YY/T 1527-2017alpha/beta-Thalassemia gene typing detection kit (English PDF)
α/β-地中海贫血基因分型检测试剂盒
This is a limited preview
Buy now to download the full PDF (24 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1527-2017 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1527-2017 is the English-translated version of α/β-地中海贫血基因分型检测试剂盒.
YY/T 1527-2017 is the Chinese pharmaceutical industry standard for kits that type the genes of alpha- and beta-thalassaemia.
It gives the terms and definitions, the designation, the classification and composition, the requirements, the test methods, the marks, labels and instructions for use and the rules for packaging, transport and storage, covering the mutations and deletions the kit must detect, the agreement of the genotypes with reference materials, the detection limit in terms of DNA input, the specificity, the repeatability and the stability. Issued on 28 March 2017, it has applied since 1 April 2018.
Found what you need?
Document preview — YY/T 1527-2017
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Terms and Definitions4
- 4 Designation, Classification and Composition5
- 5 Requirements5
- 6 Test Methods6
- 7 Mark, Label and Use Instructions8
- 8 Package, Transportation and Storage8
- Bibliography9
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 alpha/beta-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
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 Requirements
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1527-2017
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
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
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1527-2017
$75.00