Research

Direct-to-consumer self-tests sold in the UK in 2023: cross sectional review of information on intended use, instructions for use, and post-test decision making

Clare Davenport, Alex Richter, Bethany Hillier, et al

BMJ 2025; 390 doi: https://doi.org/10.1136/bmj-2025-085546 (Published 23 July 2025)Cite this as: BMJ 2025;390:e085546

Abstract

Objectives To review the information provided for self-test devices sold in high street shops in the UK and to assess their suitability for informed decision making based on use, interpretation, and post-test actions.

Design Cross sectional review of information on self-test boxes and instructions for use leaflets.

Setting Supermarkets, pharmacies, and health and wellbeing shops within a 10 mile radius of the University of Birmingham’s campus at Edgbaston in 2023.

Main outcome measures Information on intended use of test, biomarker and clinical condition, interpretation of test results, recommendations for post-test actions, and coherence of intended use and post-test recommendations with evidence based guidance.

Results 30 self-tests assessing 20 biomarkers for 19 different conditions were included. Information to guide purchase was present on a few boxes: who should use the test and when (8/30, 27%), action after the test result (7/30, 23%), and numerical test performance (10/30, 33%). From the information provided either on the box or within the instructions for use leaflets, 21 (70%) self-tests were judged to be used for diagnosis and 15 (50%) to be used for screening, although 3/21 (14%) did not provide any information about symptoms and 10/15 (67%) did not provide any information about risk factors to guide use. 27 (90%) self-tests recommended follow-up with a healthcare professional if results were positive or abnormal, and 14 (47%) if test results were negative or normal. Use of tests for 11 of 19 (58%) conditions was judged contrary to evidence based guidance in one or more of the intended population, frequency of testing, test threshold, or investigative approach required for a condition.

Table 1 

Test characteristics: Biomarkers, sample types, and indications for use

Test ID label	Product name (original cost)	Sample type		Biomarker	IFU clinical claim	Indication	Associated conditions	Symptoms for diagnosis	Characteristics to screen
T1	Menopause Test (£14.49)	Urine		FSH	Menopausal transition phase	Not stated	0	10	0
T2	Flourish Menopause Test Kit (£10.00)	Urine		FSH	Under menopausal process	Not stated	0	11	0
T3	Menopause (FSH) Rapid Test (£4.00)	Urine		FSH	Onset of menopause	Diagnosis	5	9	0
T4	FSH Rapid Menopause Test Midstream (£10.00)	Urine		FSH	Onset of menopause	Diagnosis	5	9	0
T5	SP-10 Male Fertility Rapid Test (£12.50)	Semen		Acrosomal protein SP-10	Low sperm concentration	Diagnosis, screening	0	1	0
T6	SpermCheck Fertility (£29.99)	Semen		Acrosomal protein SP-10	Low sperm concentration/count	Screening	0	0	0
T7	SwimCount Sperm Quality Test (£39.99)	Semen		Progressive motile sperm cells (cells/mL)	Predictor of male fertility	Not stated	0	0	0
T8	SURE CHECK HIV Self-Test (£33.95)	Capillary blood		Antibodies to HIV-1 and HIV-2	HIV infection	Screening	1	0	1
T9	Female Chlamydia STI Test Kit (£19.99)	Vaginal swab		Not stated	Chlamydia trachomatis	Not stated	9	0	0
T10	Women’s Intimate Self-test (£8.99)	Vaginal swab		Vaginal pH	Thrush, bacterial, or trichomoniasis infection	Diagnosis	0	7	0
T11	Canestest Self-test for Vaginal Infections (£7.50)	Vaginal swab		Vaginal pH	Bacterial vaginosis, thrush, trichomonas	Diagnosis	2	1	0
T12	Urine Infection Test (£14.49)	Urine		Protein, nitrite, and leucocytes		Diagnosis	0	6	0
T13	Bowel Health Test (£14.49)	Faeces		Human haemoglobin	Early stages of colon cancer	Not stated	5	0	2
T14	FOB Rapid Test (Faeces) (£10.00)	Faeces		Human haemoglobin		Not stated	6	0	0
T15	Prostate Health Test (£14.49)	Capillary blood		Prostate specific antigen	Indicator of prostate health	Not stated	4	0	2
T16	Stomach Ulcer Test (£14.49)	Capillary blood		Helicobacter pylori antibodies		Not stated	3	2	0
T17	Gluten Sensitivity Test (£17.49)	Capillary blood		Anti-tissue transglutaminase IgA antibodies		Not stated	2	9	0
T18	One step Strep A Swab test (£14.49)	Throat swab (tonsils)		Group A streptococcal antigen	Group A streptococcal infection	Diagnosis	6	2	0
T19	Flowflex Influenza A/B Rapid Test (Self-Testing) (£2.50)	Nasal swab		Influenza A antigen and influenza B antigen	Acute influenza type A and B viral infections	Diagnosis, screening	2	9	0
T20	Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (£1.93)	Nasal swab		SARS-CoV-2 nucleocapsid antigen	Covid-19	Diagnosis, screening	0	8	1
T21	One step test for SARS-CoV-2 Antigen (Colloidal Gold) (£2.00)	Nasal swab		SARS-CoV-2 nucleocapsid antigen	SARS-CoV-2 infection	Diagnosis, screening	0	7	1
T22	STEPAHEAD COVID-19 Antigen Rapid Test Kit (Swab) For Self-Testing (£1.89)	Nasal swab		SARS-CoV-2 nucleocapsid antigen	SARS-CoV-2 infection	Not stated	0	1	1
T23	Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold) (£8.00)	Urine		Albuminuria	Diagnosis of chronic kidney injury (CKI)	Diagnosis	4	0	0
T24	TSH Rapid Test Cassette (£10.00)	Capillary blood		TSH	Hypothyroidism	Diagnosis, screening	0	8	0
T25	Ferritin Rapid Test Cassette (£8.00)	Capillary blood		Ferritin	Iron deficiency anaemia	Not stated	8	12	0
T26	Iron Deficiency (£8.00)	Capillary blood		Ferritin	Iron deficiency anaemia	Not stated	4	5	0
T27	Vitamin D Rapid Test Cassette (£8.00)	Capillary blood		25-hydroxyvitamin D	Vitamin D deficiency	Diagnosis, screening, monitoring	18	0	0
T28	Vitamin D Test (£8.00)	Capillary blood		25-hydroxyvitamin D	Vitamin D deficiency	Diagnosis, screening, monitoring	18	0	0
T29	Cholesterol Level Test (£14.99)	Capillary blood		Total cholesterol	Hypercholesterolemia	Not stated	7	0	0
T30	Blood Glucose Test (£12.99)	Capillary blood		Blood glucose	Blood sugar level	Not stated	8	0	0

£1.00 (€1.16; $1.36).

FOB=faecal occult blood; FSH=follicle stimulating hormone; IFU=instructions for use; IgA=immunoglobulin A; STI=sexually transmitted infection; TSH=thyroid stimulating hormone.

Table 2 

Information provided at point of sale on self-test boxes

Test ID label	Health condition to be detected	Information about indications for testing	Biomarker stated	Advice after test	Claim about performance	Time to test result
T1	Menopause			Consult doctor	Reliable	3 minutes
T2	Menopause				Reliable	10 minutes
T3	Menopause		FSH		99% accurate	3 minutes
T4	Menopause		FSH		99% accurate	3 minutes
T5	Male fertility	Men	Sperm count		98% accurate	5 minutes
T6	Male fertility	Men. Trying to conceive	Sperm count	Test every 2/3 months	Proven accurate	Minutes*
T7	Sperm quality		Progressive motile sperm cells (PMSC)	Consult doctor or make lifestyle changes		30 minutes
T8	HIV viral infection	Not for those on antiretroviral treatment or in HIV vaccine trial	HIV infection	Confirming results with doctor		15 minutes
T9	Chlamydia in women	Women. Do not test during menstruation, pregnancy, or recent course antibiotics	Chlamydia infection			Minutes*
T10	Common vaginal infections	Women. One or more of itching, burning, pain when urinating, discharge, odour	Vaginal pH	Consult doctor or pharmacist	90% accurate	10 seconds
T11	Common vaginal infections	One or more of itching, burning, pain when urinating, discharge, odour	Vaginal pH	Seek attention for treatment	90% accurate	Seconds*
T12	Urine infections	One or more of burning when urinating, frequency, cloudy urine, odour, pain, fever	Protein, nitrite, leucocytes
T13	Symptoms of colon polyps (polyps precede bowel cancer)
T14	Bowel health (aid in the diagnosis of bowel cancer)		Occult blood		90% accurate	5 minutes
T15	Prostate health (enlargement of the prostate, prostatitis, urinary infection, early indication of prostate cancer)		PSA	Consult GP		10 minutes
T16	Stomach ulcer test		H pylori			10 minutes
T17	Gluten sensitivity test	Symptoms	TTG		97% accurate	15 minutes
T18	Streptococcus A detection		Strep A
T19	Influenza A/B		Influenza A/B
T20	SARS-CoV-2		SARS-CoV-2
T21	SARS-CoV-2		SARS-CoV-2
T22	Covid-19		Covid-19
T23	None		Albumin		98% accurate	3 minutes
T24	Underactive thyroid		TSH		98% accurate	3 minutes
T25	Iron deficiency		Ferritin		95% accurate	5 minutes
T26	Iron deficiency		Ferritin			5 minutes
T27	Vitamin D deficiency		Vit D		Clinically tested accuracy	10 minutes
T28	Vitamin D deficiency		25-hydroxy Vit D			10 minutes
T29	Cholesterol level		Cholesterol level			3 minutes
T30	Glucose		Glucose			Minutes*

FSH=follicle stimulating hormone; PSA=prostate specific antigen; Strep=streptococcus; TSH=thyroid stimulating hormone; TTG=tissue transglutaminase.

• * No specific duration specified.

Table 3 

Test interpretation and recommended actions

Test ID label: product name; result	Interpretation	Recommended medical contact	Treatment/actions	Further tests
T1: Menopause Test
Positive	Assume that you have reached post menopause if both test results are positive			Repeat the test a week later if first is positive
Negative	You have not yet reached post-menopause
T2: Flourish Menopause Test Kit
Positive	You could be under menopausal process if both test results are positive	Gynaecologist		Repeat the test 5-7 days later if first is positive
Negative	You are probably not under menopausal process	Gynaecologist		Repeat test 40-60 days later if you still have symptoms
T3: Menopause (FSH) Rapid Test
Perimenopausal symptoms:
Positive	Most likely (two positive test results) or may be in perimenopause (one positive test)	Doctor	Do not immediately discontinue contraception
Negative	Most likely not experiencing perimenopause	Doctor		Test can be repeated
Menopausal symptoms:
Positive	Menopause has most likely occurred (after one positive test)
Negative				Repeat testing in following month if still have symptoms
T4: FSH Rapid Menopause Test Midstream
Perimenopausal symptoms:
Positive	Most likely (two positive test results) or may be in perimenopause (one positive test)	Doctor	Do not immediately discontinue contraception
Negative	Most likely not experiencing perimenopause	Doctor		Test can be repeated
Menopausal symptoms:
Positive	Menopause has most likely occurred (one positive test)
Negative				Repeat testing in following month if still have symptoms
T5: SP-10 Male Fertility Rapid Test
Positive	Sperm concentration is less than 15 million/mL	Expert medical advice
Negative	Sperm concentration is above 15 million/mL
T6: SpermCheck Fertility
Positive	Sperm count concentration is less than 15 million/mL	Doctor	Possible treatment for subfertility as advised by doctor	Complete semen analysis
Negative	Sperm count is at least 15 million/mL	Doctor if still experiencing fertility issues		Complete semen analysis and fertility evaluation for partner
T7: SwimCount Sperm Quality Test
Positive	PMSC concentration is lower than for fertile men; may be unable to get your partner pregnant naturally	Doctor	Lifestyle changes to improve sperm concentration	Repeat test in three months after lifestyle changes
Negative	PMSC concentration is normal; high chance making partner pregnant naturally	Doctor if still experiencing fertility issues
T8: SURE CHECK HIV Self-Test
Positive	Probably HIV positive	Doctor	Protect yourself and others	Confirmatory laboratory test
Negative	Probably HIV negative	Doctor if possibility of being in the seroconversion period		Repeat the test in 3 months if possible exposure to HIV
T9: Female Chlamydia STI Test Kit
Positive		Doctor	Sexual partner should also take a test and undergo treatment
Negative	Highly unlikely to have chlamydia			Regular testing recommended
T10: Women’s Intimate Self-test
Positive	Vaginal pH is higher than normal; probably have bacterial vaginosis/trichomoniasis dependent on symptoms	Pharmacist if bacterial vaginosis suspected; doctor if trichomoniasis suspected	Product for bacterial vaginosis from pharmacist; treatment for trichomoniasis from doctor
Negative	Vaginal pH is normal; probably have thrush if symptoms are present	Pharmacist if thrush is suspected	Products for thrush advised by pharmacist
T11: Canestest Self-test for Vaginal Infections
Positive	Vaginal pH is higher than normal; probably have bacterial vaginosis/trichomoniasis infection dependent on symptoms	Pharmacist if bacterial vaginosis suspected; doctor if trichomoniasis suspected or if no symptoms	Treatment for bacterial vaginosis from pharmacist or doctor; trichomoniasis from doctor
Negative	Vaginal pH is normal; probably have thrush if symptoms are present	Pharmacist if thrush suspected	Over-the-counter thrush products
T12: Urine Infection Test
Positive	Likely that something is wrong with your urine	GP		Further investigation by GP
Negative		Doctor if symptoms persist
T13: Bowel Health Test
Positive	Blood detected in stool	Doctor
Negative	No blood detected in stool (does not exclude possibility of bowel condition)			Test yourself or arrange to be tested annually from age 40 years
T14: FOB Rapid Test (Faeces)
Positive	Blood in faeces does not necessarily indicate colorectal bleeding	Doctor
Negative
T15: Prostate Health Test
Positive	PSA level is higher than normal (4 ng/mL)	Doctor
Negative	PSA level is in the normal range			Regular testing if between 50 and 75 years of family history
T16: Stomach Ulcer Test
Positive	H. pylori antibodies detected	Doctor
Negative	No H. pylori antibodies detected	Doctor if symptoms persist
T17: Gluten Sensitivity Test
Positive	Anti-t-TG IgA type antibodies are present	Doctor
Negative	No anti-t-TG IgA type antibodies detected	Doctor if symptoms persist
T18: One step Strep A Swab test
Positive	May be in a stage of Strep A infection	Doctor
Negative	Concentration of Strep A antigen is zero or below detection limit (probably not infected)	Doctor if symptoms persist or experience serious complications
T19: Flowflex Influenza A/B Rapid Test (Self-Testing)
Positive	Influenza A or B antigen detected			Alternative confirmatory tests
Negative	No influenza or A/B antigen detected (does not preclude influenza or other infections)			Alternative confirmatory tests
T20: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)
Positive	Presence of SARS-CoV-2 antigen; very likely infected with covid-19	Doctor	Follow self-isolation rules; contact local health department	PCR test
Negative	Unlikely to currently have covid-19; infection may still be present (does not rule out other infections)		Follow current rules	Repeat test after 1-2 days if infection suspected; molecular assay if necessary
T21: One step test for SARS-CoV-2 Antigen (Colloidal Gold)
Positive	Presence of SARS-CoV-2 antigen; likely to have covid-19	Doctor	Follow self-isolation rules; contact local health department	Molecular testing
Negative	No SARS-CoV-2 antigen detected; unlikely to be infected with covid-19; there may still be an infection		Follow current rules	Repeat test after 1-2 days if infection suspected or with a molecular assay
T22: STEPAHEAD COVID-19 Antigen Rapid Test Kit (Swab) For Self-Testing
Positive	Presence of SARS-CoV-2; suspicion of covid-19 infection	Doctor	Follow self-isolation rules; contact local health department	PCR test
Negative	Does not preclude SARS-CoV-2 infection; there may still be an infection	Healthcare provider if still experiencing covid-like symptoms	Follow current rules	Repeat test after 1-2 days if infection suspected
T23: Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold)
Positive	Albumin in urine is more than 20 mg/L (does not necessarily indicate kidney injury)
Negative	Albumin in urine is less than the cutoff value
T24: TSH Rapid Test Cassette
Positive	TSH level is higher than normal (5 μIU/mL) (indicates an underactive thyroid (hypothyroidism))	Physician; repeatedly abnormal results discussed with doctor		Further tests decided by physician; quantitative laboratory TSH assay
Negative	TSH below 5 μIU/mL within normal range (not in range to consider hypothyroidism; hyperthyroidism cannot be excluded)	Physician if symptoms persist		Quantitative laboratory TSH assay
T25: Ferritin Rapid Test Cassette
Positive	Ferritin concentration in blood is lower than 30 ng/mL; possible iron deficiency	Physician; repeatedly abnormal results discussed with doctor		Tests decided by physician; use a secondary analytical method
Negative	Ferritin higher than 30 ng/mL and within normal range; no potential iron deficiency	Physician if symptoms persist		Use a secondary analytical method
T26: Iron Deficiency
Positive	Ferritin concentration in blood is lower than 30 ng/mL; possible iron deficiency	Physician; repeatedly abnormal results discussed with doctor		Tests decided by physician; use a secondary analytical method
Negative	Ferritin higher than 30 ng/mL and within normal range; no potential iron deficiency	Physician if symptoms persist		Use a secondary analytical method
T27: Vitamin D Rapid Test Cassette
Positive	Vitamin D level is less than 30 ng/mL (deficient or insufficient)	Physician if result is deficient, insufficient, or excess	Vitamin D supplements	Tests decided by physician; use a secondary analytical method
Negative	Vitamin D level is higher than or equal to 30 ng/mL and within normal range	Physician if symptoms persist		Use a secondary analytical method
T28: Vitamin D Test
Positive	Vitamin D level is less than 30 ng/mL (deficient or insufficient)	Physician if result is deficient, insufficient, or excess	Vitamin D supplements	Tests decided by physician; use a secondary analytical method
Negative	Vitamin D level is higher than or equal to 30 ng/mL and within normal range	Physician if symptoms persist		Secondary analytical method
T29: Cholesterol Level Test
Positive	Cholesterol level is probably high if above 5.2 mmol/L	Doctor	Treatment as advised by doctor	Further tests as decided by doctor
Negative	Cholesterol is probably normal if level is less than 5.2 mmol/L
T30: Blood Glucose Test
Positive	Below 3.9 or above 6.1 mmol/L blood sugar level is outside the normal range	Doctor if both tests are abnormal		Repeat test on a different day; detailed assessment by doctor

Anti-t-TG=anti-tissue transglutaminase FOB=faecal occult blood; PMSC=progressive motile sperm cells; PCR=polymerase chain reaction; PSA=prostate specific antigen; STI=sexually transmitted infection; TSH=thyroid stimulating hormone.

Conclusions The current market for self-tests does not support consumer informed decisions about their use, interpretation of test results, and subsequent actions. Clinicians working downstream of self-tests are likely to face important challenges in incorporating the results in practice. As the use of self-tests continues to increase, improved regulatory oversight is urgently needed to protect the public and healthcare systems from misuse.