YY/T 1713-2020Diagnostic kit for colloidal gold immunochromatographic assay (English PDF)

3.1 Qualitative examination

a set of operations that identify or classify substances based on their chemical or physical properties

3.2 Semiquantitative examination

essentially, it is a qualitative test that adds options for the degree of response (positive degree, dilution to obtain a positive result, or comparison with the color card); the reaction results can be presented using ordinal tables and so on Example. The examination result can be reported as "-" "±" "+" "++".

3.3 Quantitative examination a set of operations that measure

the amount or concentration of an analyte and express it in a digital value of the appropriate measurement unit [GB/T 29791.1-2013, definition A.3.45]

3.5 C5-c95 interval

the concentration range of the analyte near the cutoff can be considered that more than 95% of the examination results of the analyte outside this concentration range are negative (concentration< c5) or more than 95% are positive (concentration >c95)

3.6 Limit of detection

the measured value obtained from a given measurement program; for this value, given that the false positive probability of a certain component in the claimed substance is alpha, the false positive probability of the non-existent component is beta

3.8 Analytical specificity

the ability of the examination procedure to only examine or measure the presence of the measurand when there are other quantities in the sample [GB/T 29791.1-2013, definition A.2.6]

4.1 Diagnostic kit for qualitative examination

4.1.1 Appearance

Meet the normal appearance requirements specified by the manufacturer.

4.1.2 Net content (when applicable)

If the kit contains liquid components, the volume shall meet the following requirements.

4.1.3 Film strip width

The manufacturer shall specify the width of the film strip (lower limit or deviation).

The random test shall be no less than the manufacturer's claim.

4.1.6 Compliance rate of negative reference products (when applicable)

Separately examine different reference products/samples used to evaluate the negative coincidence rate of reagents once each. The examination results shall all be negative.

4.1.8 Analytical specificity (when applicable)

Examine the negative reference product/sample containing a certain concentration/level of cross-reactant 3 times. The examination result shall not be positive.

4.1.9 High dose hook effect (when applicable)

Examine the high concentration/level positive reference product/sample claimed by the manufacturer 3 times. There shall be no false negatives in the examination results.

4.1.10 Repeatability

Test the negative and weakly positive reference products/samples with the indicated concentration/level at least 10 times. The coincidence rate of negative and positive results shall not be less than 95%.

The repeatability concentration/level setting and result judgment shall follow the following principles.

4.2.6 Analytical specificity (when applicable)

Examine the negative reference product/sample containing a certain concentration/level of cross-reactant 3 times. The result shall not be positive.

4.2.7 High dose hook effect (when applicable)

Examine the high concentration/level positive reference product/sample claimed by the manufacturer 3 times. The result shall be no false negatives.

4.3 Diagnostic kit for quantitative examination

4.3.1 Appearance

Meet the normal appearance requirements specified by the manufacturer.

4.3.6 Accuracy

It can use one of the following methods to verify. The relative deviation method is preferred.

5.1 Diagnostic kit for qualitative examination

5.1.1 Appearance

Visually inspect with normal vision or corrected vision under natural light, which shall be in accordance with the requirements in 4.1.1.

5.1.5 Limit of detection

Respectively examine the reference product/sample of different gradients with the indicated concentration/level once each. The result shall meet the requirements of 4.1.5.

5.1.6 Negative coincidence rate (when applicable)

Respectively examine different reference products/samples used to evaluate the specificity of reagents once each. The result shall meet the requirements of 4.1.6.

5.1.7 Positive coincidence rate (when applicable)

Respectively examine different reference products/samples used to evaluate the sensitivity of reagents once each. The result shall meet the requirements of 4.1.7.

5.1.10 Repeatability

Examine the negative and weakly positive reference products/samples with the indicated concentration/level at least 10 times. The result shall meet the requirements of 4.1.10.

5.1.11 Batch-to-batch difference

Extract 3 batches of kits. Respectively examine each batch of weakly positive reference products/samples with indicated concentrations/levels at least 10 times. The result shall meet the requirements of 4.1.11.

5.2 Diagnostic kit for semiquantitative examination

5.2.1 Appearance

Visually inspect with normal vision or corrected vision under natural light, which shall meet the requirements in 4.1.1.

5.2.2 Net content (when applicable)

Use a universal measuring tool to measure the number of liquid reagents, which shall meet the requirements in 4.2.2.

5.2.8 Repeatability

Respectively examine the concentration/level of different levels of concentration reference products/samples at least 10 times each. The result shall meet the requirements of 4.2.8.

5.2.9 Batch-to-batch difference

Extract 3 batches of kits. Each batch shall be tested respectively at least 10 times for the reference product/sample with the indicated concentration/level. The result shall meet the requirements of 4.2.9.

5.2.10 Stability

5.2.10.1 Stability of validity period

The diagnostic kit is stored under the specified storage conditions until the end of the validity period. Examine according to 5.2.5, 5.2.6, 5.2.7, 5.2.8. The result shall meet the requirements of 4.2.10a).

5.3.8 Linear

Dilute high-value samples close to the upper limit of the linear interval to at least

5.3.12 Stability

5.3.12.1 Stability of validity period

The diagnostic kit is stored under the specified storage conditions until the end of the validity period. Examine according to 5.3.6, 5.3.7, 5.3.8, 5.3.9, 5.3.10. The result shall meet the requirements of 4.3.12a).

7.1 Packaging

The packaging shall meet the following requirements.

7.2 Transportation

Transport in accordance with the conditions stipulated in the contract.

7.3 Storage

Store in accordance with the conditions specified by the manufacturer.