YY/T 1517-2017 English PDF (YYT1517-2017)

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YY/T 1517-2017: Detection kit for IgA antibody to epstein-barr viral capsid antigens
YY/T 1517-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Detection Kit for IgA Antibody
to Epstein-barr Viral Capsid Antigens
ISSUED ON. MAY 2, 2017
IMPLEMENTED ON. APRIL 1, 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 Test Methods ... 6 
5 Label and Instruction for Use ... 7 
6 Packaging, Transportation and Storage ... 7 
References ... 9 
Detection Kit for IgA Antibody
to Epstein-barr Viral Capsid Antigens
1 Scope
This Standard specifies the technical requirements, test methods, label, instruction for
use, packaging, transportation and storage of detection kit for IgA antibody to Epstein-
barr viral capsid antigens (hereinafter referred to as “detection kit”).
This Standard is applicable to detection kit that qualitatively detects IgA antibody to
Epstein-Barr viral capsid antigens in human serum/plasma in accordance with the
principle of enzyme linked immunosorbent assay, chemiluminescence and time-
resolved fluorescence.
2 Normative References
The following documents are indispensable to the application of this Standard. In terms
of references with a specified date, only versions with a specified date are applicable
to this Standard. The latest version (including all the modifications) of references
without a specified date is also applicable to this Standard.
GB/T 191 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
3.1 Appearance
Appearance shall comply with the following requirements.
a) The various components of detection kit shall be complete and intact; there
shall be no liquid leakage;
b) Chinese labels on the package shall be explicit; there shall be no abrasion.
3.2 Positive Reference Compliance Rate
National-level positive reference or standardized positive reference shall be adopted
for detection, and the result shall comply with corresponding requirements.
NOTE 3. In accordance with product characteristics, any combination of Method a) and
Method b) can be selected. However, the selected method shall be able to verify
products’ stability, which can guarantee that products’ performance can comply
with standard requirements within the validity.
4 Test Methods
4.1 Appearance
Conduct visual inspection with normal vision or corrected vision under the natural light;
the result shall comply with the requirement in 3.1.
4.2 Positive Reference Compliance Rate
National-level positive reference or standardized positive reference shall be adopted
for detection; operate in accordance with the instruction for use; the result shall comply
with the requirement in 3.2.
4.3 Negative Reference Compliance Rate
National-level negative reference or standardized negative reference shall be adopted
for detection; operate in accordance with the instruction for use; the result shall comply
with the requirement in 3.3.
4.4 Minimum Detection Limit
National-level minimum detection limit reference or standardized minimum detection
limit reference shall be adopted for detection; operate in accordance with the
instruction for use; the result shall comply with the requirement in 3.4.
4.5 Repeatability
Take the same batch of detection kit; national-level repeatability reference or
standardized repeatability reference shall be adopted for 10 repeated detection.
Calculate the average value and standard deviation of the 10 detections.
Calculate the coefficient of variation CV in accordance with Formula (1) below. The
result shall comply with the requirement in 3.5
Where.
CV---Coefficient of variation;
---Standard deviation;