YY/T 1155-2019Automatic luminescence immunoassay analyzer (English PDF)

3.1 Luminescence immunoassay

A method that combines a luminescent system with an immune response to detect antigens or antibodies.

3.3 Automatic luminescence immunoassay analyzer

A luminescence immunoassay analyzer by which all analytical processes including the injection of samples and reagents, the provision of the immune binding reaction environment, data measurement, result calculation and output are implemented automatically.

4.1 Accuracy and repeatability of sample addition

The minimum and maximum sample loading volumes and the minimum and maximum reagent loading volumes specified on the instrument shall be tested and shall comply with the requirements of Table 1.

4.3 Light detection device

4.3.1 Instrument noise

The manufacturer's specifications shall not be exceeded.

4.3.2 Linearity of luminescence values

In the range of no less than 3 luminescence value orders of magnitude, the linear correlation coefficient (r) shall be >=0.99.

4.4 Carryover

The carryover rate shall be <=10-5.For analyzers that can only report qualitative test results, negative samples cannot be tested as positive after high-concentration positive samples are tested.

4.5 Intra-batch precision of clinical items

Select at least one clinical item and conduct the intra-batch precision test using the calibrators and kits specified by the manufacturer. The intra-batch precision shall comply with the requirements of the corresponding national standards and industry standards.

4.6 Main functions of the analyzer

The analyzer shall have the following main functions.

4.7 Appearance

The appearance of the analyzer shall meet the following requirements.

4.8 Environmental test requirements

It shall meet the requirements of climate environment group I and mechanical environment group I in GB/T 14710.

4.9 Security requirements

It shall comply with the requirements of applicable clauses in GB 4793.1, GB 4793.6,

GB 4793.9, and YY 0648.

5.1 Normal working environment conditions

5.1.1 Power supply voltage. 220 V±22 V; 50 Hz±1 Hz;

5.2 Accuracy and repeatability of sample addition

There are two types of determination methods. colorimetry and weighing method. Manufacturers can choose either method.

5.2.1 Weighing method

The weighing method is carried out according to the following steps.

5.2.2 Colorimetry

The colorimetric method is carried out according to the following steps.

5.3 Accuracy and fluctuation of temperature control in the reaction zone

Place the probe of a temperature detector with a resolution of not less than 0.1 °C, or a calibrated special temperature measuring tool with the same accuracy provided by the analyzer manufacturer, at the location specified by the manufacturer.

5.4 Light detection device

5.4.1 Instrument noise

After the analyzer is turned on and in a stable working state, use a blank sample to test for 20 consecutive times, record the luminescence value of each test, calculate the arithmetic mean 𝐼 of the luminescence values, and calculate the instrument noise IB according to formula (5), which shall meet the requirements of 4.3.1.

5.4.2 Linearity of luminescence values

One of the following two methods can be chosen.

5.6 Intra-batch precision of clinical items

Using calibrators and kits for the clinical test item specified by the manufacturer, test the intra-batch precision in accordance with the corresponding national standards, industry standards, or test kit technical requirements, which shall comply with the provisions of 4.5.

5.7 Main functions of the analyzer

The verification is performed according to the instructions; the functions shall meet the requirements of 4.6.

5.8 Appearance

Visual inspection is carried out; the appearance shall comply with the requirements of 4.7.

5.9 Environmental test requirements

The test is carried out according to the method specified in GB/T 14710. The results shall meet the requirements of 4.8.

5.10 Security requirements

The test is carried out according to the methods specified in GB 4793.1, GB 4793.6,

GB 4793.9, and YY 0648, and the results shall meet the requirements of 4.9.

7.1 Packaging

The packaging of the analyzer shall comply with the following provisions.

7.2 Transportation

Transportation shall be carried out in accordance with the requirements specified by the manufacturer.

7.3 Storage

Storage shall be carried out in accordance with the manufacturer's instructions.