YY/T 1533-2017Automatic time-resolved fluorescence immunoassay analyzer (English PDF)

3.3.2 Precision of sample loading

If pipetting volume of >= 10 µL and < 50 µL, the precision of sample loading CV is <= 5%. If pipetting volume of >= 50 µL, the precision of sample loading CV is < 2%.

3.3.3 Contamination by sample loading needle

Carrying contamination rate is < 0.01%.

3.3.4 Residual amount of lotion

The residual amount of lotion is < 3 µL/hole.

3.4 Temperature accuracy and fluctuation

The temperature accuracy of the incubation chamber is within ±1.5 °C. The temperature fluctuation is within ±1.5 °C.

3.5 Repeatability of clinical test

The in-batch repeatability CV of the kit is <= 15%.

3.6 Environmental test requirements

It shall meet the requirements of the applicable clauses in GB/T 14710.

3.7 Electrical safety requirements

It shall meet the requirements of the applicable clauses in GB 4793.1, GB 4793.9, YY 0648.

3.8 Electromagnetic compatibility requirements

It shall meet the requirements of the applicable clauses of GB/T 18268.1 and GB/T 18268.26.

4.1 Appearance

Visual inspection with normal vision or corrected vision under natural light shall meet the requirements of 3.1. error of 10-10 mol/L europium standard solution.

4.2.5 Stability

After the analyzer is turned on and in a stable working state, take one set of 200 µL 10-10 mol/L europium standard solution to repeat the test 10 times.

Calculate the average value of the measurement results. Then re-start the machine after 4 h and 8 h to repeat the test 10 times; calculate the average value of the measurement result. Take the first measurement result as the reference value; calculate the relative offset (alpha, %) according to formula (2), which shall meet the requirements of 3.2.5. Wherein:

- The average of the measured values in the 4th and 8th hours;

- The average value of the initial measured value.

4.3 Sample loading and cleaning system

4.3.1 Sample loading accuracy

The following methods can be used for verification:

a) Take 12 clean microwell cups; use a calibrated analytical balance (accuracy is ±0.1 mg) to weigh each empty cup; record it as W0i (where i

b) Put the weighed empty cups into the first row of flat-bottomed microplates in turn; add 100 µL of 0.9% saline to the first row of micro-bottomed cups of flat-bottomed microplates; weigh each microwell cup and record it as W1i (where i = 1,..., 12);

c) Calculate the result of (W1i - W0i) and convert it to volume, which is the sample loading volume per hole;

d) Calculate the relative deviation between the actual sample loading volume per hole and the set sample loading volume, which is the sample addition accuracy and shall meet the requirements of 3.3.1.

Note: It can also be verified according to the test method provided by the manufacturer. formula (3) and shall meet the requirements of 3.3.3. Wherein: c - Concentration value of high concentration sample.

4.3.4 Residual volume of lotion

The following methods can be used for verification:

a) Take a clean microplate and use a calibrated ten-thousandth balance to weight it; record it as M1;

b) Put the weighed microplate on any path of plate washing platform; run the plate washing twice; soak it for 2 s;

c) Weigh the microplate after washing the plate and record it as M2;

d) Calculate the average value of the residual volume of each hole; convert it into volume, which is the residual volume of the washing solution and shall meet the requirements of 3.3.4.

4.4 Temperature accuracy and fluctuation

The following methods can be used for verification:

a) Put the temperature sensor probe of the thermometer (accuracy 0.1 °C) into any incubation chamber;

b) Set the temperature of the incubation chamber to be tested to 37 °C and run it continuously for 1 h with continuous shaking;

c) Record the temperature from the 16th minute; record once every 1 minute; record 10 times in a row;

d) Calculate the average value as well as the difference between the maximum and minimum temperatures in the chamber to be tested. The difference between the average value of the chamber temperature and the set temperature value is the temperature accuracy; the half of the difference between the maximum value and the minimum value of the chamber temperature is the temperature fluctuation. The result shall meet the requirements of 3.4.