Qvin's Q-Pad helps measure HbA1c using menstrual blood in diabetic patients

The US Food and Drug Administration has approved Qvin's Q-Pad A1c Test System for assessing hemoglobin A1c (HbA1c) levels in individuals with diabetes using menstrual blood. The kit is designed for individuals aged 18 and above to gather menstrual blood samples. It involves the use of the Q-Pad, an unscented menstrual pad equipped with a built-in blood collection strip called Q-Strip.

Traditional blood testing methods involve invasive procedures, conducted by healthcare professionals can be both time-consuming and costly. Not everyone has the resources for laboratory-based blood work. Interestingly, billions of individuals globally experience menstruation each month, yet until now, menstrual samples were not explored for diagnostic purposes. Qvin demonstrated the clinical relevance of menstrual blood for various essential biomarkers. Now, with the Q-Pad and A1c Test, individuals can gain health insights conveniently at home, as the FDA clearance for at-home sample collection and over-the-counter distribution underscores the safety and simplicity of Q-Pad technology.

The FDA clearance was granted based on a clinical validation study involving 198 participants who used the Q-Pad Kit to collect samples sent to the lab by mail. Reference samples were obtained through venous blood draws. The analysis revealed that the Q-Pad test system's clinical performance in measuring HbA1c was comparable to traditional blood testing. Additionally, a usability study with 40 women with diabetes was conducted. The participants followed instructions for sample collection and mailed it to Qvin labs. A questionnaire on the Q-Pad Kit's use was completed that showed 97.5% successfully collected a sample resulting in a valid HbA1c result.

The setup comprises the Q-Pad Kit and the Q-Pad A1c Test. Each kit contains 2 Q-Pads, a sample container for return, and a prepaid mailing pouch. The Q-Pad is recommended for use on menstrual cycle days 2 through 4. After gathering an ample menstrual sample, the detachable collection strips are stored in the container and sent back using the provided return mailer. The results are delivered through the HIPAA-compliant Qvin app within 5 to 10 days post-shipping.

In summary, Qvin's recent FDA-approved menstrual blood health test marks the start of significant advancements in women's health. This milestone not only streamlines regular testing but also reallocates resources for enhanced care.

Reference:

K231465 trade/device name: Q-pad test system regulation number: 21 CFR 864.7470 regulation name: Glycosylated hemoglobin assay regulatory class: Class II product code: LCP, QZG. (2023). Fda.gov. Q-Pad Test System Summary. Accessed January 15, 2024.