MDConnect Healthcare

Prepare Materials

1. You may have Test Set 1 OR Test Set 2 in the package. Please follow proper steps based on the specific set you received.

2. Test Set 1: Open the package, take out the COVID-19 Test Card in Pouch, the Tube filled with the extraction buffer and the Swab. When you are ready to proceed with the test, open the foil pouch of the COVID-19 Test Card.

3. Please go directly to Step 2 Collect Sample

4. Test Set 2: Open the package, take out the COVID-19 Test Card in Pouch, empty Tube, sealed Solution and the Swab. When you are ready to proceed with the test, open the foil pouch of the COVID-19 Test Card.

5. Please look carefully, there are two Edges on the empty tub. Then squeeze the sealed solution completely into the empty tube.

6. Please confirm the liquid level with or above Edge 2, then go to Step 2 Collect Sample.

   Note: It is acceptable if the liquid level is above Edge 2. However, please do not proceed with this test if the liquid level is below Edge 2, as this may result in false or invalid results.

Collect Sample

1. Remove the swab from its package, being careful not to touch the tip of the swab. Please keep the swab package for later use.

2. Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril.

   Note: With children, the maximum depth of insertion into the nostril may be less than 3/4 of an inch, and you may need to have a second person to hold the child's head while swabbing.

3. Firmly and slowly brush against insides of nostril in a circular motion against the nasal wall at least 5 times. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab. Using the same swab, repeat the same sample collection procedure for the other nostril. Be sure to brush BOTH nostrils with the SAME SWAB.

   Note: Failure to swab properly may cause false negative results.

Process Sample

1. Tap the tube vertically on the table and twist the large orange cap to open the tube.

2. Insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at least 15 times.

3. Squeeze the sides of the tube to express as much liquid as possible from the swab, and then remove the swab.

   Note: If you don't squeeze the swab, there may not be sufficient sample material to perform the test properly (i.e., potentially resulting in a false negative result).

4. Screw back the large orange cap, put the swab back into the package. Safely dispose of the swab and the package.

Add Sample

1. Twist to open the small white cap of the tube. Add 3 drops of sample to the Sample Port of the COVID-19 Test Card. Screw back the small white cap.

   Note: A false negative or invalid result may occur if too little solution is added to the test card.

Wait 15 Minutes

1. Start the timer by clicking the “Start Timer” button, immediately after adding sample to the Sample Port. The result will be ready in 15 minutes.

   Note: Do NOT interpret your test result until after your 15-min timer has completed, as the T line may take as long as 15 minutes to appear.

Read Result

1. Results should not be read after 30 minutes (Result shown at 2x magnification).

   NOTE: A false negative or false positive result may occurif the test result is read before 15 minutes or after 30 minutes.

   NOTE: The T line can be extremely faint.

Test Result Explanation

1. A POSITIVE result must show BOTH a C line and a T line. A positive result means that viral antigens from COVID-19 were detected and the individual is positive for COVID-19.

2. A POSITIVE result must show BOTH a C line and a T line. A positive result means that viral antigens from COVID-19 were detected and the individual is positive for COVID-19.

   Below are photos of actual positive tests. Please note that the T line may be faint.

3. Persons who test positive should self-isolate and seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary.

4. A NEGATIVE result will show ONLY a C line. A negative result means that viral antigens from COVID-19 were not detected and that the individual is presumed negative for COVID-19.

5. • Please note that negative results do not rule out COVID-19.

   • In case of negative test result: Continue to follow all social distancing recommendations and take protective measures. If suspicions of infection persist and/or your first test is negative, repeat the test after 1-2 days and consult your healthcare provider or local COVID-19 center.

   • Note: A negative result is presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Individuals without symptoms that test negative should be tested again with at least 24 hours and no more than 48 hours between tests. Additional confirmatory testing with a molecular test for negative results may be necessary after second negative result for asymptomatic patients, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with as 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 SARS-CoV-2 or residing in communities with low prevalence of infection.

6. If there is NO LINE, or if there is ONLY a T line, the test is INVALID. Invalid result means that the test did not function correctly. You will need to retest with a new test kit. If upon retesting, the test result is still invalid, contact your doctor or local COVID-19 center. An invalid result does not indicate if the individual did or did not have COVID-19 and should be repeated.

Dispose the Test Kit

1. After test is completed, dispose the kit components in trash.

Report Test Result

1. Report the result following the App instructions or share your test result with your healthcare provider.

2. In the U.S.A. (1) This test is intended to be used as an aid to the clinical diagnosis of a current COVID-19 infection, Do not use this test as the only guide to manage your illness. (2) In USA - This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other virus 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)(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.