Universal Therapeutics Diagnostics Launches Que Sarah, Sarah 1 Step Pregnancy Test Cassette and Test Pen
Kuala Lumpur, Malaysia, 3 July 2023 – Universal Therapeutics Diagnostics, a leading medical device manufacturer based in Malaysia, is proud to announce the release of two pregnancy test kits. The Que Sarah, Sarah 1 Step Pregnancy Test Cassette and Que Sarah, Sarah 1 Step Pregnancy Test Pen have been meticulously designed to provide accurate and reliable results, offering women a convenient and effective means of early pregnancy detection in the comfort of their own homes.
Innovative Diagnostic Formats
The Que Sarah, Sarah 1 Step Pregnancy Test Cassette is an intuitive and self-performing immunoassay that enables the qualitative determination of human chorionic gonadotropin (HCG) hormone in urine. By leveraging advanced technology, this test kit offers early detection of pregnancy with exceptional accuracy. The cassette format ensures user-friendly handling and clear result interpretation, empowering women to monitor their reproductive health discreetly and confidently.
Complementing the cassette format, the Que Sarah, Sarah 1 Step Pregnancy Test Pen provides women with an alternative option for early pregnancy testing. Featuring a sleek and compact design, this pen-style test kit offers convenience and discretion. With a simple urine application, users can easily determine their pregnancy status through the pen's intuitive result display. The test pen is specifically designed to cater to the modern lifestyle, ensuring ease of use and reliability without compromising accuracy.
Performance and Technical Specifications
Que Sarah, Sarah 1 Step Pregnancy Test Pen is accurate when used correctly. The device is designed for the qualitative determination of human chorionic gonadotropin (HCG) hormone in urine for early detection of pregnancy. Below are the key performance metrics:
| Metric | Value |
| Sensitivity | 99.9% (98.7%-100%) |
| Specificity | 99.9% (99.2%-100%) |
| Result Time | Within 5 minutes |
| Detection Threshold | Higher than 25 mIU/ml |
Que Sarah, Sarah 1 Step Pregnancy Test Pen can be use at any time of the day, with no variable result observed. It is able to detect 99.9% of positive results when tested from the first day after missed period.
Quality Standards and Regulatory Compliance
Certified with the ISO13485:2016 Quality Management System (QMS), Universal Therapeutics Diagnostics upholds the highest standards of product quality and safety. This certification underscores the company's commitment to delivering exceptional healthcare solutions to women worldwide. Both the Que Sarah, Sarah 1 Step Pregnancy Test Cassette and the Que Sarah, Sarah 1 Step Pregnancy Test Pen have obtained the necessary licensing from the Medical Device Authority (MDA) of the Ministry of Health Malaysia.
Product compliance and manufacturing highlights include:
- ISO 13485:2016 QMS certification
- MDA approved IVDB1853123-117052
- Made in Malaysia
- Cost-Effective: Offers a budget-friendly way to determine pregnancy status at home, eliminating the need for costly clinic visits.
As a Malaysian manufacturer, Universal Therapeutics Diagnostics takes great pride in the production of these pregnancy test kits, which are entirely Made in Malaysia. Universal Therapeutics Diagnostics encourages women to take control of their reproductive health and experience the convenience and accuracy offered by these advanced pregnancy test kits.