The COVID-19 pandemic made rapid tests a household tool. Now, similar kits promise to detect everything from urinary tract infections (UTIs) to vitamin D deficiency or the onset of menopause.

Doctors, however, remain wary. The sensitivity of over-the-counter (OTC) tests is lower than hospital lab analyses — and user error can skew results even more.

Markus Kariis, a urological surgery resident at North Estonia Medical Center (PERH), said urine strip tests — where paper test strips change color after coming in contact with urine — offer little diagnostic value.

"They aren't really that useful," he said, noting that at-home testing doesn't do much for someone who suspects they have a bladder infection, for example.

False positives and false negatives are common, often due to incorrect use. A false positive might suggest an infection that isn't there, while a false negative can hide one that is.

To get a more accurate result, Kariis said urine should be collected in a sterile container using the "midstream" method — in which the patient urinates a small amount into the toilet before collecting the sample and finishes urinating in the toilet afterward. Patients should also wash their genitals before collecting a sample, regardless of gender.

Other factors also matter. Menstrual blood ending up in a urine sample can automatically turn a test positive, and improper storage — such as an unsealed package — can affect a test kit's accuracy as well.

"As a rule of thumb, all OTC tests, which we call point-of-care tests (POCT), have poorer sensitivity and specificity than hospital tests," the resident said.

Hospital labs can measure around ten parameters, including nitrates, blood and leukocytes. If needed, providers can also grow bacteria from samples to identify the exact infection.

Skip testing and get seen

Kariis said anyone experiencing pain during urination, cloudy urine or frequent urges to urinate should skip the at-home tests altogether and be seen by a doctor.

Jaanus Kahu, a urologist and lecturer at Tartu University Hospital (TÜK), agreed, noting that he as a hospital physician doesn't use them.

Urine tests are "developing rapidly and have their place" as screening tools, he acknowledged, but they're "still somewhat questionable" for confirming illness.

Tests claiming to detect menopause may be somewhat better, Kariis said, but still aren't sufficient grounds for diagnosis. The test may alert its user to the possibility that menopause has begun. "But I think that should definitely be confirmed by a doctor," he added.

Even if doctors doubt their usefulness, the sale of such rapid tests is regulated in the EU, including in Estonia.

Piret Põiklik, head of the Medical Devices Department at Estonia's State Agency of Medicines (RA), said manufacturers are responsible for making sure their products work as advertised.

"As a general rule, the manufacturer is responsible for ensuring that the test they sell functions exactly as they claim to the buyer," Põiklik said.

Stick to reputable sellers

Before a manufacturer can sell its tests, it must first be certified by a notified body — an EU-approved organization that confirms products meet requirements before being put on the market.

In Estonia, distributors such as pharmacies are responsible for ensuring that tests on the market are properly labeled and include product information leaflets in Estonian.

While a manufacturer's location, such as in China, isn't automatically a red flag, Põiklik urged consumers to stick to buying test kits from reputable local sellers. Ordering from online stores, especially from outside the EU, risks getting a product that doesn't meet EU standards.

Doctors' advice, in any case, remains clear. "I wouldn't recommend anyone use point-of-care tests other than COVID tests," Kariis said, confirming that COVID-19 tests are sufficiently sensitive. "It's better to be seen at a hospital or by your doctor."

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