Professional groups seek removal of test kits from pharmacies

The DVOT Antigen Combo Test Kit (6-in-1) lacks FDA Emergency Use Authorization or formal approval for clinical use, retail sale or self-testing in the United States and its territories. (yohohongkong.com)

By THE STAR STAFF

The Puerto Rico Clinical Laboratories Association (ALCPR by its initials in Spanish) and the Puerto Rico Society of Medical Technologists (CTMPR) are urging the island Department of Health and its Office of Regulation and Accreditation of Health Facilities to immediately remove influenza and other respiratory disease test kits being sold in local pharmacies without approval from the U.S. Food and Drug Administration (FDA).

Both organizations emphasized that clinical laboratories remain open and ready to serve patients.

The warning comes as Puerto Rico experiences one of the highest levels of influenza activity among U.S. jurisdictions, according to the Centers for Disease Control and Prevention (CDC). The island has surpassed both alert and epidemic thresholds, with more than 100 flu-related deaths reported this season, including pediatric fatalities.

“Timely and reliable influenza diagnosis is a critical public health intervention that saves lives,” ALCPR President Felipe Cintrón said. “Unauthorized tests put patients at risk by delivering potentially inaccurate results that delay proper treatment. Clinical laboratories are prepared to support efforts to curb the spread of influenza.”

CTMPR President Lina García added that “[m]edical technologists, as specialists in laboratory testing, urge the public to get tested for influenza and other respiratory illnesses in certified clinical laboratories.”

“We report positive results to the Department of Health, ensuring the accuracy of official data,” she said. “Using tests not approved by the FDA leads to errors, delays diagnoses, and increases the risk of virus transmission during a period of high community spread.”

The organizations specifically flagged the DVOT Antigen Combo Test Kit (6-in-1), which lacks FDA Emergency Use Authorization (EUA) or formal approval for clinical use, retail sale or self-testing in the United States and its territories.

The DVOT Antigen Combo Test (also known as the DVOT Multiplex Respiratory Antigen Combo Rapid Test) is manufactured by Feng Chun Yuan Medical Equipment Shenzhen Co. Ltd in China. The manufacturer did not answer requests for comment made via email.

FDA records show the manufacturer warned distributors in June 2024 that its rapid test kits “have not obtained the necessary FDA authorization (EUA & 510K)” and that selling these products in the U.S. “constitutes a direct violation of legal regulations and carries significant legal liabilities.” Despite the warnings, the product remains available in Puerto Rico pharmacies.

Recent data from Puerto Rico’s Department of Health show influenza activity continues to climb, with most recent cases linked to influenza A, which is often associated with more severe outcomes. Nationally, the CDC estimates that as of mid-December, the flu season has caused at least 4.6 million illnesses, 49,000 hospitalizations and 1,900 deaths.