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YY/T 1527-2017 (YY/T1527-2017)

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YY/T 1527-2017: PDF in English (YYT 1527-2017)
YY/T 1527-2017
YY
NATIONAL PHARMACEUTICAL INDUSTRY
STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
α/β-Thalassemia Gene Typing Detection Kit
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Designation, Classification and Composition ... 5
5 Requirements ... 5
6 Test Methods ... 6
7 Mark, Label and Use Instructions ... 8
8 Package, Transportation and Storage ... 8
Bibliography ... 9
α/β-Thalassemia Gene Typing Detection Kit
1 Scope
This Standard specifies the terms and definitions, designation, classification and
composition, requirements, test methods, mark, label and use instructions, package,
transportation and storage of α/β-thalassemia gene typing detection kit (hereinafter
referred to as “kit”).
This Standard is applicable to the detection kit for detecting peripheral whole blood
samples and pregnant amniotic fluid samples; the adopted technical methods include
real-time PCR fluorescent method, PCR-reverse dot hybridization method, fluorescent
PCR melting curve method, gene chip method, and gap PCR (gap-PCR) method, etc.
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 In Vitro Diagnostic Medical Devices - Information Supplied by the
Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 Thalassemia
It is also known as maritime anemia. It is a group of hereditary small cell hypochromic
hemolytic anemia; its common feature is that due to the defects in the globin gene, one
or several synthesis of globin peptide chains in hemoglobin is reduced or cannot be
synthesized; resulting in changes in the composition of hemoglobin; it is mostly
manifested clinically as chronic progressive hemolytic anemia.
detection range of the kit; both are negative.
5.4 Detection limit
Test with a national reference product or a standardized enterprise reference product
of no-more-than 25ng or 4000 copies of thalassemia genotype; the results are both
positive; conform to the corresponding genotype.
5.5 Repeatability
5.5.1 Fluorescent PCR method. it shall conform to the provisions of the coefficient of
variation (CV) of the Ct value of fluorescent PCR method shall not exceed 5.0%.
5.5.2 Fluorescent PCR melting curve method, gap PCR (gap-PCR) method. test with
the reference product with the same repeatability; the results are the same.
5.5.3 Membrane hybridization or gene chip method. test with the reference product
with the same repeatability; the array spots on the membrane strip or chip shall be
colored; the test results shall be the same; and the color development shall be uniform.
5.6 Nucleic acid extraction efficiency
Extract the minimum amount of peripheral whole blood, fetal amniotic fluid cells or
simulated solution specified by the kit; the concentration of nucleic acid shall be no
less than 10ng/µL.
NOTE. if the final amount of nucleic acid cannot be determined, it can only be tested with a
positive sample of thalassemia; both results are positive; and conform to the corresponding
genotype.
5.7 Stability
The manufacturer shall specify the period of the shelf life of product. Take the product
for a certain period of time before the expiration of valid date; test the accuracy,
specialty, detection limit, repeatability, nucleic acid extraction efficiency of the reagent;
the results shall meet the requirements of 5.2, 5.3, 5.4, 5.5 and 5.6.
6 Test Methods
6.1 Appearance
Take visual examination with normal or corrected visual acuity under natural light, the
results shall meet the requirements of 5.1.
6.2 Accuracy
......
 
(Above excerpt was released on 2018-08-22, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT1527-2017