FDA approves first-ever at-home test for gonorrhoea, chlamydia


LetsGetChecked, a New York-based lab testing company, will market the Simple 2 Test

FDA approves first-ever at-home test for chlamydia, gonorrhoea amid soaring STDs.—AFP/file
FDA approves first-ever at-home test for chlamydia, gonorrhoea amid soaring STDs.—AFP/file 

The Food and Drug Administration has approved the first-ever at-home diagnostic tests for chlamydia and gonorrhoea in response to the escalating STD epidemic in the United States.

LetsGetChecked, a New York-based lab testing company, will market the Simple 2 Test, aiming to provide a convenient and private solution for individuals concerned about their sexual health.

Rather than requiring individuals to visit a healthcare facility, this innovative test kit is initiated through a comprehensive health questionnaire filled out by the patient, which is then reviewed by a qualified doctor. 

The Simple 2 Test is subsequently mailed directly to the patient for at-home use, with the collected samples returned by mail to a certified laboratory for analysis.

LetsGetChecked specialises in empowering individuals to take samples in the comfort of their homes, send them to a lab, and securely deliver results online. Priced at $99, the Simple 2 Test does not necessitate a prescription, eliminating the need for a visit to a doctor’s office for invasive testing.

Federal regulators view this development as a crucial win for public health, offering a means to address the persistent rise in STD rates in the US, a trend exacerbated during the pandemic due to restricted access to regular preventative care.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasised the significance of this authorisation in advancing consumer access to diagnostic tests, aligning with the broader goal of bringing more healthcare services into the home.

The Simple 2 Test, following in the footsteps of at-home HIV screening, represents the first FDA-approved self-test for chlamydia and gonorrhoea. Patients receive the discreetly packaged test at their doorstep, complete a health questionnaire for doctor review, and submit vaginal swabs or urine samples. 

The collected samples are sent via mail to accredited labs, ensuring result accuracy, and individuals receive results within two to five days through a secure online portal.

While the at-home test presents the risk of false negatives, the FDA warns that this could lead to delays in effective treatment and increased community spread. However, LetsGetChecked offers consultation services and, if needed, assists in administering required medications.

In addition to benefiting individuals who test positive, LetsGetChecked extends its services to partners, providing treatment options at an additional cost. This approach aims to address the interconnected nature of sexual health and minimise the spread of STDs within communities.

The surge in STD cases, totalling 2.53 million in 2021, underscores the urgent need for accessible and discreet testing options. LetsGetChecked’s Simple 2 Test addresses the challenges posed by the pandemic, promoting sexual health awareness and empowering individuals to seek timely treatment. 

The rise in cases is attributed to factors such as low access to preventative care, decreased disease screening during the pandemic, and evolving attitudes toward contraception, emphasising the need for proactive measures to curb the spread of STDs.



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