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

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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
µIU/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.

Basic Data

Standard ID	GB/T 18990-2008 (GB/T18990-2008)
Description (Translated English)	Luteinizing Hormone (LH) Test Strip (colloidal gold Immunochromatographic assay)
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	8,867
Date of Issue	2008-11-03
Date of Implementation	2009-10-01
Older Standard (superseded by this standard)	GB/T 18990.1-2003; GB/T 18990.2-2003; GB/T 18990.3-2003
Quoted Standard	GB/T 191
Regulation (derived from)	National Standard Approval Announcement 2008 No.18 (Total No.131)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the terms and definitions luteinizing hormone detection test strips, technical requirements, test methods, inspection and judgment, packaging, signs and instructions, transport and storage. This standard applies to the determination of women LH levels in urine by physical gold chromatography on immune theory to predict the time of ovulation, women of childbearing age for guidance to choose the best time to conceive or guidance rhythm of luteinizing hormone detection test (hereinafter referred to as paper).