YY/T 1516-2017Prolactin quantitative labelling immunoassay kit (English PDF)

4.5.2 Between-run precision

Set 2~3 quality control products with different concentration in the dose-response curve range of kit, and between 3 different batches of products; the coefficient of variation (CV) of the test results shall be no higher than 15.0%.

4.6 Specificity

Test the human growth hormone (GH) sample with concentration of 200ng/mL; its test results shall be no higher than 20.0µIU/mL.

4.7 Stability

4.7.1 End-of-shelf-life stability

Store the kit under the specific condition until the end of shelf life; the test results shall conform to the provisions of 4.2, 4.3, 4.4, and 4.5.1.

4.7.2 Thermal stability

Place the kit for a certain period of time at 37°C; the test results shall conform to the provisions of 4.2, 4.3, 4.4, and 4.5.1.

4.7.3 Stability after redissolution of the freeze-dried reagent

Re-dissolve the freeze-dried components in the kit as per the specified conditions; place for a certain period of time under the conditions specified by the manufacturer; the test results shall conform to the provisions of 4.2, 4.3, 4.4, and 4.5.1.

NOTE 1. Generally, products with shelf life of 1 year shall select the products not exceeding 1 month; products with shelf life of half a year shall select the product not exceeding half a month; and so on. However, if the specified time is exceeded, the products are acceptable when they meet the requirements.

NOTE 2. Thermal stability cannot be used to derive the shelf life of products; unless using the derivation formula based on a large number of stability studies.

NOTE 3. According to the product characteristics, one of the above methods of 4.7.1 or 4.7.2 can be selected for verification; however, the selected method shall verify the product stability; so that ensure the product performance in the shelf life meets the standard requirements

NOTE 4. If the kit contains the freeze-dried standard products and the like components; and they shall be placed for certain period of time after redissolution; then it shall carryout the CV- coefficient of variation; s - standard deviation of 10 times test results; x􀴥 - average value of 10 times test results.

5.5.2 Between-run precision

Use the kits with three different batch number to repeat the test for 10 times against the quality control products with different concentration; calculate the average value (x) of the test results and standard deviation (s); calculate the coefficient of variation (CV) as per Formula (4); the results shall conform to the provisions of 4.5.2.

CV- coefficient of variation; s - standard deviation of 30 times test results; x􀴥 - average value of 30 times test results.

5.6 Specialty

Use the kit buffer system to prepare the specialty sample into the prescribed concentration; parallel determined for twice; its measurement results shall conform to the provision of 4.6.

5.7 Stability

After the kit is stored according to the conditions specified in 4.7, test as per the method stipulated in 5.2, 5.3, 5.4, 5.5.1; the results shall conform to the provisions of 4.7.

7.1 Package