible measurement unit representing the characteristic value. Each certified characteristic value is accompanied by the uncertainty of a given confidence level.

4.1 Naming

The product name of in vitro diagnostic reagents (kits) for clinical chemistry shall include the Chinese name of the corresponding test item, and if necessary, the English (abbreviated) name may be added.

4.2 Classification

The composition, specifications and detection principle of the reagents (kits) shall be described.

5.1 Appearance

The appearance shall comply with the normal appearance requirements specified by the manufacturer.

5.2 Net Weight

The net weight of liquid reagents shall be not less than the indicated value.

5.3 Reagent Blank

5.4 Analytical Sensitivity

When the reagents (kits) are used to test n units of tested object, the difference in absorbance ( A) or the change rate of absorbance ( A/min) shall comply with the range provided by the manufacturer.

5.5 Linearity Range

The analytical performance within the linearity range of the reagents (kits) shall comply with the following requirements. […]

5.6 Precision of Measurement

5.7 Accuracy

The accuracy of the reagents (kits) shall comply with the requirements specified by the manufacturer.

5.8 Stability

The following methods may be selected for the verification of stability.

6.1 Basic Requirements for Instruments

Spectrophotometer or biochemical analyzer. the wavelength range covers 340 nm to 700 nm. The biochemical analyzer shall be equipped with a constant-temperature device (precision ± 0.1 °C). The precision of absorbance measurement is above 0.001.

6.4 Reagent Blank

6.4.1 Use the designated blank samples to test the reagents (kits). At the main wavelength of the test, record the absorbance (A1) at the start of the test and the absorbance (A2) after about 5 min (t). The test result of A2 is the measured value of the […]

6.5 Analytical Sensitivity

Use samples with already-known concentration or activity to test the reagents (kits); record the absorbance change generated under the specified parameters of the reagents (kits). Convert it to the difference in absorbance ( A) of n units, or, the change rate of absorbance ( A/min) of n units, which shall comply with the requirements of 5.4.

6.6 Linearity Range

6.7 Precision of Measurement

6.7.1 Repeatability

Under repeatability conditions, use the control materials to test the reagents (kits); repeat the test for at least 10 times (n >= 10). Respectively calculate the average value ( x) and standard deviation (s) of the measured values. In accordance with Formula (1), calculate the coefficient of variation (CV), which shall comply with the requirements of 5.6.1.

6.7.2 Within-run difference between bottles

Use the control materials to respectively test 10 bottles with the same batch number.

In addition, calculate the average value ( x1) and standard deviation (s1) of the 10 measured values.

6.7.3 Between-run difference

Use the control materials to respectively test reagents (kits) with 3 different batch numbers. For each batch number, test 3 times. Respectively calculate the average value xi (i = 1, 2, 3) of the 3 tests of each batch. In accordance with Formula (4) and Formula (5), calculate the relative deviation (R), which shall comply with the requirements of 5.6.3.

6.9 Stability

The following methods may be selected for the verification of stability.

7.1 General Requirements

The markings, labels and instructions for use shall comply with the following requirements. […]

7.2 Markings and Labels of Outer Container

The markings and labels of the outer container shall include the following information.

7.3 Markings and Labels of Immediate Container

If the immediate container is also the outer container, then, the requirements of 7.2 also apply.

7.4 Instructions for Use

The instructions for use shall provide the following information.

8.1 Packaging

The packaging shall comply with the following requirements. […]

8.2 Transportation

Transport in accordance with the conditions specified in the contract.

8.3 Storage

Store in accordance with the specified conditions. […]