{"product_id":"flowflex-covid-19-antigen-home-test-1-test-box","title":"Flowflex COVID-19 Antigen Home Test - 1 Test\/Box (IDL031118B5)","description":"\u003cp\u003eFlowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. For self-testing use. For use under an Emergency Use Authorization (EUA) only.\u003c\/p\u003e\n\u003ch2\u003e\u003cstrong\u003eFDA UPDATE:\u003c\/strong\u003e\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eFDA has granted 510(k) clearance for Flowflex and becomes the first FDA 510(k) for an OTC rapid antigen Covid test! The 510(k) version of Flowflex will be produced domestically.\u003c\/strong\u003e\u003c\/p\u003e\n\u003ch2\u003e\u003cstrong\u003eOMICRON UPDATE: Does Flowflex Detect Omicron?\u003c\/strong\u003e\u003c\/h2\u003e\n\u003cdiv\u003e\u003cstrong\u003eAn independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the\u003cspan\u003e \u003c\/span\u003e\u003cspan\u003eFlow\u003cem\u003eflex\u003c\/em\u003e™ COVID-19 Antigen Home Test does detect the Omicron subvariant BA.1 and BA.2 in live clinical samples\u003c\/span\u003e.\u003c\/strong\u003e\u003c\/div\u003e\n\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eClinical Performance:\u003c\/u\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe performance of Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19 and 64 asymptomatic patients. The Flowflex COVID-19 Antigen Home Test results were compared to an FDA EUA RT-PCR COVID-19 assay to determine test performance in the table below:\u003c\/p\u003e\n\u003cdiv class=\"text\" id=\"text-360705691\"\u003e\n\u003ctable cellpadding=\"0\" cellspacing=\"0\" border=\"1\" dir=\"ltr\"\u003e\n\u003ccolgroup\u003e \u003ccol width=\"220\"\u003e \u003ccol width=\"100\"\u003e \u003ccol width=\"100\"\u003e \u003ccol width=\"100\"\u003e \u003c\/colgroup\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Flowflex COVID-19 Antigen Home Test\"}'\u003e\n\u003ch1\u003e\u003cem\u003eFlowflex COVID-19 Antigen Home Test\u003c\/em\u003e\u003c\/h1\u003e\n\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"RT-PCR method\"}' rowspan=\"1\" colspan=\"3\"\u003e\u003cspan\u003e\u003cem\u003eRT-PCR method\u003c\/em\u003e\u003c\/span\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Positive\"}'\u003ePositive\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Negative\"}'\u003eNegative\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Total\"}'\u003eTotal\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Positive\"}'\u003e\u003cstrong\u003ePositive\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":39}'\u003e39\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":0}'\u003e0\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":39}'\u003e39\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Negative\"}'\u003e\u003cstrong\u003eNegative\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":3}'\u003e3\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":130}'\u003e130\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":133}'\u003e133\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Total\"}'\u003eTotal\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":42}'\u003e42\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":130}'\u003e130\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":3,\"3\":172}'\u003e172\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Positive Percent Agreement (PPA)\"}'\u003e\u003cstrong\u003ePositive Percent Agreement (PPA)\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"93% (95% CI: 81% -99%)\"}' rowspan=\"1\" colspan=\"3\"\u003e\n\u003cstrong\u003e93%\u003c\/strong\u003e\u003cspan\u003e \u003c\/span\u003e(95% CI: 81% -99%)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"Negative Percent Agreement (NPA)\"}'\u003e\u003cstrong\u003eNegative Percent Agreement (NPA)\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd data-sheets-value='{\"1\":2,\"2\":\"100% (95% CI: 97% - 100%)\"}' rowspan=\"1\" colspan=\"3\"\u003e\n\u003cstrong\u003e100%\u003c\/strong\u003e\u003cspan\u003e \u003c\/span\u003e(95% CI: 97% – 100%)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003cp\u003e\u003cstrong\u003eAnalytical Sensitivity: Limit of Detection (LoD):\u003cspan\u003e \u003c\/span\u003e\u003c\/strong\u003e\u003cspan\u003eLoD was determined as the lowest virus concentration that was detected ≥ 95% of the time. Based on this testing, the LoD in nasal matrix was confirmed to be 2.5 x 10\u003c\/span\u003e\u003csup\u003e3\u003c\/sup\u003e\u003cspan\u003e TCID\u003c\/span\u003e\u003csub\u003e50\u003c\/sub\u003e\u003cspan\u003e\/mL\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ca href=\"https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2.jpg\"\u003e\u003cimg srcset=\"https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-800x64.jpg 800w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-1400x112.jpg 1400w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-768x61.jpg 768w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-510x41.jpg 510w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2.jpg 1476w\" sizes=\"(max-width: 800px) 100vw, 800px\" data-ll-status=\"loaded\" data-lazy-src=\"https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-800x64.jpg\" data-lazy-sizes=\"(max-width: 800px) 100vw, 800px\" data-lazy-srcset=\"https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-800x64.jpg 800w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-1400x112.jpg 1400w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-768x61.jpg 768w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-510x41.jpg 510w, https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2.jpg 1476w\" height=\"64\" width=\"800\" alt=\"Flowflex COVID-19 Antigen Home Test\" src=\"https:\/\/www.jantdx.com\/wp-content\/uploads\/2021\/11\/Table2-800x64.jpg\" class=\"alignnone size-medium wp-image-69729 entered lazyloaded\" decoding=\"async\"\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003cdiv class=\"gap-element clearfix\" id=\"gap-361528389\"\u003e\u003c\/div\u003e\n\u003ch2\u003e\u003cspan\u003ePRODUCT DETAILS\u003c\/span\u003e\u003c\/h2\u003e\n\u003ctable width=\"662\"\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cstrong\u003eCatalog Number\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cstrong\u003eDescription\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd\u003e\u003cstrong\u003eUnits of Measurements\u003c\/strong\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eIDL031118B5\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003eFlow\u003cem\u003eflex\u003c\/em\u003e\u003csup\u003e®\u003c\/sup\u003e\u003cspan\u003e \u003c\/span\u003eCOVID-19 Antigen Home Test\u003c\/td\u003e\n\u003ctd\u003e 1 Test\/Kit\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eIDL031125M5\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003eFlow\u003cem\u003eflex\u003c\/em\u003e\u003csup\u003e®\u003c\/sup\u003e\u003cspan\u003e \u003c\/span\u003eCOVID-19 Antigen Home Test\u003c\/td\u003e\n\u003ctd\u003e 2 Tests\/Kit\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\u003cspan\u003eIDL031125P5\u003c\/span\u003e\u003c\/td\u003e\n\u003ctd\u003eFlow\u003cem\u003eflex\u003c\/em\u003e\u003csup\u003e®\u003c\/sup\u003e\u003cspan\u003e \u003c\/span\u003eCOVID-19 Antigen Home Test\u003c\/td\u003e\n\u003ctd\u003e 25 Tests\/Kit\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"Jant Pharmacal","offers":[{"title":"Default Title","offer_id":49804188123352,"sku":"IDL031118B5","price":8.31,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0711\/6737\/7624\/files\/682607660261-1-510x510.jpg?v=1734211372","url":"https:\/\/checkout.mdsupplies.com\/products\/flowflex-covid-19-antigen-home-test-1-test-box","provider":"MDSupplies","version":"1.0","type":"link"}