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YY/T 1652-2019 English PDF (YYT1652-2019)

YY/T 1652-2019 English PDF (YYT1652-2019)

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YY/T 1652-2019: General technical requirements of quality control materials for in vitro diagnostic reagents

This Standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation, and storage of quality control materials for in vitro diagnostic reagents. This Standard applies to quality control materials intended for the quality control of adapted reagents.
YY/T 1652-2019
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.100
C 44
General technical requirements of quality control
materials for in vitro diagnostic reagents
ISSUED ON: MAY 31, 2019
IMPLEMENTED ON: JUNE 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Requirements ... 6
5 Test methods ... 8
6 Labels and instructions for use ... 15
7 Packaging, transportation, and storage ... 15
Appendix A (Informative) Study principles for control material valuing, matrix effect, and biosafety ... 16
Bibliography ... 18
General technical requirements of quality control
materials for in vitro diagnostic reagents
1 Scope
This Standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation, and storage of quality control materials for in vitro diagnostic reagents.
This Standard applies to quality control materials intended for the quality control of adapted reagents.
This Standard does not apply to:
a) Quality control materials for correctness verification;
b) Quality control materials for external quality assessment;
c) Quality control materials for the detection of microorganisms,
immunohistochemistry, molecular pathology, morphology, etc.;
d) Except for the above circumstances, if still inapplicable, the manufacturer must provide a reason.
2 Normative references
The following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of
quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB/T 29791.1-2013 In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
GB/T 29791.2 In vitro diagnostic medical devices - Information supplied by 4 Requirements
4.1 Appearance
It shall comply with the manufacturer?€?s stated requirements such as status, packaging, and identification.
4.2 Packing volumes
The packing volumes of liquid quality control material are not less than the volumes indicated.
4.3 Intended result
The control material is measured on the claimed detection system. The result shall be in accordance with the manufacturer?€?s stated intended result.
4.4 Homogeneity
TAKE the control materials of a certain number (n???10) of minimum package units of the same batch number. The result shall meet the manufacturer?€?s stated homogeneity requirement.
4.5 Stability
4.5.1 Unsealing/redissolving stability
The manufacturer shall, in order of priority, select one of the following methods for verification:
a) It shall specify the stability period of the control material under the specified storage conditions after the first unsealing/redissolving. The difference between the detection result of control material at the end of the stability period and that of the newly-unsealed/redissolved control material is not significant.
b) It shall specify the stability period of the control material under the specified storage conditions after the first unsealing/redissolving. The relative deviation between the detection result of control material at the end of the stability period and that of the newly-unsealed/redissolved
control material shall meet the manufacturer?€?s stated range requirement. c) It shall specify the stability period of the control material under the specified storage conditions after the first unsealing/redissolving. Detection is performed at the end of the stability period. The result shall be in
accordance with the intended result claimed by the manufacturer.
a) The quality control material within the expiration date is detected
according to the manufacturer?€?s claimed thermal stability method. The
quality control material at the end of the thermal stability period is
simultaneously detected with the normally-stored quality control material. The relative deviation of the detection result shall be within the range claimed by the manufacturer.
b) The quality control material within the expiration date is detected
according to the manufacturer?€?s claimed thermal stability method. The
detection result at the end of the thermal stability period shall meet the claimed intended result.
Note 1: Numerical quality control materials such as those with acceptable intervals/values/measurement signal values are suitable for method a) or b). Note 2: Non-numerical quality control materials such as those with negative/positive results only and no measurement signal values are suitable for method b). Note 3: If the above methods are not applicable, the manufacturer must explain the reasons and provide applicable verification methods.
Note 4: Thermal stability cannot be used to derive product expiration date unless a derivation formula based on a large number of stability study data is used. Note 5: According to the product characteristics, different test methods may be selected. However, the selected method should be able to verify the product stability, to ensure that the product performance within the expiration date meets the standard requirements.
See Appendix A for related study principles.
5 Test methods
5.1 Appearance
Visual inspection by normal vision. It shall meet the requirements of 4.1. 5.2 Packing volumes
USE a universal measuring tool to measure 3 times. Each measurement result shall meet the requirements of 4.2.
5.3 Intended result
The control material is measured on the claimed detection system. The
measurement is repeated no less than 3 times. Each measurement result shall n1 - Number of measurements for newly-unsealed/redissolved quality
control material;
s1 - Standard deviation of the measurement of newly-
unsealed/redissolved quality control material;
n2 - Number of measurements for the quality control material at the end of unsealing/redissolving stability period;
s2 - Standard deviation of the measurement of the quality control material at the end of unsealing/redissolving stability period.
If the t< critical value t??(n1+n2-2) of the degree of freedom (n1+n2-2) of significance level ?? (usually ??=0.05), there is no significant difference between the two average values.
Note: In order to ensure the accuracy of the average and standard deviation, both n1 and n2 are ???6.
b) It shall specify the stability period of the control material under the specified storage conditions after the first unsealing/redissolving. TAKE the newly-unsealed/redissolved quality control material and the control material at the end of the stability period to detect at the same time. The measurement is repeated 3 times. The average values of the detection
results are recorded as X0 and X, respectively. According to the formula (17), calculate the relative deviation B of the result. The result shall meet the requirements of 4.5.1 b).
Where:
B - Relative deviation;
X - The average of the detection result at the end of the stability period; X0 - The average of the initial detection result after unsealing/redissolving. c) It shall specify the stability period of the control material under the specified storage conditions after the first unsealing/redissolving. TAKE the quality control material at the end of the stability period for detection. The
detection is repeated 3 times. Each detection result shall comply with the requirements of 4.5.1 c).
Appendix A
(Informative)
Study principles for control material valuing, matrix effect, and biosafety A.1 Valuing of quality control materials
For valued control materials, the manufacturer shall assign values to the control materials and describe the materials and methods used, including but not limited to the following:
a) The detection system used (detection method and instrument);
b) Number of laboratories, number of tests per laboratory, number of
repetitions, reagent batches, number of equipment, and duration of
assessment;
c) The statistical analysis method used;
d) The results of each analyte level, including coefficient of variation, standard deviation, and confidence interval.
A.2 Matrix effect
Ideally, the composition of quality control material shall be as close as possible to the composition of the human sample, thereby minimizing the effects of the matrix and correctly reflecting the detection value of the sample. In actual development, in order to reduce consumption, it is more convenient and safer to make some changes to the matrix. For example, animal or synthetic matrices are used to protect the experimenter from infectious pathogens; preservatives, stabilizers, antibacterial agents, and clarifying agents are also added to increase the ease of use and stability of control material; production processes (such as lyophilization or inactivation) can significantly alter the physical, chemical, and biological properties of control material. Despite the benefits of various matrices and additives, the difference between these and human
samples may result in the inability of the control material to fully reflect the detection performance of the human sample. Therefore, it is recommended that the manufacturer evaluate the matrix of the control material during the study process, add the analyte capable of covering the measurement range in parallel in the control material matrix and the human sample, and compare the results to determine deviations, precision differences, and stability differences, etc. of the control material matrix relative to the natural sample. If necessary, refer to the CLSI guidelines EP-14, EP-30 for assessment of matrix effect.

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