YY/T 1221-2013Cardiac troponin I (cTnI) diagnostic kit (colloidal gold method) (English PDF)

3.1 Colloid gold technique

A labeling technique that uses colloidal gold particles as a tracer or chromogenic substance for antigen-antibody reaction or other molecular detection.

3.2 Lowest detection limit

The lowest measured value in a sample that can be declared different from zero with a certain probability.

3.3 Analytical specificity

The measurement program only measures the ability to be measured.

3.5 Repeatability

Under the same measurement conditions, the consistency between the results obtained by consecutive multiple measurements on the same measured object.

4.1 Physical properties

4.1.1 Appearance

It shall meet the normal appearance requirements specified by the manufacturer.

4.2 Accuracy

Test the positive control materials of cardiac troponin I (cTnI), all the results shall be positive.

4.3 Repeatability

Take 10 pieces of test papers of the same batch number to test the positive control materials of cardiac troponin I (cTnI) with the same concentration; the reaction results shall be consistent, the color shall be uniform, and all shall be positive.

4.5 Lowest detection limit

Test the sensitivity control materials of the cardiac troponin I (cTnI), which shall be no higher than 1.0ng/mL.

4.6 Stability

Take the test papers of the same batch number and place them at 37°C for 20d. The result shall meet the requirements of 4.2~4.5.

5.1 Basis for result judgment (see Figure 1)

5.1.1 Positive. The color of the color band of the test line (T) is the same as or deeper than the control line (C).

5.2 Physical properties

5.2.1 Appearance

Randomly select 1 piece of test paper and visually observe it under natural light. It shall meet the requirements of 4.1.1.

5.3 Accuracy

Test the positive control materials of the cardiac troponin I (cTnI); operate according to the instruction manual; and the results shall meet the requirements of 4.2.

5.4 Repeatability

Test the positive control materials of the cardiac troponin I (cTnI) with the same concentration; operate according to the instruction manual; and the result shall meet the requirements of 4.3.

5.7 Stability

Take the test papers of the same batch number and place them at 37°C for 20d; and test according to the methods shown in 5.3 ~ 5.6. The result shall meet the requirements of 4.6.

6.1 Reagent (kit) inspection type

Reagent (kit) inspection is divided into exit-factory inspection and type inspection.

6.3 Type inspection

Type inspection items are all items; and each batch of products shall be all-item inspected according to this Standard. Type inspection shall be carried out in one of the following situations.

8.1 Packaging

8.1.1 The reagent may be transported at the room temperature for a short period of time. Corresponding protective measures shall be enhanced in Winter or Summer, avoid becoming icy or at high temperature for a long time.

8.2 Storage

8.2.1 The reagent shall be stored in the environment at 4°C~30°C; no freezing storage is allowed.

8.2.2 Avoid heavy stress during the storage period. […]