The Sure Check HIV Home Test has not been approved by the FDA, currently this test is an INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (or UNITED STATES) LAW TO INVESTIGATIONAL USE. RESULTS OF THIS TEST SHOULD NOT BE USED FOR DIAGNOSIS. SURE CHECK HIV HOME TEST Instruction Booklet
SURE CHECK AT HOME HIV TEST
CONTENTS WARNINGS AND PRECAUTIONS: HOW THE TEST WORKS MATERIALS PROVIDED IN THE POUCH THE TWO TEST PARTS GETTING STARTED COLLECTING THE BLOOD SAMPLE RUNNING THE TEST TEST RESULTS 1 2 3 4 5 6 7 11 14 Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
1. WARNINGS AND PRECAUTIONS: The SURE CHECK HIV Home Test is an in-vitro diagnostic test for HIV (HIV-1 and HIV-2) in fingerstick blood samples. This test works by looking for your body s response (antibodies) to fighting the HIV virus. IMPORTANT! Read through this Instruction Booklet and Information Booklet before beginning this test Please follow the testing directions in this Instruction Booklet carefully to be sure the results of your test are correct A positive result with this test does not mean that you are definitely infected with HIV, but that additional testing should be done in a medical setting A negative result with this test does not mean that you are definitely not infected with HIV, as you may have been exposed in the last 3 months. WARNINGS AND PRECAUTIONS: Most people feel a little bit anxious when taking an HIV test. But, if you feel very anxious about taking this test, you may want to wait until you are calmer to take it, or get tested by your doctor or a local clinic. If you are HIV positive or are on treatment or preventative treatment for HIV, this test is not meant for you. If the testing date for this test is past the expiration date printed on the outside of the box, do not use this test. I f you have someone helping you with the test, please be sure that the person is wearing medical exam gloves to avoid exposure to your blood. Make sure you are taking the test in a place with good lighting. Do not use the test if it has been stored outside the acceptable temperature of 46-86 F (8-30 C). If at any time you have questions, you can call the Support Center Toll Free phone number, 24 hours a day, 7 days a week at 1-800-000-0000. Your call is completely private and confidential.
HOW THE TEST WORKS 2. The SURE CHECK HIV Home Test will take 15 minutes to get a result. The test is performed by adding one drop of your blood to the test and looking for pink/red colored lines to read the result. There can be up to two pink/red lines on the test. The top colored line is the Control Line, which tells you that the test is working properly. The Control Line must always be present to get a correct result. If this line does not appear on the test strip, the result is Invalid and you should call the toll free number: 1-800-000-0000 for help. The Result Line below the Control Line tells you whether or not you might have HIV. Here are some examples: POSITIVE NEGATIVE CONTROL LINE RESULT LINE CONTROL LINE NO RESULT LINE Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
3. MATERIALS PROVIDED The SURE CHECK HIV Home Test Kit Here are all the materials needed to perform 1 test. The Sure Check At Home HIV test has not been approved by the FDA, currently this test is an INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (or UNITED STATES) LAW TO INVESIGATIONAL USE. RESULTS OF THIS TEST SHOULD NOT BE USED FOR DIAGNOSIS. SURE CHECK HIV HOME TEST n Pouch n Gauze Pad n Pencil To write your test time n Instruction Booklet n Alcohol Wipe n Finger Stick Device Use 1 time only n Test Holder Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
IN THE POUCH 4. Open pouch when ready to start test. n Pouch holds: Test Device, Drying Packet. n Drying Packet: Not used for testing. Packet keeps the contents dry. Should be thrown away. n Test Device with the Test Strip inside. Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
5. THE TWO TEST PARTS The SURE CHECK HIV HOME TEST has 2 parts: Test Holder with test liquid inside. Test Device with the test inside. Test Device Use these pictures to get to know the 2 test parts. Test Holder Test Liquid Blood Sample Tip NOTE: PICTURES ARE LARGER THAN ACTUAL SIZE Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
GETTING STARTED 6. Before starting the test, be sure to have all of the following items available and within easy reach: For Collecting the Blood Sample For Running and Timing the Test n Finger Stick Device YOU WILL NEED a Timing Device like a Clock or a Watch. n Test Device n Alcohol Wipe n Gauze Pad n Test Holder n Pencil n If you use eyeglasses to read, you should wear them to read the TEST RESULTS. n Make sure to read the test in a room with GOOD LIGHTING. n You will need a hard flat surface like a table. Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
7. COLLECTING THE BLOOD SAMPLE READ: STEPS (1-10) BEFORE BEGINNING THE TEST. Step 1 l Wash hands with soap and warm (not cold) water. l Rinse and dry completely before beginning the test. Step 2 l Open alcohol wipe and gauze pad. l Using your middle or ring finger, choose the finger stick area. (See shaded area in picture.) l Clean the fingertip with the alcohol wipe. Allow the finger to dry completely or wipe dry with the gauze pad. Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
COLLECTING THE BLOOD SAMPLE 8. Step 3 l Twist off tab of finger stick device. l Throw away tab. Step 4 l Put finger stick device firmly against the (middle or ring) finger as shown. l To take your blood sample, press finger stick device firmly against the finger (middle or ring finger) until you hear a CLICK. Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential. Go to next page now
9. COLLECTING THE BLOOD SAMPLE Step 5 l Gently, without force, apply pressure to the fingertip to collect a drop of blood. Step 6 l Wipe away the first drop of blood with gauze. l Try not to squeeze the finger too much as this may change test results. Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
COLLECTING THE BLOOD SAMPLE 10. Step 7 l Gently, without force, apply pressure to the fingertip to collect a second drop of blood. l Try not to squeeze the finger too much as this may change test results. Step 8 l Touch the blood sample tip to the drop of blood. The tip will fill with blood. l Once the blood goes into the tip of the Test Device, the blood will not come out. Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential. Go to next page now
9 11. RUNNING THE TEST Step 9 PUSH VERY HARD l Put Test Holder on Flat Surface or Table. l Hold the Test Device as shown in the picture. PUSH VERY HARD l The Test Device should meet the Test Holder as shown in the picture. l You do not need to hold the test device after pushing it down. Table Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential. Go to next page now
10 RUNNING THE TEST 12. Step 10 WRITE START TIME NOW. 15 Minutes You will see a pink/red color within 1 MINUTE to show you that the test is working. Read test results 15 MINUTES AFTER START TIME. READ RESULT TIME. 20 Minutes Do not read later than 20 MINUTES FROM START TIME. Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential. Go to next page now
11 13. TEST RESULTS (Use Scale on page 15 to compare your results) n To find out what a negative or positive result means to you, read the information booklet. NEGATIVE ONE Control Line and NO Result Line. Control Line can be ANY shade of light pink to dark pink/red. POSITIVE ONE Control Line and ONE Result Line. Result Line can be ANY shade of light pink (Example 1) to dark pink/red (Example 2). Example 1 Example 2 CONTROL LINE NO RESULT LINE CONTROL LINE RESULT LINE CONTROL LINE RESULT LINE Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential. If your test does not look like any of these pictures go to the next page.
(Use Scale on page 15 to compare your results) TEST RESULTS 14. If your test DOES NOT show a CONTROL LINE your result is INVALID. That means there was a PROBLEM with the test. INVALID RESULT NO pink/red Control Line. Example 1 Example 2 NO CONTROL LINE NO RESULT LINE NO CONTROL LINE WITH RESULT LINE The test is invalid and you should call the Support Center toll free number 1-800-000-0000.
15. Comparison Scale The pictures below show the possible results you can see with your test. Compare your results with the actual size images below to help you to be sure of your test results. NEGATIVE RESULT POSITIVE RESULT INVALID RESULT Support Center Toll Free Number: 1-800-000-0000 Available 24 hours a day, 7 days a week, and is completely private and confidential.
SURE CHECK AT HOME HIV TEST
Manufactured by: SURE CHECK HIV HOME TEST 3661 Horseblock Rd., Medford, NY 11763 USA Email: info@chembio.com Web Site: www.chembio.com