YY/T 1667-2020Chlamydia pneumoniae IgG antibody detection kit (ELISA) (English PDF)

3.1 Appearance

Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be completeness and completeness of each component of the kit Sex, trait requirements, etc.

3.2 Compliance rate of positive reference products

Use the Chlamydia pneumoniae IgG antibody test kit to test the national positive reference product or the standardized positive reference product, and the results should match Meet the requirements of the corresponding reference products.

3.3 Compliance rate of negative reference products

Use the Chlamydia pneumoniae IgG antibody test kit to test the national negative reference product or the standardized negative reference product, and the results should match Meet the requirements of the corresponding reference products.

3.4 The lowest detection limit

Use the Chlamydia pneumoniae IgG antibody detection kit to test the national minimum detection limit reference product or the standardized minimum detection limit reference product The test results should meet the requirements of the corresponding reference products.

3.5 Repeatability

Use the Chlamydia pneumoniae IgG antibody test kit to test the national repetitive reference product or the standardized repetitive reference product, the result All should be positive, and the coefficient of variation of the signal value or the calculated value should not be higher than 10.0%.

3.6 Inter-assay precision

Use the Chlamydia pneumoniae IgG antibody test kit to test the national repetitive reference product or the standardized repetitive reference product, the result All should be positive, and the coefficient of variation of the signal value or calculated value should not be higher than 15.0%.

3.7 Stability

The validity period stability and thermal stability can be verified.

3.7.1 Stability of validity period

The manufacturer shall stipulate the validity period of the product. Take the test kit within a certain period of time after the validity The test product compliance rate, minimum detection limit, repeatability, and the test results should meet the requirements of 3.2, 3.3, 3.4, and 3.5.

3.7.2 Thermal stability

Place the kit at 37°C for a certain period of time to detect the compliance rate of positive reference products, the compliance rate of negative reference products, the lowest detection limit, Repeatability, the test results should meet the requirements of 3.2, 3.3, 3.4, 3.5.

Note 1.Thermal stability cannot be used to derive the expiry date of the product, unless it is a derivation formula based on a large amount of stability research data.

Note 2.Generally, when the validity period is 1 year, choose products that do not exceed 1 month, when the validity period is half a year, choose products that do not exceed half a month, and so on. But Ruchao After the specified time, the product is acceptable if it meets the requirements.

Note 3.According to the product characteristics, the validity period stability or thermal stability can be selected for verification, but the selected method should be able to verify the stability of the product to ensure the validity period Product performance meets standard requirements.

4.1 Appearance

Visual inspection with normal vision or corrected vision under natural light should meet the requirements of 3.1.

4.2 Compliance rate of positive reference products

Use national positive reference materials or standardized positive reference materials for testing, and operate according to the product manual. The result should meet 3.2 Claim.

4.3 Compliance rate of negative reference products

Use the national negative reference product or the standardized negative reference product for testing, and operate according to the product manual. The result should meet 3.3 Claim.

4.4 Lowest detection limit

Use the national minimum detection limit reference product or the standardized minimum detection limit reference product for testing, operate according to the product manual, and the result should be Meet the requirements of 3.4.

4.5 Repeatability

Use the same batch number kit to test the national repetitive reference product or the standardized repetitive reference product, repeat the measurement 10 times, and calculate 10 measurements Determine the result signal value or result calculation value average (X) and standard deviation (s), calculate the coefficient of variation (CV) according to formula (1), and the result should meet 3.5 Claim.

4.6 Precision between batches

Use three batch numbers of kits to test national repetitive reference products or standardized repetitive reference products, and repeat the measurement 10 times for each batch number.

Calculate the average (X) and standard deviation (s) of the signal value or the calculated value of the result of 30 determinations, and calculate the coefficient of variation (CV) according to formula (1), and the result Should meet the requirements of 3.6.

4.7 Stability

The following methods can be used for verification.

4.7.1 Stability of validity period

Take the kit for a certain period of time after the expiration date, operate according to the instructions, and test according to 3.2, 3.3, 3.4, 3.5, and the test results should meet

4.7.2 Thermal stability

Place the kit at 37°C for a certain period of time, operate according to the instructions, and test according to 3.2, 3.3, 3.4, 3.5, and test results Should meet the requirements of 3.7.2.

6.1 Packaging

The packaging, storage and transportation pictorial signs should meet the requirements of GB/T 191. The packaging container should ensure good airtightness, integrity, no leakage and no damage.

6.2 Transportation

The kit should be transported as required by the manufacturer. During transportation, it should be moisture-proof, heavy objects should be prevented from being piled up, and direct sunlight, rain and snow should be avoided Dip to prevent contact with acid and alkali substances and prevent damage to the inner and outer packaging.

6.3 Storage

The kit should be stored under the conditions specified by the manufacturer. references [1] Medical device instructions and label management regulations, State Food and Drug Administration Order (No. 6), 2014.7.30 [2] Announcement on the issuance of guidelines for the preparation of instructions for in vitro diagnostic reagents, the State Food and Drug Administration (2014) Year 17)