Strep throat is one of the most common medical conditions encountered in the community. But the chief symptom of Strep (sore throat), can also be caused by other things like viruses, allergies and smoking/vaping. In order to distinguish between Strep and these other causes, testing is always necessary.
Unfortunately, Strep Testing must be performed by trained medical professionals in a hospital setting. Even CLIA waived test kits cannot be purchased by a layperson. Luckily, one company is now seeking FDA approval for their device which will allow anybody to perform at home strep testing in the comfort of their own home.
Checkable Medical; At Home Strep Test Kit
Checkable Medical, a Fargo, North Dakota based company has developed a home-based rapid Strep Test kit as a solution for those who are suffering from a sore throat and wanting to test for Strep at home.
The kit includes material for collecting a throat swab along with directions for obtaining a proper specimen. Once the swab is collected, it is mixed with a chemical that reacts with Streptococcus pyogenes bacteria if present, giving either a positive or negative result in 10 minutes.
If you test positive for Strep, will you be able to get medications prescribed?
Yes, if a positive result is attained, Checkable has a phone app which can be logged into in order to get antibiotics like Penicillin or Amoxicillin prescribed by one of their primary care physicians on staff.
Are there any other home Strep Test kits available?
Currently, no. But if approved for use, Checkable will be the first and only home-based Strep Test kit available on the market. As of now, there are several CLIA-Waived Strep kits already available, however they are not approved for home use, only hospital use. The only way to purchase one of those kits is to be a healthcare business with a CLIA certificate, essentially limiting access for millions of Americans.
Is the Checkable Strep Test kit available yet?
Not yet. The company has completed a clinical study already, however, their FDA clearance application for over-the-counter home use is still pending. But once FDA approval is attained, the kits will be available for sale in pharmacies like CVS and Walgreens, as well as select online retailers.
What are some benefits of home Strep Testing?
Time/Convenience
Traditional Strep Testing requires transportation time to & from a doctor office, meeting with the doctor, waiting on results to come back from the lab, then waiting at the pharmacy to pick up medication, taking hours out of the day. Whereas with this home test, the only major time sacrifice is driving to the pharmacy to pick up the medication if the test is positive.
Money
Doctor visits usually involve some sort of co-pay as well as gas money to get there. Also, time may have to be taken off of work. These costs are very likely to be more expensive than the cost of a home test kit.
Are there any drawbacks to home Strep Testing?
Lack of Bacterial Culture
Traditional Strep testing typically requires getting 2 swabs from the patient. The first swab is used for the rapid test and the second swab is used to inoculate agar plates for a culture. The culture is used as confirmation of Strep pyogenes, since rapid tests do have a certain percentage of false-positive results. The culture can also be used to confirm a negative rapid test result, since there can be false negatives as well. In the event of a negative rapid result, the culture can still ensure that the organism is identified, so that the patient can still get the appropriate medication, if present, for treatment. With home-based Strep Testing, there is no second swab obtained for culture, so the rapid result is the sole basis used for identification, no confirmation of a false-positive or false-negative is possible. Additionally, if growth is seen on the agar, further testing with latex agglutination is done to confirm that the isolated organism is Strep A (Strep pyogenes) and not another species like Strep B, C, D, G or Viridans. Culturing requires agar media, Lancefield agglutination kits, inoculation loops, incubators, CO2 tanks and a trained lab technician. This keeps culturing as a definite non-option for the layperson.
Risk for Procedural Deviation
Despite the CLIA-Waived tests being easy to perform and straight-forward, there is still room for variance. This is to be expected, given the fact that unlike a medical professional, the average layperson lacks any sort of training in specimen recovery and testing. This can mean a higher likelihood that the swab could be improperly collected or a step in the procedure could inadvertently be performed incorrectly, or forgotten altogether. One wrong step can mean an invalid result. The consequences of a false-negative result could mean missing out on the proper treatment and possibly further spread to other people. It could even mean progression into more severe conditions like Scarlet Fever or Rheumatic Fever. Given the test’s waived status, the risk is low, nevertheless still present.
Conclusion
Strep throat is a common condition which affects many Americans every year. However, if approved, Checkable’s home-based test kit will make taking a trip to the doctor for Strep testing a thing of the past.
References
Home Strep Tests? Yes, It’s a Thing. (2022, February 10). Retrieved from Checkable: https://www.checkable.com/blogs/blog/home-strep-tests-yes-its-a-thing
