{"id":28861,"date":"2025-09-17T04:36:00","date_gmt":"2025-09-16T20:36:00","guid":{"rendered":"https:\/\/csccm.org.cn\/?p=28861"},"modified":"2025-09-17T05:40:30","modified_gmt":"2025-09-16T21:40:30","slug":"bmj%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a2023%e5%b9%b4%e8%8b%b1%e5%9b%bd%e7%9b%b4%e6%8e%a5%e9%9d%a2%e5%90%91%e6%b6%88%e8%b4%b9%e8%80%85%e9%94%80%e5%94%ae%e7%9a%84%e8%87%aa%e6%88%91%e6%a3%80","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=28861","title":{"rendered":"[BMJ\u53d1\u8868\u8bba\u6587]\uff1a2023\u5e74\u82f1\u56fd\u76f4\u63a5\u9762\u5411\u6d88\u8d39\u8005\u9500\u552e\u7684\u81ea\u6211\u68c0\u6d4b\uff1a\u7528\u9014\u3001\u4f7f\u7528\u8bf4\u660e\u53ca\u68c0\u9a8c\u540e\u51b3\u7b56"},"content":{"rendered":"\n<p><strong>Research<\/strong><\/p>\n\n\n\n<h1 class=\"wp-block-heading\" id=\"page-title\">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<\/h1>\n\n\n\n<h3 class=\"wp-block-heading\">Clare Davenport, Alex Richter, Bethany Hillier,\u00a0et al<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><em>BMJ<\/em>\u00a02025;\u00a0390\u00a0doi:\u00a0<a href=\"https:\/\/doi.org\/10.1136\/bmj-2025-085546\">https:\/\/doi.org\/10.1136\/bmj-2025-085546<\/a>\u00a0(Published 23 July 2025)Cite this as:\u00a0<em>BMJ<\/em>\u00a02025;390:e085546<\/h3>\n\n\n\n<h2 class=\"wp-block-heading\">Abstract<\/h2>\n\n\n\n<p id=\"p-2\"><strong>Objectives<\/strong>&nbsp;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.<\/p>\n\n\n\n<p id=\"p-3\"><strong>Design<\/strong>&nbsp;Cross sectional review of information on self-test boxes and instructions for use leaflets.<\/p>\n\n\n\n<p id=\"p-4\"><strong>Setting<\/strong>&nbsp;Supermarkets, pharmacies, and health and wellbeing shops within a 10 mile radius of the University of Birmingham\u2019s campus at Edgbaston in 2023.<\/p>\n\n\n\n<p id=\"p-5\"><strong>Main outcome measures<\/strong>&nbsp;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.<\/p>\n\n\n\n<p id=\"p-6\"><strong>Results<\/strong>\u00a030 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.<\/p>\n\n\n\n<p><strong>Table 1<\/strong>&nbsp;<\/p>\n\n\n\n<p id=\"p-20\">Test characteristics: Biomarkers, sample types, and indications for use<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>Test ID label<\/th><th>Product name (original cost)<\/th><th>Sample type<\/th><th><\/th><th>Biomarker<\/th><th>IFU clinical claim<\/th><th>Indication<\/th><th>Associated conditions<\/th><th>Symptoms for diagnosis<\/th><th>Characteristics to screen<\/th><\/tr><\/thead><tbody><tr><td>T1<\/td><td>Menopause Test (\u00a314.49)<\/td><td>Urine<\/td><td><\/td><td>FSH<\/td><td>Menopausal transition phase<\/td><td>Not stated<\/td><td>0<\/td><td>10<\/td><td>0<\/td><\/tr><tr><td>T2<\/td><td>Flourish Menopause Test Kit (\u00a310.00)<\/td><td>Urine<\/td><td><\/td><td>FSH<\/td><td>Under menopausal process<\/td><td>Not stated<\/td><td>0<\/td><td>11<\/td><td>0<\/td><\/tr><tr><td>T3<\/td><td>Menopause (FSH) Rapid Test (\u00a34.00)<\/td><td>Urine<\/td><td><\/td><td>FSH<\/td><td>Onset of menopause<\/td><td>Diagnosis<\/td><td>5<\/td><td>9<\/td><td>0<\/td><\/tr><tr><td>T4<\/td><td>FSH Rapid Menopause Test Midstream (\u00a310.00)<\/td><td>Urine<\/td><td><\/td><td>FSH<\/td><td>Onset of menopause<\/td><td>Diagnosis<\/td><td>5<\/td><td>9<\/td><td>0<\/td><\/tr><tr><td>T5<\/td><td>SP-10 Male Fertility Rapid Test (\u00a312.50)<\/td><td>Semen<\/td><td><\/td><td>Acrosomal protein SP-10<\/td><td>Low sperm concentration<\/td><td>Diagnosis, screening<\/td><td>0<\/td><td>1<\/td><td>0<\/td><\/tr><tr><td>T6<\/td><td>SpermCheck Fertility (\u00a329.99)<\/td><td>Semen<\/td><td><\/td><td>Acrosomal protein SP-10<\/td><td>Low sperm concentration\/count<\/td><td>Screening<\/td><td>0<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T7<\/td><td>SwimCount Sperm Quality Test (\u00a339.99)<\/td><td>Semen<\/td><td><\/td><td>Progressive motile sperm cells (cells\/mL)<\/td><td>Predictor of male fertility<\/td><td>Not stated<\/td><td>0<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T8<\/td><td>SURE CHECK HIV Self-Test (\u00a333.95)<\/td><td>Capillary blood<\/td><td><\/td><td>Antibodies to HIV-1 and HIV-2<\/td><td>HIV infection<\/td><td>Screening<\/td><td>1<\/td><td>0<\/td><td>1<\/td><\/tr><tr><td>T9<\/td><td>Female Chlamydia STI Test Kit (\u00a319.99)<\/td><td>Vaginal swab<\/td><td><\/td><td>Not stated<\/td><td><em>Chlamydia trachomatis<\/em><\/td><td>Not stated<\/td><td>9<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T10<\/td><td>Women\u2019s Intimate Self-test (\u00a38.99)<\/td><td>Vaginal swab<\/td><td><\/td><td>Vaginal pH<\/td><td>Thrush, bacterial, or trichomoniasis infection<\/td><td>Diagnosis<\/td><td>0<\/td><td>7<\/td><td>0<\/td><\/tr><tr><td>T11<\/td><td>Canestest Self-test for Vaginal Infections (\u00a37.50)<\/td><td>Vaginal swab<\/td><td><\/td><td>Vaginal pH<\/td><td>Bacterial vaginosis, thrush, trichomonas<\/td><td>Diagnosis<\/td><td>2<\/td><td>1<\/td><td>0<\/td><\/tr><tr><td>T12<\/td><td>Urine Infection Test (\u00a314.49)<\/td><td>Urine<\/td><td><\/td><td>Protein, nitrite, and leucocytes<\/td><td>&nbsp;<\/td><td>Diagnosis<\/td><td>0<\/td><td>6<\/td><td>0<\/td><\/tr><tr><td>T13<\/td><td>Bowel Health Test (\u00a314.49)<\/td><td>Faeces<\/td><td><\/td><td>Human haemoglobin<\/td><td>Early stages of colon cancer<\/td><td>Not stated<\/td><td>5<\/td><td>0<\/td><td>2<\/td><\/tr><tr><td>T14<\/td><td>FOB Rapid Test (Faeces) (\u00a310.00)<\/td><td>Faeces<\/td><td><\/td><td>Human haemoglobin<\/td><td>&nbsp;<\/td><td>Not stated<\/td><td>6<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T15<\/td><td>Prostate Health Test (\u00a314.49)<\/td><td>Capillary blood<\/td><td><\/td><td>Prostate specific antigen<\/td><td>Indicator of prostate health<\/td><td>Not stated<\/td><td>4<\/td><td>0<\/td><td>2<\/td><\/tr><tr><td>T16<\/td><td>Stomach Ulcer Test (\u00a314.49)<\/td><td>Capillary blood<\/td><td><\/td><td><em>Helicobacter pylori<\/em>&nbsp;antibodies<\/td><td>&nbsp;<\/td><td>Not stated<\/td><td>3<\/td><td>2<\/td><td>0<\/td><\/tr><tr><td>T17<\/td><td>Gluten Sensitivity Test (\u00a317.49)<\/td><td>Capillary blood<\/td><td><\/td><td>Anti-tissue transglutaminase IgA antibodies<\/td><td>&nbsp;<\/td><td>Not stated<\/td><td>2<\/td><td>9<\/td><td>0<\/td><\/tr><tr><td>T18<\/td><td>One step Strep A Swab test (\u00a314.49)<\/td><td>Throat swab (tonsils)<\/td><td><\/td><td>Group A streptococcal antigen<\/td><td>Group A streptococcal infection<\/td><td>Diagnosis<\/td><td>6<\/td><td>2<\/td><td>0<\/td><\/tr><tr><td>T19<\/td><td>Flowflex Influenza A\/B Rapid Test (Self-Testing) (\u00a32.50)<\/td><td>Nasal swab<\/td><td><\/td><td>Influenza A antigen and influenza B antigen<\/td><td>Acute influenza type A and B viral infections<\/td><td>Diagnosis, screening<\/td><td>2<\/td><td>9<\/td><td>0<\/td><\/tr><tr><td>T20<\/td><td>Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (\u00a31.93)<\/td><td>Nasal swab<\/td><td><\/td><td>SARS-CoV-2 nucleocapsid antigen<\/td><td>Covid-19<\/td><td>Diagnosis, screening<\/td><td>0<\/td><td>8<\/td><td>1<\/td><\/tr><tr><td>T21<\/td><td>One step test for SARS-CoV-2 Antigen (Colloidal Gold) (\u00a32.00)<\/td><td>Nasal swab<\/td><td><\/td><td>SARS-CoV-2 nucleocapsid antigen<\/td><td>SARS-CoV-2 infection<\/td><td>Diagnosis, screening<\/td><td>0<\/td><td>7<\/td><td>1<\/td><\/tr><tr><td>T22<\/td><td>STEPAHEAD COVID-19 Antigen Rapid Test Kit (Swab) For Self-Testing (\u00a31.89)<\/td><td>Nasal swab<\/td><td><\/td><td>SARS-CoV-2 nucleocapsid antigen<\/td><td>SARS-CoV-2 infection<\/td><td>Not stated<\/td><td>0<\/td><td>1<\/td><td>1<\/td><\/tr><tr><td>T23<\/td><td>Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold) (\u00a38.00)<\/td><td>Urine<\/td><td><\/td><td>Albuminuria<\/td><td>Diagnosis of chronic kidney injury (CKI)<\/td><td>Diagnosis<\/td><td>4<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T24<\/td><td>TSH Rapid Test Cassette (\u00a310.00)<\/td><td>Capillary blood<\/td><td><\/td><td>TSH<\/td><td>Hypothyroidism<\/td><td>Diagnosis, screening<\/td><td>0<\/td><td>8<\/td><td>0<\/td><\/tr><tr><td>T25<\/td><td>Ferritin Rapid Test Cassette (\u00a38.00)<\/td><td>Capillary blood<\/td><td><\/td><td>Ferritin<\/td><td>Iron deficiency anaemia<\/td><td>Not stated<\/td><td>8<\/td><td>12<\/td><td>0<\/td><\/tr><tr><td>T26<\/td><td>Iron Deficiency (\u00a38.00)<\/td><td>Capillary blood<\/td><td><\/td><td>Ferritin<\/td><td>Iron deficiency anaemia<\/td><td>Not stated<\/td><td>4<\/td><td>5<\/td><td>0<\/td><\/tr><tr><td>T27<\/td><td>Vitamin D Rapid Test Cassette (\u00a38.00)<\/td><td>Capillary blood<\/td><td><\/td><td>25-hydroxyvitamin D<\/td><td>Vitamin D deficiency<\/td><td>Diagnosis, screening, monitoring<\/td><td>18<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T28<\/td><td>Vitamin D Test (\u00a38.00)<\/td><td>Capillary blood<\/td><td><\/td><td>25-hydroxyvitamin D<\/td><td>Vitamin D deficiency<\/td><td>Diagnosis, screening, monitoring<\/td><td>18<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T29<\/td><td>Cholesterol Level Test (\u00a314.99)<\/td><td>Capillary blood<\/td><td><\/td><td>Total cholesterol<\/td><td>Hypercholesterolemia<\/td><td>Not stated<\/td><td>7<\/td><td>0<\/td><td>0<\/td><\/tr><tr><td>T30<\/td><td>Blood Glucose Test (\u00a312.99)<\/td><td>Capillary blood<\/td><td><\/td><td>Blood glucose<\/td><td>Blood sugar level<\/td><td>Not stated<\/td><td>8<\/td><td>0<\/td><td>0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p id=\"p-21\">\u00a31.00 (\u20ac1.16; $1.36).<\/p>\n\n\n\n<p id=\"p-22\">FOB=faecal occult blood; FSH=follicle stimulating hormone; IFU=instructions for use; IgA=immunoglobulin A; STI=sexually transmitted infection; TSH=thyroid stimulating hormone.<\/p>\n\n\n\n<p><strong>Table 2<\/strong>&nbsp;<\/p>\n\n\n\n<p id=\"p-26\">Information provided at point of sale on self-test boxes<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>Test ID label<\/th><th>Health condition to be detected<\/th><th>Information about indications for testing<\/th><th>Biomarker stated<\/th><th>Advice after test<\/th><th>Claim about performance<\/th><th>Time to test result<\/th><\/tr><\/thead><tbody><tr><td>T1<\/td><td>Menopause<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Consult doctor<\/td><td>Reliable<\/td><td>3 minutes<\/td><\/tr><tr><td>T2<\/td><td>Menopause<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Reliable<\/td><td>10 minutes<\/td><\/tr><tr><td>T3<\/td><td>Menopause<\/td><td>&nbsp;<\/td><td>FSH<\/td><td>&nbsp;<\/td><td>99% accurate<\/td><td>3 minutes<\/td><\/tr><tr><td>T4<\/td><td>Menopause<\/td><td>&nbsp;<\/td><td>FSH<\/td><td>&nbsp;<\/td><td>99% accurate<\/td><td>3 minutes<\/td><\/tr><tr><td>T5<\/td><td>Male fertility<\/td><td>Men<\/td><td>Sperm count<\/td><td>&nbsp;<\/td><td>98% accurate<\/td><td>5 minutes<\/td><\/tr><tr><td>T6<\/td><td>Male fertility<\/td><td>Men. Trying to conceive<\/td><td>Sperm count<\/td><td>Test every 2\/3 months<\/td><td>Proven accurate<\/td><td>Minutes*<\/td><\/tr><tr><td>T7<\/td><td>Sperm quality<\/td><td>&nbsp;<\/td><td>Progressive motile sperm cells (PMSC)<\/td><td>Consult doctor or make lifestyle changes<\/td><td>&nbsp;<\/td><td>30 minutes<\/td><\/tr><tr><td>T8<\/td><td>HIV viral infection<\/td><td>Not for those on antiretroviral treatment or in HIV vaccine trial<\/td><td>HIV infection<\/td><td>Confirming results with doctor<\/td><td>&nbsp;<\/td><td>15 minutes<\/td><\/tr><tr><td>T9<\/td><td>Chlamydia in women<\/td><td>Women. Do not test during menstruation, pregnancy, or recent course antibiotics<\/td><td>Chlamydia infection<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Minutes*<\/td><\/tr><tr><td>T10<\/td><td>Common vaginal infections<\/td><td>Women. One or more of itching, burning, pain when urinating, discharge, odour<\/td><td>Vaginal pH<\/td><td>Consult doctor or pharmacist<\/td><td>90% accurate<\/td><td>10 seconds<\/td><\/tr><tr><td>T11<\/td><td>Common vaginal infections<\/td><td>One or more of itching, burning, pain when urinating, discharge, odour<\/td><td>Vaginal pH<\/td><td>Seek attention for treatment<\/td><td>90% accurate<\/td><td>Seconds*<\/td><\/tr><tr><td>T12<\/td><td>Urine infections<\/td><td>One or more of burning when urinating, frequency, cloudy urine, odour, pain, fever<\/td><td>Protein, nitrite, leucocytes<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>T13<\/td><td>Symptoms of colon polyps (polyps precede bowel cancer)<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>T14<\/td><td>Bowel health (aid in the diagnosis of bowel cancer)<\/td><td>&nbsp;<\/td><td>Occult blood<\/td><td>&nbsp;<\/td><td>90% accurate<\/td><td>5 minutes<\/td><\/tr><tr><td>T15<\/td><td>Prostate health (enlargement of the prostate, prostatitis, urinary infection, early indication of prostate cancer)<\/td><td>&nbsp;<\/td><td>PSA<\/td><td>Consult GP<\/td><td>&nbsp;<\/td><td>10 minutes<\/td><\/tr><tr><td>T16<\/td><td>Stomach ulcer test<\/td><td>&nbsp;<\/td><td><em>H pylori<\/em><\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>10 minutes<\/td><\/tr><tr><td>T17<\/td><td>Gluten sensitivity test<\/td><td>Symptoms<\/td><td>TTG<\/td><td>&nbsp;<\/td><td>97% accurate<\/td><td>15 minutes<\/td><\/tr><tr><td>T18<\/td><td>Streptococcus A detection<\/td><td>&nbsp;<\/td><td>Strep A<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>T19<\/td><td>Influenza A\/B<\/td><td>&nbsp;<\/td><td>Influenza A\/B<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>T20<\/td><td>SARS-CoV-2<\/td><td>&nbsp;<\/td><td>SARS-CoV-2<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>T21<\/td><td>SARS-CoV-2<\/td><td>&nbsp;<\/td><td>SARS-CoV-2<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>T22<\/td><td>Covid-19<\/td><td>&nbsp;<\/td><td>Covid-19<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>T23<\/td><td>None<\/td><td>&nbsp;<\/td><td>Albumin<\/td><td>&nbsp;<\/td><td>98% accurate<\/td><td>3 minutes<\/td><\/tr><tr><td>T24<\/td><td>Underactive thyroid<\/td><td>&nbsp;<\/td><td>TSH<\/td><td>&nbsp;<\/td><td>98% accurate<\/td><td>3 minutes<\/td><\/tr><tr><td>T25<\/td><td>Iron deficiency<\/td><td>&nbsp;<\/td><td>Ferritin<\/td><td>&nbsp;<\/td><td>95% accurate<\/td><td>5 minutes<\/td><\/tr><tr><td>T26<\/td><td>Iron deficiency<\/td><td>&nbsp;<\/td><td>Ferritin<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>5 minutes<\/td><\/tr><tr><td>T27<\/td><td>Vitamin D deficiency<\/td><td>&nbsp;<\/td><td>Vit D<\/td><td>&nbsp;<\/td><td>Clinically tested accuracy<\/td><td>10 minutes<\/td><\/tr><tr><td>T28<\/td><td>Vitamin D deficiency<\/td><td>&nbsp;<\/td><td>25-hydroxy Vit D<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>10 minutes<\/td><\/tr><tr><td>T29<\/td><td>Cholesterol level<\/td><td>&nbsp;<\/td><td>Cholesterol level<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>3 minutes<\/td><\/tr><tr><td>T30<\/td><td>Glucose<\/td><td>&nbsp;<\/td><td>Glucose<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Minutes*<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p id=\"p-27\">FSH=follicle stimulating hormone; PSA=prostate specific antigen; Strep=streptococcus; TSH=thyroid stimulating hormone; TTG=tissue transglutaminase.<\/p>\n\n\n\n<ul>\n<li>*\u00a0No specific duration specified.<\/li>\n<\/ul>\n\n\n\n<p><strong>Table 3<\/strong>&nbsp;<\/p>\n\n\n\n<p id=\"p-40\">Test interpretation and recommended actions<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>Test ID label: product name; result<\/th><th>Interpretation<\/th><th>Recommended medical contact<\/th><th>Treatment\/actions<\/th><th>Further tests<\/th><\/tr><\/thead><tbody><tr><td colspan=\"5\"><strong>T1: Menopause Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Assume that you have reached post menopause if both test results are positive<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Repeat the test a week later if first is positive<\/td><\/tr><tr><td>Negative<\/td><td>You have not yet reached post-menopause<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T2: Flourish Menopause Test Kit<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>You could be under menopausal process if both test results are positive<\/td><td>Gynaecologist<\/td><td>&nbsp;<\/td><td>Repeat the test 5-7 days later if first is positive<\/td><\/tr><tr><td>Negative<\/td><td>You are probably not under menopausal process<\/td><td>Gynaecologist<\/td><td>&nbsp;<\/td><td>Repeat test 40-60 days later if you still have symptoms<\/td><\/tr><tr><td colspan=\"5\"><strong>T3: Menopause (FSH) Rapid Test<\/strong><\/td><\/tr><tr><td>Perimenopausal symptoms:<\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>\u2003Positive<\/td><td>Most likely (two positive test results) or may be in perimenopause (one positive test)<\/td><td>Doctor<\/td><td>Do not immediately discontinue contraception<\/td><td>&nbsp;<\/td><\/tr><tr><td>\u2003Negative<\/td><td>Most likely not experiencing perimenopause<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>Test can be repeated<\/td><\/tr><tr><td>Menopausal symptoms:<\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>\u2003Positive<\/td><td>Menopause has most likely occurred (after one positive test)<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>\u2003Negative<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Repeat testing in following month if still have symptoms<\/td><\/tr><tr><td colspan=\"5\"><strong>T4: FSH Rapid Menopause Test Midstream<\/strong><\/td><\/tr><tr><td>Perimenopausal symptoms:<\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>\u2003Positive<\/td><td>Most likely (two positive test results) or may be in perimenopause (one positive test)<\/td><td>Doctor<\/td><td>Do not immediately discontinue contraception<\/td><td>&nbsp;<\/td><\/tr><tr><td>\u2003Negative<\/td><td>Most likely not experiencing perimenopause<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>Test can be repeated<\/td><\/tr><tr><td>Menopausal symptoms:<\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>\u2003Positive<\/td><td>Menopause has most likely occurred (one positive test)<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>\u2003Negative<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Repeat testing in following month if still have symptoms<\/td><\/tr><tr><td colspan=\"5\"><strong>T5: SP-10 Male Fertility Rapid Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Sperm concentration is less than 15 million\/mL<\/td><td>Expert medical advice<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>Sperm concentration is above 15 million\/mL<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T6: SpermCheck Fertility<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Sperm count concentration is less than 15 million\/mL<\/td><td>Doctor<\/td><td>Possible treatment for subfertility as advised by doctor<\/td><td>Complete semen analysis<\/td><\/tr><tr><td>Negative<\/td><td>Sperm count is at least 15 million\/mL<\/td><td>Doctor if still experiencing fertility issues<\/td><td>&nbsp;<\/td><td>Complete semen analysis and fertility evaluation for partner<\/td><\/tr><tr><td colspan=\"5\"><strong>T7: SwimCount Sperm Quality Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>PMSC concentration is lower than for fertile men; may be unable to get your partner pregnant naturally<\/td><td>Doctor<\/td><td>Lifestyle changes to improve sperm concentration<\/td><td>Repeat test in three months after lifestyle changes<\/td><\/tr><tr><td>Negative<\/td><td>PMSC concentration is normal; high chance making partner pregnant naturally<\/td><td>Doctor if still experiencing fertility issues<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T8: SURE CHECK HIV Self-Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Probably HIV positive<\/td><td>Doctor<\/td><td>Protect yourself and others<\/td><td>Confirmatory laboratory test<\/td><\/tr><tr><td>Negative<\/td><td>Probably HIV negative<\/td><td>Doctor if possibility of being in the seroconversion period<\/td><td>&nbsp;<\/td><td>Repeat the test in 3 months if possible exposure to HIV<\/td><\/tr><tr><td colspan=\"5\"><strong>T9: Female Chlamydia STI Test Kit<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>&nbsp;<\/td><td>Doctor<\/td><td>Sexual partner should also take a test and undergo treatment<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>Highly unlikely to have chlamydia<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Regular testing recommended<\/td><\/tr><tr><td colspan=\"5\"><strong>T10: Women\u2019s Intimate Self-test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Vaginal pH is higher than normal; probably have bacterial vaginosis\/trichomoniasis dependent on symptoms<\/td><td>Pharmacist if bacterial vaginosis suspected; doctor if trichomoniasis suspected<\/td><td>Product for bacterial vaginosis from pharmacist; treatment for trichomoniasis from doctor<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>Vaginal pH is normal; probably have thrush if symptoms are present<\/td><td>Pharmacist if thrush is suspected<\/td><td>Products for thrush advised by pharmacist<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T11: Canestest Self-test for Vaginal Infections<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Vaginal pH is higher than normal; probably have bacterial vaginosis\/trichomoniasis infection dependent on symptoms<\/td><td>Pharmacist if bacterial vaginosis suspected; doctor if trichomoniasis suspected or if no symptoms<\/td><td>Treatment for bacterial vaginosis from pharmacist or doctor; trichomoniasis from doctor<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>Vaginal pH is normal; probably have thrush if symptoms are present<\/td><td>Pharmacist if thrush suspected<\/td><td>Over-the-counter thrush products<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T12: Urine Infection Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Likely that something is wrong with your urine<\/td><td>GP<\/td><td>&nbsp;<\/td><td>Further investigation by GP<\/td><\/tr><tr><td>Negative<\/td><td>&nbsp;<\/td><td>Doctor if symptoms persist<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T13: Bowel Health Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Blood detected in stool<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>No blood detected in stool (does not exclude possibility of bowel condition)<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Test yourself or arrange to be tested annually from age 40 years<\/td><\/tr><tr><td colspan=\"5\"><strong>T14: FOB Rapid Test (Faeces)<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Blood in faeces does not necessarily indicate colorectal bleeding<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T15: Prostate Health Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>PSA level is higher than normal (4 ng\/mL)<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>PSA level is in the normal range<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Regular testing if between 50 and 75 years of family history<\/td><\/tr><tr><td colspan=\"5\"><strong>T16: Stomach Ulcer Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td><em>H. pylori<\/em>&nbsp;antibodies detected<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>No&nbsp;<em>H. pylori<\/em>&nbsp;antibodies detected<\/td><td>Doctor if symptoms persist<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T17: Gluten Sensitivity Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Anti-t-TG IgA type antibodies are present<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>No anti-t-TG IgA type antibodies detected<\/td><td>Doctor if symptoms persist<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T18: One step Strep A Swab test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>May be in a stage of Strep A infection<\/td><td>Doctor<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>Concentration of Strep A antigen is zero or below detection limit (probably not infected)<\/td><td>Doctor if symptoms persist or experience serious complications<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T19: Flowflex Influenza A\/B Rapid Test (Self-Testing)<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Influenza A or B antigen detected<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Alternative confirmatory tests<\/td><\/tr><tr><td>Negative<\/td><td>No influenza or A\/B antigen detected (does not preclude influenza or other infections)<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>Alternative confirmatory tests<\/td><\/tr><tr><td colspan=\"5\"><strong>T20: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Presence of SARS-CoV-2 antigen; very likely infected with covid-19<\/td><td>Doctor<\/td><td>Follow self-isolation rules; contact local health department<\/td><td>PCR test<\/td><\/tr><tr><td>Negative<\/td><td>Unlikely to currently have covid-19; infection may still be present (does not rule out other infections)<\/td><td>&nbsp;<\/td><td>Follow current rules<\/td><td>Repeat test after 1-2 days if infection suspected; molecular assay if necessary<\/td><\/tr><tr><td colspan=\"5\"><strong>T21: One step test for SARS-CoV-2 Antigen (Colloidal Gold)<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Presence of SARS-CoV-2 antigen; likely to have covid-19<\/td><td>Doctor<\/td><td>Follow self-isolation rules; contact local health department<\/td><td>Molecular testing<\/td><\/tr><tr><td>Negative<\/td><td>No SARS-CoV-2 antigen detected; unlikely to be infected with covid-19; there may still be an infection<\/td><td>&nbsp;<\/td><td>Follow current rules<\/td><td>Repeat test after 1-2 days if infection suspected or with a molecular assay<\/td><\/tr><tr><td colspan=\"5\"><strong>T22: STEPAHEAD COVID-19 Antigen Rapid Test Kit (Swab) For Self-Testing<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Presence of SARS-CoV-2; suspicion of covid-19 infection<\/td><td>Doctor<\/td><td>Follow self-isolation rules; contact local health department<\/td><td>PCR test<\/td><\/tr><tr><td>Negative<\/td><td>Does not preclude SARS-CoV-2 infection; there may still be an infection<\/td><td>Healthcare provider if still experiencing covid-like symptoms<\/td><td>Follow current rules<\/td><td>Repeat test after 1-2 days if infection suspected<\/td><\/tr><tr><td colspan=\"5\"><strong>T23: Microalbuminuria (MAU) Rapid Test Kit (Colloidal Gold)<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Albumin in urine is more than 20 mg\/L (does not necessarily indicate kidney injury)<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td>Negative<\/td><td>Albumin in urine is less than the cutoff value<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T24: TSH Rapid Test Cassette<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>TSH level is higher than normal (5 \u03bcIU\/mL) (indicates an underactive thyroid (hypothyroidism))<\/td><td>Physician; repeatedly abnormal results discussed with doctor<\/td><td>&nbsp;<\/td><td>Further tests decided by physician; quantitative laboratory TSH assay<\/td><\/tr><tr><td>Negative<\/td><td>TSH below 5 \u03bcIU\/mL within normal range (not in range to consider hypothyroidism; hyperthyroidism cannot be excluded)<\/td><td>Physician if symptoms persist<\/td><td>&nbsp;<\/td><td>Quantitative laboratory TSH assay<\/td><\/tr><tr><td colspan=\"5\"><strong>T25: Ferritin Rapid Test Cassette<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Ferritin concentration in blood is lower than 30 ng\/mL; possible iron deficiency<\/td><td>Physician; repeatedly abnormal results discussed with doctor<\/td><td>&nbsp;<\/td><td>Tests decided by physician; use a secondary analytical method<\/td><\/tr><tr><td>Negative<\/td><td>Ferritin higher than 30 ng\/mL and within normal range; no potential iron deficiency<\/td><td>Physician if symptoms persist<\/td><td>&nbsp;<\/td><td>Use a secondary analytical method<\/td><\/tr><tr><td><strong>T26: Iron Deficiency<\/strong><\/td><td><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr><td>Positive<\/td><td>Ferritin concentration in blood is lower than 30 ng\/mL; possible iron deficiency<\/td><td>Physician; repeatedly abnormal results discussed with doctor<\/td><td>&nbsp;<\/td><td>Tests decided by physician; use a secondary analytical method<\/td><\/tr><tr><td>Negative<\/td><td>Ferritin higher than 30 ng\/mL and within normal range; no potential iron deficiency<\/td><td>Physician if symptoms persist<\/td><td>&nbsp;<\/td><td>Use a secondary analytical method<\/td><\/tr><tr><td colspan=\"5\"><strong>T27: Vitamin D Rapid Test Cassette<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Vitamin D level is less than 30 ng\/mL (deficient or insufficient)<\/td><td>Physician if result is deficient, insufficient, or excess<\/td><td>Vitamin D supplements<\/td><td>Tests decided by physician; use a secondary analytical method<\/td><\/tr><tr><td>Negative<\/td><td>Vitamin D level is higher than or equal to 30 ng\/mL and within normal range<\/td><td>Physician if symptoms persist<\/td><td>&nbsp;<\/td><td>Use a secondary analytical method<\/td><\/tr><tr><td colspan=\"5\"><strong>T28: Vitamin D Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Vitamin D level is less than 30 ng\/mL (deficient or insufficient)<\/td><td>Physician if result is deficient, insufficient, or excess<\/td><td>Vitamin D supplements<\/td><td>Tests decided by physician; use a secondary analytical method<\/td><\/tr><tr><td>Negative<\/td><td>Vitamin D level is higher than or equal to 30 ng\/mL and within normal range<\/td><td>Physician if symptoms persist<\/td><td>&nbsp;<\/td><td>Secondary analytical method<\/td><\/tr><tr><td colspan=\"5\"><strong>T29: Cholesterol Level Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Cholesterol level is probably high if above 5.2 mmol\/L<\/td><td>Doctor<\/td><td>Treatment as advised by doctor<\/td><td>Further tests as decided by doctor<\/td><\/tr><tr><td>Negative<\/td><td>Cholesterol is probably normal if level is less than 5.2 mmol\/L<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><td>&nbsp;<\/td><\/tr><tr><td colspan=\"5\"><strong>T30: Blood Glucose Test<\/strong><\/td><\/tr><tr><td>Positive<\/td><td>Below 3.9 or above 6.1 mmol\/L blood sugar level is outside the normal range<\/td><td>Doctor if both tests are abnormal<\/td><td>&nbsp;<\/td><td>Repeat test on a different day; detailed assessment by doctor<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p id=\"p-41\">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.<\/p>\n\n\n\n<p id=\"p-7\"><strong>Conclusions<\/strong>&nbsp;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.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Research Direct-to-consumer self-tests sold in the UK i [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/28861"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=28861"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/28861\/revisions"}],"predecessor-version":[{"id":28862,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/28861\/revisions\/28862"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=28861"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=28861"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=28861"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}