German Manual


Study Report

[STORAGE AND STABILITY]

• Store as packaged in the sealed pouch at temperature (4-30℃ or 40-86℉). The kit is stable within the expiration date printed on the labeling.
• Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.
• The LOT and the expiration date were printed on the labeling.

[SPECIMEN]

Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield false results; therefore, training in specimen collection is highly recommended due to the importance of specimen quality to obtain accurate test results.

Acceptable specimen type for testing is a direct nasal swab specimen obtained by the dual nares collection method.

Prepare the extraction tube according to the Test Procedure and use the sterile swab provided in the kit for specimen collection.

Nasal Swab Specimen Collection

1. Remove the swab from the package.
2. Tilt patient’s head back about 70°.
3. Mit vorsichtigem Drehen führen Sie den AnteriorNasenabstrich etwa 2,5 cm in das Nasenloch ein, bis bei der
   hinteren Nasenwand ein leichter Widerstand auftritt.
4. Drehen Sie den Anterior Nasenabstrich mehrmals gegen
   die hintere Nasenwand und wiederholen Sie den Vorgang in
   dem anderen Nasenloch mit demselben Nasenabstrich.

   [TEST PROCEDURE]

   Note: Allow the test cassettes, reagents and specimens to equilibrate to room temperature (15-30℃ or 59-86℉) prior to testing.

   1. Put an extraction tube on the work station.
   2. Unscrew the lid of an extraction reagent. Add all of the extraction reagent into the extraction tube.
   3. Sampling refers to section ‘Specimen Collection’.
   4. Insert the nasal swab specimen into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube. Leave the nasal swab in the extraction tube for one minute.
   5. Remove the nasal swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test sample.
   6. Cover the extraction tube with a dropper tip tightly.
   7. Remove the test cassette from the sealed pouch.
   8. Reverse the specimen extraction tube, holding the tube upright, transfer 3 drops (approximately 100 μL) slowly to the specimen well (S) of the test cassette, then start the timer.
   9. Wait for colored lines to appear. Interpret the test results at 15 minutes. Do not read results after 20 minutes.