Saliva antigen rapid test kit DeepBlue

A rapid test for the qualitative detection of novel coronavirus antigens in human saliva.

For professional use only.

The saliva test is a convenient and safe method for assessing the risk of being infected with the novel coronavirus COVID-19. This helps you decide how to proceed regarding immediate treatment.

The test results can be interpreted quickly in 20 minutes.

Accuracy = 99.22%

Sensitivity = 97.1%

Specificity = 99.8%

Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients.

Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Important! Negative test results do not completely rule out being infected with SARS-CoV-2. If you continue to suspect any symptoms, further testing is strongly recommended. Call the family doctor hotline 1220.

Test principle:

This kit uses the double antibody-sandwich method to detect SARS-CoV-2 antigens. When an appropriate amount of specimen is added to the specimen well(s) of the test device, the specimen will move forward along the test device.  If the specimen contains an antigen, the antigen binds to mouse anti-SARS-CoV-2 N protein monoclonal antibody labeled with colloidal gold on the binding pad. Then, the immune complex forms a sandwich complex with another coated mouse anti- SARS-CoV-2 N protein monoclonal antibody on the test line. A visible colored line will show up, which indicates that the SARS-CoV-2 antigen is positive.

The test device also contains a quality control line, regardless of whether there is a test line, the red quality control line should appear. If the quality control line does not appear, it indicates that the test result is invalid and need to do the test again.

Specimen collection and preparation:

Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Collected specimens may be stored at 2-8℃ for no more than 24 hours. Store at -70 ℃ for a long time, but avoid repeated freeze-thaw cycles.

1. Before collecting oral fluid relax your cheeks and gently massage cheeks with fingers for 15-30s.
2. Gently spit oral fluid into collection container, try to collect oral fluid without bubbles.
3. Tear off the sealing film on the antigen extraction tube.
4. Use a dropper to draw the oral fluid and transfer 2-3 drops of oral fluid to the antigen extraction tube.
5. Insert a dropper tip into the extraction tube tightly.
6. Gently shake the extraction bottle for 10 seconds, to make sure the sample is well mixed.

Test procedure:

1. Read the instructions carefully before use and allow test device, extraction reagent and specimens to equilibrate to room temperature prior to testing.
2. Open the package and take out the test device.
3. Hold the extraction tube vertically and add two drops of the test specimens into the specimen well (s). Start the timer.
4. Interpret the results within 20 minutes. The results after 30 minutes are no longer valid.

Interpretation of test results:

1. Negative result: if there is only a quality control line C, the detection line T is colorless, indicating that SARS-CoV-2 antigen has not been detected and the result is negative.
2. Positive result: if both the quality control line C and the detection line T appear, indicating that SARS-CoV-2 antigen has been detected and the result is positive.
3. Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line T (as shown in the  figure below), and the test shall be conducted again.

Precautions:

1. Read the instructions carefully before using the kit, and strictly adhere to the reaction time. If you do not follow the instructions, you will get inaccurate results.
2. Do not eat, drink, chew gum, smoke or vape for at least 30 minutes before collecting saliva.
3. Guard against moisture, do not open the aluminum platinum bag before it is ready for testing. Do not use it if the aluminum foil bag is damaged or the test device is damp.
4. Please use it within the validity period.
5. Balance all reagents and specimens to room temperature (15 ~ 30 ℃) before use.
6. Do not replace the components in this kit with components from other kits.
7. Do not dilute the specimen when testing, otherwise you may get inaccurate results.
8. The kit shall be stored in strict accordance with the conditions specified in this manual. Please do not store the kit under freezing conditions.
9. The test methods and results must be interpreted in strict accordance with this specification.
10. Negative results may occur if the SARS-CoV-2 antigen titer in the specimen falls below the minimum detection limit of this kit.
11. If the extraction reagent is supplied individually (one piece per test device), the batch number, expiration date and other information cannot be marked separately due to limited space, but those details will be consistent with the corresponding test kit.
12. Both symptomatic and asymptomatic infections can be tested.

Store at 4℃~30℃, and it is valid for 24 months. After the aluminum foil bag is unsealed, the test device should be used as soon as possible and within one hour.