GA/T 477-2021 in English

VALID

Rapid test strips for human prostate specific antigen (PSA)

Issued on:2021-10-14
Implemented on:2022-05-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $70.00
$68.00

Standard No:	GA/T 477-2021
Document status:	VALID
Title in English:	Rapid test strips for human prostate specific antigen (PSA)
Title in Chinese:	人前列腺特异性抗原（PSA）金标检验试纸条
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2021-10-14
Implemented on:	2022-05-01
Superseding:	GA 477-2004 Rapid test strips for human PSA
Professional Classification:	GA-Security
Related Keywords:	rapid test strips test strips gold-labeled test strips specificity test test data
Related Topics:	psa antigen specificity psa standard How to detect specificity verification of specificity test strip How to verify specificity principle of specificity specificity analysis test standard test Specific band prostate Gold inspection antigenicity psa prostate free prostate specific antigen prostate specific antigen non-specific prostate specific antigen psa series specific label psa series note psa characteristics Antigen+ prostate psa total prostate specific antigen prostate specific antigen dna specificity specific antigen species-specific antigen nonspecific strip specific antigen Antigen a non-specific band total prostate specific antigen Special test paper gold label prostate antigen Antigen condition Antigen Antibody Conditions How is prostate specific antigen detected Prostate specific antigen two free prostate specific antigen Antigen condition Sulfur Specific Detector specific agglutinogen Pre-S1 Antibody and Pre-S2 Antibody GA/T 1773.2-2021 Anti-jo-1 antibody mixed test positive, single test negative GA T 1788.3-2021 Physical PropertiesPSA GA 1800.2—2021 ga/t1921-2021

Introduction

Background of Standard Revision and Technological Evolution

The revised GA/T XXXX-XXXX standard replaces the 2004 version of GA 477 standard, mainly responding to the technical development needs of gold-labeled test strips. With the advancement of nano-gold labeling technology and monoclonal antibody purification technology, the new version of the standard will increase the detection sensitivity from the original 100ng/mL to ≥40,000 times semen dilution, and the specificity test will be newly verified by colostrum samples.

Comparison of core technical parameters

Indicators	2004 version	202X new version	Improvement range
Sensitivity	100ng/mL	40,000 times dilution	Equivalent concentration reduced by 60%
Specific samples	3 types of body fluids	4 types of body fluids	Added colostrum detection
Reaction time	Unlimited	10 minutes to judge	Time Standardization

Optimization of Key Experimental Methods

Improvement of Sensitivity Measurement

The new version of clause 5.2.1.3 requires the use of a five-level gradient dilution (16,000-40,000 times), which can more accurately determine the critical value compared to the old version of the three-level dilution. Typical cases show that in the detection of semen stains in rape cases, the new version of the test strips still maintains a 92% detection rate for five-year-old samples.

Enhanced Specificity Verification

New colostrum detection requirements (5.3.1.3) to solve the problem of cross-reaction of samples from lactating women. Test data from the Guangzhou Criminal Science Institute show that the new version of the test strips for vaginal secretions has a false positive rate reduced from 3.2% to 0.8%.

Implementation and application suggestions

Quality control management: It is recommended that laboratories establish a PSA standard concentration gradient plate (400-25ng/mL) and calibrate the sensitivity of the test strips every week
Sample processing: It is recommended to use PBS buffer instead of saline to dilute the corrupted samples, which can increase the detection rate by 6-8%
Result interpretation: Strictly follow the 10-minute interpretation time limit. Exceeding the time limit requires the note "tested under non-standard conditions"

Standard development trend

The next generation of standards may introduce quantum dot labeling technology, with an expected sensitivity of up to 100,000 times dilution. The current version has reserved an interface for digital interpretation, and it is recommended that manufacturers develop a matching image analysis algorithm module in advance.

More samples: QC/T 942-2021 YD/T 3934-2021 DL/T 5154-2012

Sample only — not a preview of GA/T 477-2021