InteliSwab COVID-19 Rapid Test Instruction Manual
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InteliSwab COVID-19 Rapid Test - Instructions for Use Home Testing
InteliSwab COVID-19 Rapid Test - US Food and Drug ...
device and a tube, Instructions for Use. (in English and Spanish), Positive Result. Reference Card and test stand. Pick up the two-part pouch.
INSTRUCTIONS FOR USE SCAN HERE FOR STEP-BY …
INSTRUCTIONS FOR USE You must follow the test directions carefully to get an accurate result. Call OraSure Technologies at 1-833-601-0127 or visit www.InteliSwab.com to obtain the complete ...
Extracted Text
INSTRUCTIONS FOR USE You must follow the test directions carefully to get an accurate result. Call OraSure Technologies at 1-833-601-0127 or visit www.InteliSwab.com to obtain the complete instructions for use. FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY. IMPORTANT: Swabbing the nostrils is critical for obtaining an accurate result. If you do not swab your nose, the device will produce a false negative result. HOW TO USE THE INTELISWABTM COVID-19 RAPID TEST SCAN HERE FOR STEP-BY-STEP VIDEO ENGLISH 1 2 3 4 5 6 7 8 DO NOT 00:30 pour out the liquid START STOP TIMER SET TIMER 20 sec. FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY 01-3378 234567 017-06 FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY Hold tube 01-3378 234567 upright 017-06 C T PACNEKAPGAESNDOMIDEAONSNTNPAYOAGVTREEEARKACTONSPUACNMIEKRAPGAESDNMIOANDENOTSAYNGPOEATREAACTON DEV SOL VIAL 01-3378 234567 017-06 YOU WILL NEED A WAY TO TIME THE TEST. Wash your hands thoroughly with soap and water for 20 seconds before starting the test. Kit Contains: pouched device(s) with a device and a tube, Instructions for Use (in English and Spanish), Positive Result Reference Card and test stand. Pick up the two-part pouch. Tear open the pouch containing the tube and remove. With the tube in an upright position, gently rock the cap back and forth to remove it. DO NOT twist. DO NOT pour out the liquid. DO NOT drink. Slide the tube into the test stand on a flat sturdy surface. DO NOT force from the front as splashing may occur. Tube should rest at an angle on the bottom of the stand. If the solution spills, you will need a new test. Blow your nose into a tissue. If assisting someone, instruct them to blow their nose. DO NOT use tissue to clear out nasal passage. Discard tissue and wash hands thoroughly. Dry hands before starting the collection. FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY Test device Result window C T Flat pad C T 9 THROW AWAY preservative. NOT needed for the test. DO NOT EAT. T C C T 15 15 times AND times Fig. 1 Fig. 2 10 11 Make sure the C T 10 times tube and device C T are at an angle 012-33043157768-706 01-3378 234567 017-06 30 minutes 12 30 Wait 40 30 Read Tear open the pouch containing the test device and remove. DO NOT touch the flat pad with your fingers. DO NOT eat or swallow the preservative. If the preservative is not present, DO NOT use the test. Insert flat pad of the device inside the nostril. Circle around the nostril 15 times while maintaining contact with the inside wall of the nostril. SWAB BOTH NOSTRILS (Fig. 1 and Fig. 2). If you are conducting the test on someone who requires assistance, proceed by swabbing the individual. If you do not swab both nostrils 15 times each, you may get a false result. INTERPRETING RESULTS: Read test results in a well-lit area. Hold the test stand on a flat surface and insert the flat pad of the device into the tube. Stir 10 times to mix the sample with the liquid in the tube. Make sure the flat pad is toward the back of the tube so it contacts the liquid. Swirling the device less than 10 times may cause invalid results. After mixing, leave the device in the tube. Make sure the flat pad is touching the bottom of the tube and the result window is facing you. Start your timer for 30 minutes. DO NOT remove the device from tube while the test is running. A pink background will pass through the result window as the test is working. Read results between 30 and 40 minutes. To obtain an accurate result, DO NOT read before 30 minutes or after 40 minutes. Reading before 30 minutes may cause false negative results. Note: The line next to the "C" does not show that an adequate sample has been collected. POSITIVE RESULT The test is POSITIVE if: there is a reddish-purple line next to the "T" and NO reddish-purple line next to the "C" there is a reddish-purple line next to the "T" and a reddish-purple line next to the "C", even if the "C" line is faint there is a faint reddish-purple line next to the "T" and a reddish-purple line next to the "C" You need to self-isolate so you do not infect others. You may need additional testing, depending on your personal health history and other factors. Refer to the Positive Result Reference Card provided for more examples of positive test results. This card will help you see how faint the test line can appear. NEGATIVE RESULT READING BEFORE 30 MINUTES MAY CAUSE A FALSE NEGATIVE RESULT. The test is NEGATIVE if: there is a reddish-purple line next to the "C" and NO reddish-purple line next to the "T" Next Steps . . . As soon as possible . . . Call your healthcare provider to report your result. If you have emergency warning signs such as trouble breathing, persistent pain or pressure in the chest, new confusion, inability to wake or stay awake or bluish lips or face, call 911 or go to the closest Emergency Room. There must be a line next to the "C" to be able to interpret a negative result. If you have COVID-19 symptoms and your test result is negative, you likely do not have COVID-19. If you DO NOT have COVID-19 symptoms and your result is negative, you should test again in 24 to 48 hours. If both your first an second test results are negative, you may not have COVID-19. Call your healthcare provider to report your result. If your result is negative but you have signs and symptoms of COVID-19, contact your healthcare provider for additional testing. INVALID RESULT The test is not working and should be repeated if: no lines are present the line next to the "T" or the line next to the "C" is not complete (all the way across the window), or a reddish-purple background makes it impossible to read the test after 30 minutes You will need to obtain another test. The test did NOT work properly. Contact OraSure Technologies, Inc. at 1-833-601-0127 NOT SURE OF YOUR RESULT If you do not know your result or you are unsure of your result, contact OraSure Technologies at 1-833-601-0127 or go to www.InteliSwab.com DISPOSE Remove the test device from the tube, put the cap back on the tube and throw away in normal trash. If you have a 2-pack test kit, KEEP THE TEST STAND AND INSTRUCTIONS FOR COMPLETING ADDITIONAL TEST PROVIDED IN THE KIT. Once all devices have been used for testing, throw away all contents. D Do NOT Reuse Item #3001-3570-70 rev. 10/21 INTENDED USE The InteliSwabTM COVID-19 Rapid Test is a lateral flow immunoassay with an integrated swab, intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older, or adult collected anterior nasal swab samples from individuals aged 15 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The InteliSwabTM COVID-19 Rapid Test does not differentiate between SARS-CoV-1 and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the InteliSwab COVID-19 Rapid Test should self-isolate and seek followup care with their physician or healthcare provider as additional testing may be necessary. Negative results should be treated as presumptive and confirmation with molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection. Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their healthcare provider. Individuals should report all results obtained with this product to their healthcare provider for public health reporting. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the HYPERLINK "https://www.cdc.gov/csels/dls/sarscov-2-livd-codes.html" Laboratory In Vitro Diagnostics (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The InteliSwab COVID-19 Rapid Test is intended for nonprescription self-use and/or as applicable for an adult lay user testing another person 15 years of age or older in a non-laboratory setting. The InteliSwab COVID-19 Rapid Test is only for use under the Food and Drug Administration's Emergency Use Authorization. IMPORTANT DO'S AND DON'TS DO: Use the InteliSwabTM COVID-19 Rapid Test for testing for COVID-19 infection. Follow the Instructions for Use (reverse side) to obtain accurate results. Inadequate sampling may result in false results. Inspect the divided pouch. If the divided pouch has been damaged, discard the divided pouch and its contents. The results from the InteliSwabTM COVID-19 Rapid Test may not be valid if the divided pouch is damaged. Use adequate lighting to read a test result. Use the test device and tube containing fluid only once and dispose of both properly. Wash hands thoroughly prior to testing and after use. Report all test results (whether positive or negative) to your healthcare provider. Store the InteliSwabTM COVID-19 Rapid Test in a dry location between 35�-86�F (2�-30�C). Bring the divided pouch to room temperature (within 59�-104�F, 15�-40�C) before opening. Keep out of reach of children. DO NOT: DO NOT USE the InteliSwabTM COVID-19 Rapid Test on children under the age of 15. An adult must perform this test on children between the ages of 15 and 17. DO NOT USE the InteliSwabTM COVID-19 Rapid Test beyond the expiration date. DO NOT USE if the packaging has been opened or damaged. DO NOT OPEN the divided pouch until you are ready to start the test. DO NOT REUSE the test device or tube. IMPORTANT INFORMATION ABOUT THE INTELISWABTM COVID-19 RAPID TEST For consumer over-the-counter use. The InteliSwabTM COVID-19 Rapid Test is for the detection of the antigen associated with COVID-19, not for any other viruses or pathogens. Invalid results can occur if the sample and the reagents do not flow up the test device. The presence of a line next to the "C" does not indicate that an adequate sample was collected during the swabbing of the nostrils. The InteliSwabTM COVID-19 Rapid Test is for use under Emergency Use Authorization (EUA) only. This product has not been FDA cleared or approved, but has been authorized by FDA under EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act; 21 U.S.C. � 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. FREQUENTLY ASKED QUESTIONS What is COVID-19? COVID-19 (coronavirus disease 2019) is a contagious virus that may cause mild to severe respiratory illness, affecting other organs and systems potentially resulting in hospitalization or death. The presence of a specific antigen (the SARS-CoV-2 nucleocapsid protein antigen) indicates that an individual is currently infected with COVID-19 (even without the presence of symptoms) and can transmit the virus. What are common symptoms of COVID-19? Symptoms of COVID-19 may appear 2-14 days after exposure and may include fever, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, or a runny nose, nausea or vomiting and diarrhea. It is also possible for someone infected with COVID-19 to have no symptoms. What is the difference between a COVID-19 antigen test and a molecular test? There are different kinds of tests for diagnosing COVID-19. The InteliSwabTM COVID-19 Rapid Test is an antigen test. Antigen tests detect proteins, small parts, from the SARS-CoV-2 virus. Antigen tests are designed to detect virus levels that reflect active infection. Molecular tests (also known as PCR tests) detect genetic material from the virus (RNA). Antigen tests are less sensitive than molecular tests. If you have symptoms and your test is negative, you should discuss with your healthcare provider if additional testing is necessary. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19. What is serial testing? COVID-19 serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. Serial testing (i.e. testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms. If you do not have symptoms, testing should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing. Serial testing is not required for individuals with COVID-19 like symptoms that are within 7 days of symptom onset. What are the known and potential risks and benefits of this test? Potential risks include: Possible discomfort during sample collection. Possible incorrect results. Potential benefits include: The results, along with other information, can help your healthcare provider make informed recommendations about your care. The results of this test may help limit the spread of COVID-19 to your family and others in your community. How accurate is the InteliSwabTM COVID-19 Rapid Test? The InteliSwabTM COVID-19 Rapid Test is a lateral flow in vitro diagnostic antigen test to detect COVID-19. Antigen tests are designed to detect active infection in individuals. A clinical study was conducted during February and April of 2021 to determine the performance of the InteliSwabTM COVID-19 Rapid Test. A total of 146 individuals with signs and symptoms of COVID-19 within the first 7 days of symptom onset were enrolled across 5 different locations in the US. Subjects 18 years or older independently collected the lower nasal sample and completed the home use test. The InteliSwabTM COVID-19 Rapid Test results were compared to highly sensitive molecular FDA Authorized SARS-CoV-2 assays to determine test performance. The InteliSwabTM COVID-19 Rapid Test correctly identified 84% of the positive samples. Additionally, the InteliSwabTM COVID-19 Rapid Test correctly identified 98% of negative samples. What if you test positive? A positive result means that it is very likely you have COVID-19 and it is important to report your results to your healthcare provider. You should isolate yourself at home to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (false positive). Information about Emergency Use Authorizations and COVID-19? For more information on EUAs go here: https:// www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policyframework/emergency-use-authorization. For the most up to date information on COVID-19, please visit: www.cdc.gov/ COVID19 Visit InteliSwab.com to obtain the complete Instructions for Use and Fact Sheets. What if you test negative? If you have symptoms, you likely do not have COVID-19. If you do not have symptoms and you receive a second negative result 24 to 48 hours after your first negative result, then you are likely not infected with COVID-19. If you have symptoms, you may have a different virus or type of infection. You may have COVID-19 and still get a negative result (false negative) if: You didn't perform the test correctly, such as not swabbing correctly or not waiting 30 minutes for test results. The level of antigen from the COVID-19 virus was below the test limits. You have had signs and symptoms of COVID-19 for more than 7 days. This means you could still possibly have COVID-19 even though the test is negative. Please see your health care provider. Your healthcare provider will consider the test result along with all other aspects of your medical history, including your symptoms and possible COVID-19 exposures to decide how to care for you. It is important for you to work with your healthcare provider to help you understand the next steps you should take. A different type of test might be necessary to determine whether or not you have COVID-19. The performance of this test was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARSCoV-2 and their prevalence, which change over time. Why do I have a test line and no control line? If you have a test line and no control line, your test is positive. When the level of virus in the sample is high, the line next to the "C" may not be present or may be very faint. The line next to the "C" must be visible to read a negative test result. Please see the other side of this Instructions for Use and the enclosed reference card to help you understand how to interpret test results. Will this test hurt? No. The nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider. Is the solution in the tube harmful? No. The solution in the tube contains potentially harmful chemicals (Triton X-100 and ProClin 950); however, laboratory studies have shown them to be nontoxic at the levels contained in the solution. The developer solution should only be used as directed; do not ingest; keep out of the reach of children; avoid contact with skin and eyes. If the solution contacts the skin or eye, flush with copious amounts of water. If irritation persists, seek medical advice: https://www.poison.org/ contact-us or 1-800-222-1222. SWAB both nostrils SWIRL in the tube SEE your results EXPLANATION OF SYMBOLS MORE QUESTIONS ABOUT THE INTELISWABTM COVID-19 RAPID TEST? If you have any questions about the InteliSwabTM COVID-19 Rapid Test, please contact our toll-free consumer helpline at 1-833-601-0127 or visit www.InteliSwab.com. The InteliSwabTM COVID-19 Rapid Test Letter of Authorization, authorized Fact Sheets and authorized labeling are available on the FDA website and www.InteliSwab.com. SCAN HERE FOR STEP-BY-STEP VIDEO: OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 USA (610) 882-1820 www.OraSure.com � 2021 OraSure Technologies, Inc. 3001-3570 rev. 10/21 POSITIVE TEST RESULTS ADDITIONAL REFERENCE IMAGES This card provides additional examples of what a positive result could look like. Use the Instructions for Use included in the box to complete your test. Upon completion, if you think you have a positive result but are unsure, please compare your test to the images below. EXAMPLES OF POSITIVE TEST RESULTS These photos show how faint the line next to the "T" may be. These are all positive test results. In some cases, the line next to the "C" may be very faint. Look very closely! The bottom line may be very faint. T Any line next to the "T" means you may have COVID-19, even if the line is very faint. THE TEST RESULT IS ALSO POSITIVE IF: There is a line next to the "T" and NO line next to the "C" If your test does not look like any of these, see Instructions for Use for more examples of test results. Be sure to follow all instructions. This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. � 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 3001-3528-70 Para obtener informaci�n en espa�ol, vea el reverso. rev. 06/21 � 2021 OraSure Technologies, Inc. 3001-3528 rev 06/21 Swirl in the tube SIMPLY SWAB, SWIRL AND SEE LEARN MORE - - - J- .-S-3- .-l- -L- - , TEST lnteliswab'" COVID-19 RAPID TEST HOME TEST RESULTS IN MINUTES SMART SCIENCE MADE SIMPLETM GENTLE SHALLOW NASAL SWAB lntelfswab COVID-19 RAPID TEST SIMPLE & CONVENIENT TESTING No assembly required - ready to use No waiting for mail or lab processing ANYTIME, ANYWHERE The lnteliSwab'" COVID-19 Rapid Test is for use under the Food and Drug Administration's Emergency Use Authorization only. This product has not been FDA cleared or approved, but has been authorized by FDA under an ELIA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(l) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. � 360bbb-3(b)(l), unless the declaration is terminated or authorization is revoked sooner. lnteltSwab� COVID-19 RAPID TEST lnstrucciones de use en espar'iol ubicadas dentro de la caja. The lnteliSwabTM COVID-19 Rapid Test detects active infection in individuals 15 years and older with symptoms within the first 7 days of onset or in individuals without symptoms when tested twice with at least 24 hours but no more than 48 hours between tests. See Instructions for Use for full intended use. QUICK AND EASY RESULTS Use at home or anywhere there is a flat surface No professional supervision or video consultation required No phone or other equipment needed to interpret results CONTENTS One (1) pouch with: � Single-use test device � Tube with developer fluid Instructions for Use in English and Spanish Positive Result Reference Card Test stand You will need a way to time the test for 30 minutes (a watch, clock or cellphone). If you have symptoms of COVID-19, you can use a single test. If you do not have symptoms of COVID-19, you will need at least two tests per person. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test. Store the lnteliSwab'M COVID-19 Rapid Test in a dry location between 35�-86� F (2�-30�C). QUESTIONS? Go to www.lnteliSwab.com or call 1-833-601-0127 &6'F & � mi 35�' Ill OraSure Technologies, Inc. 220 East First Street, Bethlehem, PA 18015 USA (+l) 610-882-1820 www.OraSure.com 2021 OraSure Technologies, Inc. 3001-3630 rev. 10/21 Item #3001-3630-70 rev. 10/21 Swirl in the [I..] tube r:esurlts SIMPLY SWAB, SWIRL AND SEE LEARN MORE - - S- -.1-S- 3- -.-1-Z- - - lntelTSw2aTEbSTSTM COVID-19 RAPID TEST HOME TEST RESULTS IN MINUTES SMART SCIENCE MADE SIMPLETM GENTLE SHALLOW NASAL SWAB lnteliswab� COVID-19 RAPID TEST SIMPLE & CONVENIENT TESTING No assembly required - ready to use No waiting for mail or lab processing ANYTIME, ANYWHERE The lnteliSwab'" COVID-19 Rapid Test is for use under the Food and Drug Administration's Emergency Use Authorization only. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(l) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. � 360bbb-3(b)(l), unless the declaration is terminated or authorization is revoked sooner. lnte�swab� lnstrucciones de use en espanol :-------!::=======-i_____________________----- - -,,------. ,._ _ COVID-19 RAPID TEST ubicadas dentro de la caja. The lnteliSwabTM COVID-79 Rapid Test detects active infection in individuals 15 years and older with symptoms within the first 7 days of onset or in individuals without symptoms when tested twice with at least 24 hours but no more than 48 hours between tests. See Instructions for Use for full intended use. QUICK AND EASY RESULTS � Use at home or anywhere there is a flat surface No professional supervision or video consultation required � No phone or other equipment needed to interpret results CONTENTS Two (2) pouches, each with: � Single-use test device � Tube with developer fluid Instructions for Use in English and Spanish Positive Result Reference Card Test stand You will need a way to time the test for 30 minutes (a watch, clock or cellphone). If you have symptoms of COVID-19, you can use a single test. If you do not have symptoms of COVID-19, you will need at least two tests per person. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test. Store the lnteliSwab'" COVID-19 Rapid Test in a dry location between 35�-86� F (2�-30�C). QUESTIONS? Go to www.lnteliSwab.com or call 1-833-601-0127 86�F � mi 6 35�' � OraSure Technologies, Inc. 220 East First Street, Bethlehem, PA 18015 USA (+1) 610-882-1820 www.OraSure.com @ 2021 OraSure Technologies, Inc. 3001-3581 rev. 10/21 Item #3001-3581-70 rev. 10/21