YY/T 1516-2017 (YY/T1516-2017, YYT 1516-2017, YYT1516-2017)
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Prolactin quantitative labelling immunoassay kit
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YY/T 1516-2017
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Standards related to: YY/T 1516-2017
| Standard ID | YY/T 1516-2017 (YY/T1516-2017) | | Description (Translated English) | Prolactin quantitative labelling immunoassay kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 7,796 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | China Institute of Food and Drug test | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1516-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
YY/T 1516-2017
Prolactin Quantitative
Labelling Immunoassay Kit
Issued on. March 28, 2017 Implemented on. April 01, 2018
Issued by. China Food and Drug Administration
YY/T 1516-2017
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Classification ... 4
4 Requirements ... 5
5 Test Methods ... 7
6 Label and Use Instructions ... 9
7 Package, Transportation and Storage ... 9
Bibliography ... 11
YY/T 1516-2017
Prolactin Quantitative
Labelling Immunoassay Kit
1 Scope
This Standard specifies the requirements, test methods, label and use instructions,
package, transportation and storage of prolactin quantitative labelling immunoassay
kit.
This Standard is applicable to the prolactin quantitative determining kit based on the
principle of double antibody sandwich method.
This Standard is not applicable to the prolactin semi-quantitative determining reagent
(such as test paper strip, etc.) labelled by colloidal gold or other methods; neither the
various prolactin radioimmunoassay or immunoradiometric kits labelled by
radioisotopes such as 125I.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 191-2008 Packaging – Pictorial Marking for Handling of Goods
GB/T 29791.2-2013 In Vitro Diagnostic Medical Devices - Information Supplied by
the Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Classification
According to the different labelling methods, it can be divided into enzyme labelling,
(electro) chemiluminescence labelling, (time-resolved) fluorescent labelling; according
to different solid-phase carriers, it can be divided into microporous plate type, tube type,
magnetic particles, microspheres, and plastic beads, etc.; according to different
operation process, it can be divided into manual operation method and instrument
automatic operation method.
YY/T 1516-2017
curve of the kit; the coefficient of variation (CV) of the test results of manual test kit
shall be no higher than 10.0%; the coefficient of variation (CV) of the test results of the
automatic test kit shall be no higher than 8.0%.
4.5.2 Between-run precision
Set 2~3 quality control products with different concentration in the dose-response
curve range of kit, and between 3 different batches of products; the coefficient of
variation (CV) of the test results shall be no higher than 15.0%.
4.6 Specificity
Test the human growth hormone (GH) sample with concentration of 200ng/mL; its test
results shall be no higher than 20.0μIU/mL.
4.7 Stability
4.7.1 End-of-shelf-life stability
Store the kit under the specific condition until the end of shelf life; the test results shall
conform to the provisions of 4.2, 4.3, 4.4, and 4.5.1.
4.7.2 Thermal stability
Place the kit for a certain period of time at 37°C; the test results shall conform to the
provisions of 4.2, 4.3, 4.4, and 4.5.1.
4.7.3 Stability after redissolution of the freeze-dried reagent
Re-dissolve the freeze-dried components in the kit as per the specified conditions;
place for a certain period of time under the conditions specified by the manufacturer;
the test results shall conform to the provisions of 4.2, 4.3, 4.4, and 4.5.1.
NOTE 1. Generally, products with shelf life of 1 year shall select the products not exceeding 1
month; products with shelf life of half a year shall select the product not exceeding half a month;
and so on. However, if the specified time is exceeded, the products are acceptable when they
meet the requirements.
NOTE 2. Thermal stability cannot be used to derive the shelf life of products; unless using the
derivation formula based on a large number of stability studies.
NOTE 3. According to the product characteristics, one of the above methods of 4.7.1 or 4.7.2
can be selected for verification; however, the selected method shall verify the product stability;
so that ensure the product performance in the shelf life meets the standard requirements
NOTE 4. If the kit contains the freeze-dried standard products and the like components; and
they shall be placed for certain period of time after redissolution; then it shall carryout the
YY/T 1516-2017
CV- coefficient of variation;
s – standard deviation of 10 times test results;
𝑥 – average value of 10 times test results.
5.5.2 Between-run precision
Use the kits with three different batch number to repeat the test for 10 times against
the quality control products with different concentration; calculate the average value (𝑥̅)
of the test results and standard deviation (s); calculate the coefficient of variation (CV)
as per Formula (4); the results shall conform to the provisions of 4.5.2.
CV- coefficient of variation;
s – standard deviation of 30 times test results;
𝑥 – average value of 30 times test results.
5.6 Specialty
Use the kit buffer system to prepare the specialty sample into the prescribed
concentration; parallel determined for twice; its measurement results shall conform to
the provision of 4.6.
5.7 Stability
After the kit is stored according to the conditions specified in 4.7, test as per the method
stipulated in 5.2, 5.3, 5.4, 5.5.1; the results shall conform to the provisions of 4.7.
6 Label and Use Instructions
It shall conform to the provisions of GB/T 29791.2-2013.
7 Package, Transportation and Storage
7.1 Package
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