{"product_id":"accutest-valupak-strep-a-test-strip-id713","title":"Accutest VALUPAK, Strep A Test Strip, 25 Tests\/Box (ID713)","description":"\u003cp\u003eAccutest VALUPAK, Strep A Test Strip (ID713) 1 Box, 25 Tests\/Box\u003c\/p\u003e\n\u003cp\u003e**This item is intended for professional use only and are \u003cstrong\u003enot\u003c\/strong\u003e approved for personal use or ship to a residential address. At checkout, please provide a medical \/ healthcare practice name and address for order processing.**\u003c\/p\u003e\n\u003cp\u003eThe Accutest® VALUPAK™ Strep A Test Strip is a CLIA-waived rapid immunoassay for the qualitative detection of Group A Streptococcal antigen in throat swab specimens from symptomatic patients. This convenient strip-format test provides results in 5 minutes and includes 25 tests per box. Negative results are presumptive and should be confirmed by bacterial culture.\u003c\/p\u003e\n\u003ch2 class=\"uppercase\"\u003eKit Contents\u003c\/h2\u003e\n\u003cdiv class=\"row\" id=\"row-676203470\"\u003e\n\u003cdiv id=\"col-1388357795\" class=\"col medium-6 small-12 large-6\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003cul\u003e\n\u003cli\u003e25 test strips\u003c\/li\u003e\n\u003cli\u003e25 sterile swabs\u003c\/li\u003e\n\u003cli\u003e25 disposable extraction tubes\u003c\/li\u003e\n\u003cli\u003eReagent A\u003c\/li\u003e\n\u003cli\u003eReagent B\u003c\/li\u003e\n\u003cli\u003ePositive external control\u003c\/li\u003e\n\u003cli\u003eNegative external control\u003c\/li\u003e\n\u003cli\u003eTwo tube holders\u003c\/li\u003e\n\u003cli\u003eInstructions for Use\u003c\/li\u003e\n\u003cli\u003eQuick Reference Instructions\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ch2 class=\"uppercase\"\u003eProduct Overview\u003c\/h2\u003e\n\u003cp\u003eThe \u003cstrong\u003eAccutest® VALUPAK™ Strep A Test Strip\u003c\/strong\u003e is a rapid chromatographic immunoassay for the qualitative detection of \u003cem\u003eStreptococcus pyogenes\u003c\/em\u003e (Group A β-hemolytic Streptococcus) antigen in throat swab specimens from symptomatic patients. The test is intended to aid in the diagnosis of Group A Streptococcal bacterial infection.\u003c\/p\u003e\n\u003cp\u003eA throat swab specimen is treated with Reagent A and Reagent B in the provided extraction tube. The test strip is then placed into the extracted specimen, and results are read at 5 minutes. A colored control line confirms that the test has performed correctly, while the appearance of both a control line and a test line indicates a positive result.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eNegative results are presumptive and should be confirmed by bacterial culture.\u003c\/strong\u003e Test results should be evaluated together with the patient’s symptoms and other clinical information.\u003c\/p\u003e\n\u003csection class=\"section\" id=\"section_279109502\"\u003e\n\u003cdiv class=\"section-bg fill\"\u003e\u003cimg\u003e\u003c\/div\u003e\n\u003cdiv class=\"section-bg fill\"\u003e\u003cimg src=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0711\/6737\/7624\/files\/ID713StrepAtrst.png?v=1792249587\" alt=\"\"\u003e\u003c\/div\u003e\n\u003cdiv class=\"section-content relative\"\u003e\n\u003cdiv class=\"row align-center\" id=\"row-775106106\"\u003e\n\u003cdiv id=\"col-745919280\" class=\"col medium-4 small-12 large-4\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003cdiv\u003e\n\u003ch3\u003e5-Minute Results\u003c\/h3\u003e\n\u003cp\u003eRapid qualitative detection of Group A Streptococcal antigen.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"col-1619418759\" class=\"col medium-4 small-12 large-4\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003cdiv\u003e\n\u003ch3\u003eCLIA Waived\u003c\/h3\u003e\n\u003cp\u003eDesigned for testing in eligible CLIA-waived healthcare settings.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"col-1193463498\" class=\"col medium-4 small-12 large-4\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003cdiv\u003e\n\u003ch3\u003e25 Tests per Box\u003c\/h3\u003e\n\u003cp\u003eIncludes test strips, swabs, extraction tubes, reagents and external controls.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"section\" id=\"section_694946765\"\u003e\n\u003cdiv class=\"section-bg fill\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"section-content relative\"\u003e\n\u003cdiv class=\"row align-center\" id=\"row-2120907217\"\u003e\n\u003cdiv id=\"col-205155871\" class=\"col medium-10 small-12 large-10\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003ch2 class=\"uppercase\"\u003eKey Features\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eRapid qualitative detection of Group A Streptococcal antigen\u003c\/li\u003e\n\u003cli\u003eResults read at 5 minutes\u003c\/li\u003e\n\u003cli\u003eCLIA waived\u003c\/li\u003e\n\u003cli\u003eConvenient test strip format\u003c\/li\u003e\n\u003cli\u003eUses direct throat swab specimens from symptomatic patients\u003c\/li\u003e\n\u003cli\u003e96.5% sensitivity and 99.5% specificity*\u003c\/li\u003e\n\u003cli\u003ePositive and negative external controls included\u003c\/li\u003e\n\u003cli\u003eStorage at 2–30°C (36–86°F)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cem\u003e*Compared with bacterial culture in the clinical performance study. Refer to the package insert for complete performance data, limitations, warnings and instructions.\u003c\/em\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"section\" id=\"section_1156263708\"\u003e\n\u003cdiv class=\"section-bg fill\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"section-content relative\"\u003e\n\u003cdiv class=\"row align-center\" id=\"row-1836716617\"\u003e\n\u003cdiv id=\"col-1689874739\" class=\"col medium-10 small-12 large-10\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003ch2 class=\"uppercase\"\u003eProduct Specifications\u003c\/h2\u003e\n\u003cdiv\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003eCatalog Number\u003c\/th\u003e\n\u003ctd\u003e\u003cstrong\u003eID713\u003c\/strong\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eProduct Name\u003c\/th\u003e\n\u003ctd\u003eAccutest® VALUPAK™ Strep A Test Strip\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eIntended Use\u003c\/th\u003e\n\u003ctd\u003eQualitative detection of Group A Streptococcal antigen\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eSpecimen Type\u003c\/th\u003e\n\u003ctd\u003eDirect throat swab from symptomatic patients\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Format\u003c\/th\u003e\n\u003ctd\u003eTest strip\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eResult Time\u003c\/th\u003e\n\u003ctd\u003eRead at 5 minutes; do not read before 5 minutes or after 10 minutes\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCLIA Complexity\u003c\/th\u003e\n\u003ctd\u003eWaived\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eRegulatory Use\u003c\/th\u003e\n\u003ctd\u003ePrescription, in vitro diagnostic use only\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eSensitivity\u003c\/th\u003e\n\u003ctd\u003e96.5%\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eSpecificity\u003c\/th\u003e\n\u003ctd\u003e99.5%\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eStorage\u003c\/th\u003e\n\u003ctd\u003e2–30°C (36–86°F); do not freeze\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003ePackage Size\u003c\/th\u003e\n\u003ctd\u003e25 tests per box\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eFDA 510(k)\u003c\/th\u003e\n\u003ctd\u003e\u003ca href=\"https:\/\/www.accessdata.fda.gov\/SCRIPTS\/CDRH\/CFDOCS\/cfClia\/Results.cfm?Document_Number=K212623\u0026amp;SortColumn=ded\u0026amp;start_search=1\" rel=\"noopener\" target=\"_blank\"\u003eK212623\u003c\/a\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"section\" id=\"section_1436807570\"\u003e\n\u003cdiv class=\"section-content relative\"\u003e\n\u003cdiv class=\"row align-center\" id=\"row-653962192\"\u003e\n\u003cdiv id=\"col-274966800\" class=\"col medium-10 small-12 large-10\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003cdiv class=\"row\" id=\"row-676203470\"\u003e\n\u003cdiv id=\"col-1388357795\" class=\"col medium-6 small-12 large-6\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"section\" id=\"section_1021715326\"\u003e\n\u003cdiv class=\"section-bg fill\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"section-content relative\"\u003e\n\u003cdiv class=\"row align-center\" id=\"row-1040620789\"\u003e\n\u003cdiv id=\"col-1584702894\" class=\"col medium-10 small-12 large-10\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003ch2 class=\"uppercase\"\u003eHow the Test Works\u003c\/h2\u003e\n\u003cp\u003eThe Accutest VALUPAK Strep A Test Strip is a qualitative lateral flow immunoassay that uses antibodies to detect Group A Streptococcal antigen in throat swab specimens.\u003c\/p\u003e\n\u003col\u003e\n\u003cli\u003eA throat swab specimen is collected using the sterile swab included in the kit.\u003c\/li\u003e\n\u003cli\u003eThe specimen is extracted using Reagent A and Reagent B in the provided extraction tube.\u003c\/li\u003e\n\u003cli\u003eThe test strip is placed into the extracted specimen.\u003c\/li\u003e\n\u003cli\u003eResults are read visually at 5 minutes.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003cp\u003eA visible control line indicates that the test has performed correctly. The appearance of both a control line and a test line indicates a positive result. If the control line does not appear, the result is invalid and the test should be repeated with a new test strip.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"section\" id=\"section_640976791\"\u003e\n\u003cdiv class=\"section-bg fill\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"section-content relative\"\u003e\n\u003cdiv class=\"row align-center\" id=\"row-528963043\"\u003e\n\u003cdiv id=\"col-1319351819\" class=\"col medium-10 small-12 large-10\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003ch3\u003eImportant Test Information\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eFor prescription, in vitro diagnostic use only.\u003c\/li\u003e\n\u003cli\u003eUse only the sterile swabs and reagents provided with the kit.\u003c\/li\u003e\n\u003cli\u003eRead results at 5 minutes. Do not read results before 5 minutes or after 10 minutes.\u003c\/li\u003e\n\u003cli\u003eNegative results are presumptive and should be confirmed by bacterial culture.\u003c\/li\u003e\n\u003cli\u003eAll results should be interpreted together with the patient’s symptoms and other available clinical information.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003ch2\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ctable width=\"100%\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003e What does the Accutest VALUPAK Strep A Test detect? \u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv id=\"accordion-2756790750\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-2756790750-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-2756790750-label\"\u003e\n\u003cp\u003eThe test qualitatively detects \u003cem\u003eStreptococcus pyogenes\u003c\/em\u003e, or Group A β-hemolytic Streptococcus, antigen in throat swab specimens from symptomatic patients.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003eWhat type of specimen is required?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv id=\"accordion-316043758\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-316043758-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-316043758-label\"\u003e\n\u003cp\u003eThe test is intended for use with direct throat swab specimens collected using the sterile swabs included in the kit.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003eHow quickly are results available?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv id=\"accordion-3329187038\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-3329187038-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-3329187038-label\"\u003e\n\u003cp\u003eResults are read at 5 minutes. Results should not be read before 5 minutes or after 10 minutes.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003eIs the Accutest VALUPAK Strep A Test CLIA Waived?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv id=\"accordion-2810904433\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-2810904433-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-2810904433-label\"\u003e\n\u003cp\u003eYes. The Accutest® VALUPAK™ Strep A Test Strip is categorized as CLIA waived. A Certificate of Waiver is required to perform the test in a CLIA-waived environment, and the manufacturer’s instructions must be followed.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003eWhat is included in each kit?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv id=\"accordion-3971191470\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-3971191470-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-3971191470-label\"\u003e\n\u003cp\u003eEach kit includes 25 test strips, 25 sterile swabs, 25 disposable extraction tubes, Reagent A, Reagent B, positive and negative external controls, two tube holders, Instructions for Use and Quick Reference Instructions.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003eHow should the test kit be stored?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv id=\"accordion-593480114\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-593480114-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-593480114-label\"\u003e\n\u003cp\u003eStore the kit in its original packaging at 2–30°C (36–86°F). Do not freeze any of the test components. Test strips must remain in their sealed pouches until use.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003eWhat does a negative result mean?\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv id=\"accordion-2153017864\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-2153017864-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-2153017864-label\"\u003e\n\u003cp\u003eA negative result means that Group A Streptococcal antigen was not detected in the specimen. Negative results are presumptive and should be confirmed by bacterial culture.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e\n\u003cp\u003e\u003cstrong\u003eIs this an over-the-counter home test?\u003c\/strong\u003e\u003c\/p\u003e\n\u003csection class=\"section\" id=\"section_1270415410\"\u003e\n\u003cdiv class=\"section-content relative\"\u003e\n\u003cdiv class=\"row align-center\" id=\"row-420732027\"\u003e\n\u003cdiv id=\"col-2084075604\" class=\"col medium-10 small-12 large-10\"\u003e\n\u003cdiv class=\"col-inner\"\u003e\n\u003cdiv class=\"accordion\"\u003e\n\u003cdiv id=\"accordion-2328245742\" class=\"accordion-item\"\u003e\n\u003cdiv id=\"accordion-2328245742-content\" class=\"accordion-inner\" aria-labelledby=\"accordion-2328245742-label\"\u003e\n\u003cp\u003eNo. The package insert identifies the Accutest® VALUPAK™ Strep A Test Strip as a prescription, in vitro diagnostic product.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/section\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/section\u003e","brand":"Jant Pharmacal","offers":[{"title":"Default Title","offer_id":52704527548632,"sku":"ID713","price":34.3,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0711\/6737\/7624\/files\/ID713.png?v=1792249705","url":"https:\/\/checkout.mdsupplies.com\/products\/accutest-valupak-strep-a-test-strip-id713","provider":"MDSupplies","version":"1.0","type":"link"}