Transforming HIV Care: UT+ Diagnostics' Innovative 4th Gen HIV Test Approved by Medical Device Authority, Ministry of Health (Malaysia).
FOR IMMEDIATE RELEASE
20 May 2025
Kuala Lumpur, Malaysia
Kuala Lumpur, Malaysia –20 May 2025 – Universal Therapeutics Diagnostics Sdn Bhd, a leader in innovative medical diagnostic solutions is pleased to announce a significant research breakthrough with the successful approval of the “UT+ Diagnostics 4th Generation HIV 1/2 + p24 Test” by Medical Device Authority (MDA), Ministry of Health Malaysia.
This milestone underscores the company’s continuing commitment to providing healthcare professionals with advanced HIV diagnostics tools that enhance patient outcomes and support global efforts in combating HIV/AIDS prevention and early detection.
The medical device integrates next-generation immunoassay technology with the proprietary UT+ Diagnostics platform, enabling highly accurate detection of HIV-1/2 antibodies and HIV-1 p24 antigen.
The p24 antigen is a protein present in the HIV virus that emerges soon after infection, making it a critical biomarker for early HIV detection and clinical intervention. This substantially shortens the window period between infection and detection.
Key Benefits and Features:
Reduced Window Period: Detects HIV infections as early as 21 days, a significant improvement versus typical 90 day window period associated with 3rd generation HIV testing devices.
High Accuracy Across Multiple Sample Types: Demonstrates reliable HIV detection performance with blood, plasma, or serum, effectively reducing false positives and negatives.
Field-Appropriate and Cost-Effective: Engineered for diverse and remote HIV testing settings, the test is easy to administer and cost-effective, ideal for broad-scale HIV diagnostic screening.
Early Diagnostic Capability: The dual detection of HIV antibodies and p24 antigen allows for earlier medical intervention and improved patient outcomes.
Efficient Laboratory Integration: Designed for seamless integration into existing diagnostic workflows in hospitals, clinics, and laboratories.
Supports Enhanced Patient Care: Rapid and accurate HIV diagnosis facilitates timely patient management, significantly aiding public health initiatives by reducing further HIV transmission.
Technical Specifications:
1. HIV 1/2 Antibody Detection:
o Sensitivity: >99.9%
o Specificity: 99.9%
o Accuracy: 99.9%
2. HIV p24 Antigen Detection:
o Relative Sensitivity: 99.1%
o Relative Specificity: 99.3%
o Accuracy: 99.3%
"We are proud to announce this research breakthrough that equips healthcare providers with advanced tools for earlier HIV detection," said Dato’ Sri Samuel Chai, Chief Executive Officer of Universal Therapeutics Diagnostics. “Our UT+ Diagnostics 4th Generation HIV 1/2 + p24 Test represents our unwavering dedication to advancing healthcare and addressing critical global health challenges.”
About Universal Therapeutics Diagnostics
Universal Therapeutics Diagnostics is a subsidiary of Universal Therapeutics Group specialising in innovative healthcare solutions and medical diagnostics . Through continuous research and development, Universal Therapeutics Diagnostics provides healthcare authorities and professionals with accessible, cost-effective, and high-performance diagnostic tools to enhance patient care worldwide.
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Media Enquiries:
Josephine KIM (Miss)
Communications Manager
PR1@Universal-Therapeutics.com