YY/T 1304.2-2015Detection system of time-resolved fluoroimmunoassay - Part 2: Quantitative reagent(kit) for time-resolved fluoroimmunoassay (English PDF)

3.1 Time-resolved fluoroimmunoassay; TRFIA

The analytical techniques which combine time-resolved fluorescence and immunoassay, use rare earth ions and their chelates as tracers, to label antigens or antibodies which undergo a series of immunological reactions with the analyte, to determine the fluorescence intensity of the final product, thereby obtaining the concentration of the analyte.

Note 2: When there is a certified reference substance (including national reference substance or international reference substance) in the test substance, use the item a) for testing.

Note 3: When there is no certified reference substance (including national reference substance or international reference substance) in the test substance, use the item b) for testing.

4.7 Specificity

It shall specify the specificity requirements.

4.8 Stability

The following methods can be selected for detection:

a) Expiration date stability: The manufacturer shall specify the expiration date of the kit. Take a batch of kits within a certain period of time after the expiration date, to test the items 4.2 ~ 4.4, which shall meet the corresponding requirements.

b) Thermal stability: After placing a batch of kits within the validity period at 37 °C for 7 days, test the items 4.2 ~ 4.4, which shall meet the corresponding requirements.

Note 1: According to product characteristics, any combination of a) and b) methods can be selected, but the selected method shall be able to verify the stability of the product, to ensure that the product performance meets the corresponding requirements within the valid period.

Note 2: In general, when the validity period of the kit is specified as 12 months, it should select the kit with an expiration period of not more than 1 month for stability test; when the validity period of the kit is specified as 6 months, it should select the kit with an expiration period of not more than half a month for stability test; and so on. However, it may also use the expiration date verified in the stability report provided by the manufacturer.

Note 3: Thermal stability cannot be used to derive the expiration date of the kit, unless a derivation formula based on a large amount of stability study data is used. CV - Coefficient of variation; SD - Standard deviation;

- Average value.

5.5 Differences between batches

Use 3 batches of reagents (kits) to test the same sample, respectively; repeat 10 tests for each. Calculate the average value and the standard deviation SD of the 30 measured concentration values. According to equation (1), obtain the coefficient of variation CV. The results shall meet the requirements of 4.5.

5.6 Accuracy

One of the following methods can be selected for accuracy:

a) Use a certain concentration of certified reference material as a sample.

Perform the testing according to the steps in the instructions. After 3 measurements, the result is recorded as Mn; the relative deviation Bn is calculated according to equation (2). If the three results all meet the requirements, it is judged as qualified. If the result is of two or more than two tests fail to meet requirements, it is judged as unqualified. If one of the results does not meet the requirements, the test shall be repeated 20 times in succession, meanwhile the relative deviation shall be calculated according to equation (2), respectively. If the results of more than or equal to 19 tests comply with requirements, the accuracy shall meet the requirements.

Where: Bn - Relative deviation (n = 1, 2, 3,..., 20); Mn - Measured value (n = 1, 2, 3,..., 20); T - Theoretical value.

b) Add a high level of analyte A with a known concentration to a low concentration of serum B (or other body fluid components). The volume ratio between the added analyte A and serum B (or other body fluid components) is not greater than 1:9; repeat the test 3 times; take the average value; calculate the recovery rate according to formula (3). The result shall meet the above requirements.

a) The name and address of the manufacturer;

b) Product name and specifications;

c) Storage conditions;

d) Production batch number and validity period;

e) Medical device registration certificate number and product standard number.

6.2 User instruction of the kit

It shall include at least the following:

a) Product name;

b) Packaging specifications;

c) Intended use;

d) Applicable instruments;

e) Testing principle;

f) Main components;

g) Storage conditions and expiration date;

h) Sample requirements;

i) Testing method;

j) Interpretation of testing results;

k) Reference value (reference range);

l) Limitations of Testing methods;

m) Product performance indicators;

n) Precautions;

o) Manufacturer's name and address;

p) License number of medical device manufacturer (only applicable to domestic medical device manufacturers);

q) Medical device registration certificate number; […]