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GB/T 18990-2008 English PDF (GBT18990-2008)

GB/T 18990-2008 English PDF (GBT18990-2008)

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GB/T 18990-2008: Luteinizing Hormone (LH) Test Strip (colloidal gold Immunochromatographic assay)

This Standard specifies the terms and definitions, technical requirements, test methods, inspection and judgment, packaging, marks and operation instructions, transportation, and storage of luteinizing hormone test strip. This Standard applies to luteinizing hormone test strip (Hereinafter referred to as strip) for the determination of LH levels in urine of women by using the principle of colloidal gold immunochromatographic assay, so as to predict the time of ovulation. It guides women of childbearing age to choose the best time to conceive or guides the rhythm in safe period.
GB/T 18990-2008
GB
ICS 11.100
C 44
NATIONAL STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
Replacing GB/T 18990.1 ~ 18990.3-2003
Luteinizing hormone (LH) test strip
(Colloidal gold immunochromatographic assay)
ISSUED ON. NOVEMBER 3, 2008
IMPLEMENTED ON. OCTOBER 1, 2009
Issued by. General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China;
Standardization Administration Committee of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Technical requirements ... 5
5 Test methods ... 6
6 Inspection and determination ... 8
7 Packaging, marks, and operating instructions ... 9
8 Transportation and storage ... 10
Bibliography ... 11
Foreword
This Standard replaces GB/T 18990.1 ~ 18990.3-2003 Luteinizing Hormone (LH) Test Strip.
Compared with GB/T 18990.1 ~ 18990.3-2003, the main changes of this Standard are as follows.
?€? Integrate and revise the Part 1 - Part 3 of former standards as a single-standard; ?€? Modify the product name in accordance with relevant requirements in the Measures for the Administration of Registration of In-Vitro Diagnostic Reagents (Trial); ?€? Modify the terms and definitions;
?€? Add the technical requirements and test methods of "physical characteristics"; ?€? Modify the technical requirements and test methods of "cut-off";
?€? Delete the ?€?cross reaction with HCG?€? in the requirements of "specificity"; ?€? Modify the technical requirements and test methods of "repeatability"; ?€? Modify the technical requirements and test methods of "stability";
?€? Add the technical requirements and test methods of "difference between batches"; This Standard was proposed by the China Food and Drug Administration.
This Standard shall be under the jurisdiction of the China Clinical Laboratory Testing and In vitro Diagnostic Test System of Standardization Administration of China. Participating drafting organizations of this Standard. Kunming Yunda Bio-technology Co., Ltd., and Beijing Institute of Medical Device Testing.
Main drafters of this Standard. Ma Lan, Zhang Xinmei, Zhou Jianlei, Deng Shuangsheng, and Zhao Lisheng.
The previous versions replaced by this standard are as follows.
?€? GB/T 18990.1-2003, GB/T 18990.2-2003, GB/T 18990.3-2003.
Luteinizing hormone (LH) test strip
(Colloidal gold immunochromatographic assay)
1 Scope
This Standard specifies the terms and definitions, technical requirements, test methods, inspection and judgment, packaging, marks and operation instructions, transportation, and storage of luteinizing hormone test strip.
This Standard applies to luteinizing hormone test strip (Hereinafter referred to as strip) for the determination of LH levels in urine of women by using the principle of colloidal gold immunochromatographic assay, so as to predict the time of ovulation. It guides women of childbearing age to choose the best time to conceive or guides the rhythm in safe period. 2 Normative??references
The articles contained in the following documents have become part of this Standard when they are quoted herein. For the dated documents so quoted, all the modifications (excluding corrections) or revisions made thereafter shall not be applicable to this Standard. For the undated documents so quoted, the latest editions shall be applicable to this Standard.
GB/T 191 Packaging - Pictorial marking for handling of goods (GB/T 191-2008, ISO 780. 1997, MOD)
3 Terms??and??definitions
For the purpose of this Standard, the following terms and definitions apply. 3.1
Luteinizing hormone (LH) test strip
It refers to the test strip for detection of luteinizing hormone in the women?€?s urine by using the principle of colloidal gold immunochromatographic assay.
3.2
Cut-off
It refers to the limit value for determination of negative and positive detection results. 5.5.1 The cross reaction with FSH
TAKE the same batch of 3 test strips to determine the sample solution that contains 200 mIU/mL FSH standard substance. OPERATE in accordance with the manufacturer's instructions. Based on the determination results of 5.1, the 3 test strips shall comply with the requirements of 4.3.1.
5.5.2 The cross reaction with TSH
TAKE the same batch of 3 test strips to determine the sample solution that contains 250 ??IU/mL TSH standard substance. OPERATE in accordance with the manufacturer's instructions. Based on the determination results of 5.1, the 3 test strips shall comply with the requirements of 4.3.2.
5.6 Repeatability
USE LH sample solution with concentrations of 10 mIU / mL, 25 mIU/mL and 50 mIU/mL to respectively measure the same batch of test strips. MEASURE 10 pcs for each concentration. OPERATE in accordance to the manufacturer's instructions. The results shall comply with the requirements of 4.4.
5.7 Stability
TAKE the same batch of test strips. Place under the condition of 37??C for 20 days. DETECT the requirements in accordance with the methods shown in 5.3-5.6. The results shall comply with the requirements of 4.5.
5.8 Difference between batches
TAKE test strips from 3 batches, 10 pcs for each batch, total 30 pcs. OPERATE in accordance with the instructions?€? steps. 10 test strips of each batch are duplicate detected by LH sample solution with the concentration of 25 mIU/mL. The test results of 3 batches shall comply with the requirements of 4.6.
6 Inspection??and??determination
6.1 Batch
Products of the same-property, same-quality, continuously manufactured under the same-process condition, are deemed as a batch.
6.2 Amount of sampling
Randomly sample from the same batch. The minimum amount of sampling shall not be less than 3 times of the detection amount.
6.3 Inspection and determination rules
7.2 The transport package (outer package) shall be marked with.
a) Product name and product specifications;
b) Manufacturer?€?s name and address;
c) Production batch number or production date;
d) Product registration number;
e) Volume (Length??width??height);
f) "Moisture proof", "heat proof" and other words or signs shall comply with the relevant provisions of GB/T 191.
7.3 The operating instructions shall include the following contents.
a) Product name;
b) Packaging specifications;
c) Intended purpose and principles;
d) Operation steps (it shall indicates the valid duration within which the result must be read. If they are test strips, it shall indicate the duration to immerse in urine before taking out);
e) Result determination.
f) Precautions;
g) Storage conditions;
h) Name, address, contact information of the manufacturer;
i) Production license number;
j) Product registration number;
k) Product standard number.
8 Transportation??and??storage
The products shall be stored in accordance with the requirements specified in the product instructions.
The products shall be valid for at least 12 months.
Bibliography
[1] Medical equipment manuals, labeling and packaging label administrative regulations, State Food and Drug Administration
[2] IVD reagents instructions compilation guidelines, GSYJX [2007] No. 240. [3] Chinese Biological Product Standardization Committee, Regulation for China Biological Products (2000 Edition), Beijing. Chemical Industry Press, 2000. [4] IVD reagents registration and management methods (Trial), GSYJX [2007] No. 229. [5] Preparation normative for standards of Medical Instrument Registration Products, GYJX [2002] No. 407.

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