YY/T 1249-2014Free prostate specific antigen quantitative labelling immunoassay kit (English PDF)

4.1 Appearance and physical examination

The kits shall be completed in components. The internal and external package shall be intact. The label shall be clear.

4.2 Linearity

Within the interval of 0.5 µg/L~10 µg/L, USE double logarithmic or other appropriate mathematical model for fitting. The linear correlation coefficient (r) of dose-response curve shall not be less than 0.9900.

4.3 Minimum detection limit

It shall not be higher than 0.20 µg/L.

4.4 Accuracy

Calibrator in the kit AND fPSA national (or international) standard materials with corresponding concentrations are tested at the same time. USE double logarithmic or other appropriate mathematical model for fitting.

4.5 Precision

4.5.1 Within-analysis precision

Coefficient of variation (CV) of measured results of control material of manual operation kit shall not be more than 15.0%; the coefficient of variation (CV) of measured results of control materials of full-automatic immune analysis system kit shall not be more than 8.0%.

4.6 The measured value of control materials

For the kit equipped with fixed-value control materials, its determination result shall be in the range specified by the kit.

4.7 Specificity

USE national (or international) standard materials of free prostate specific antigen taken AS the comparison materials. The determination result of national (or international) standard materials prostate specific antigen in this kit shall be consistent with its labelled ratio content.

4.8 Stability

4.8.1 Stability at the end of validity

The kit is preserved until the end of the validity under a stated condition. The measured results shall comply with provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1 and 4.6.

5.1 Appearance and physical examination

The visual inspection under the natural light shall be in compliance with the provisions of 4.1. The redissolving time of freeze-dried products is measured with timer.

5.2 Linearity

Dose - response curve linearity of the kit's calibrator shall be in compliance with the provisions of 4.4. For those kits not equipped with calibrator, USE fPSA national (or international) standard materials (or other high concentration sample); PREPARE the proper concentration points (generally no less than 5 points), according to the linear range specified by the kit instructions.

5.3 Minimum detection limit

Repeatedly TEST zero-calibrator (or diluent of sample) for not less than 10 times.

Calculate the average value (mean x) and standard deviation (SD) of reaction volume (A or RLU or CPS, etc.). SUBSTITUTE the reaction volume of (mean x + 2SD) into dose-response curve. Calculate the corresponding concentration value. It shall comply with provisions of 4.3.

5.5 Precision

5.5.1 Within-analysis precision

2 ~ 3 control materials are set up in different areas of dose-response curves. Within a same-analysis, repeatedly measure each control materials for not be less than 8 times.

The coefficient of variation (CV) of the measured results shall comply with provisions of 4.5.1.

5.6 The measured value of control materials

Control materials (usually 2-3) are set up in different areas of dose-response curves. The measured results of the kit shall comply with the provisions of 4.6.

5.7 Specificity

National (or international) standard materials of free prostate specific antigen (fPSA) AND national (or international) standard materials of prostate specific antigen (fPSA) are prepared to solutions with appropriate series of concentrations.

5.8 Stability

After the kit is preserved at conditions specified by provisions of 4.8.1, 4.8.2 or 4.8.3, MEASURE 4.1, 4.2, 4.3, 4.4, 4.5.1 and 4.6. The results shall comply with related provisions.

6.1 Marks, labels of outer package of kit

It shall contain at least the following contents. […]

6.2 Marks and labels of each component package of kit

It shall contain at least the following contents. […]

6.3 Instructions of reagent (kit)

It shall generally contain the following contents. […]

7.1 Packaging

The kit shall be packed according to the requirements of product enterprise, and satisfy the requirements of GB/T 191.

7.2 Transportation

Reagent (kit) shall be transported according to the requirements of manufacturing enterprise. […]