The kit consists of test card, sample buffer,swab and sample collector. Test card: It is composed of aluminum foil bag, desiccant, test strip and plastic card. Among them, the test strip is composed of absorbent paper, NC membrane, sample pad, binding pad and rubber sheet. The NC membrane T line (test line) is coated with 2019-nCoV Ab, the C line (quality control line) is coated with goat anti -mouse polyclonal Ab, and the binding pad contains a marker-labeled 2019-nCoV Ab. Sample buffer: Phosphate buffer, surfactant, etc.
The kit is used for qualitative detection of 2019-nCoV Ag collected from human saliva / sputum samples. It is for both home use and professional use.
As a new type, 2019-nCoV is a kind of β-CoVs. It can cause viral pneumonia, with main clinical manifestations of fever, fatigue and dry cough. A few patients are accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases often develop dyspnea and/or hypoxemia after a week, and those at serious condition rapidly progress to acute respiratory distress syndrome, septic shock, kidney failure and death.
This product adopts a lateral flow immunoassay method for the qualitative detection of 2019-nCoV Ag in saliva / sputum samples from suspected patients. In the acute phase of infection, antigens are usually detected in saliva/sputum samples. Positive result indicates the presence of viral antigens, but the clinical relevance of the patient's medical history and other diagnostic information is also necessary to determine the infection status. A positive result can not exclude bacterial infection or co-infection with other viruses.
The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.
ADVICE: Do not eat, smoke, chew gum or similar items within 30 minutes prior to specimen collection. If the specimen secretion is insufficient or there is food residue in the mouth, you can use adequate water gargle.
① Collection of saliva samples: Before collecting saliva, first relax the cheek, gently massage the cheek with your finger for 15-30 seconds, carefully spit into the sample collector, try to collect the liquid, no bubbles, and wipe the sample with a disposable sterile swab. (See Figure 1)
Note: False negative results may have if the saliva sample is not collected properly.
Figure 1 Methods for sample collection
② Sputum sample collection: Ask the patient to cough deeply, collect the coughed sputum in a sample collector, and wipe the sample with a disposable sterile swab.(see Figure 1)
③ Sample processing: The collected sample should be processed as soon as possible with the sample buffer provided by this kit (if it cannot be processed immediately, the sample should be stored in a dry, sterilized and strictly sealed container), stored for no more than 24h at 2℃～8℃, and kept for a long time at -70℃ (but avoid repeated freezing and thawing).
Read the instructions carefully before testing. Please return all reagents to room temperature before testing, and the test should be performed at room temperature.
1. Sample processing (see Figure 2)
① Insert the sampled swab into the sample buffer, and rotate it close to the inner wall about 10 times to dissolve the sample in the solution as much as possible.
② Squeeze the swab tip along the inner wall of tube to keep the liquid flow into the tube as much as possible, remove and discard the swab.
③ Cover the dripper.
Figure 2 Sample processing
2. Test procedure (see Figure 3)
Figure 3 Test procedure
① Take out the test card.
② Add 3 drops (about 80μL) of the processed sample extract to the loading well of test card, and then start the timer.
③ Read the results when the card is placed at room temperature for 15 minutes. The result is invalid after 20 minutes.
Interpretation of test card (see Figure 4):① Positive result: Both the quality control line (C line) and test line (T line) appears. ADVICE: There is currently a suspicion of a COVID-19 infection. Please contact a doctor / family doctor or the local health department immediately and have a PCR confirmatory test carried out. Please follow local guidelines for self-isolation.
② Negative result: Only the quality control line (C line) and no test line (T line) appears
ADVICE: Please continue to comply with all applicable rules regarding contact with others and protective measures. Even if the test is negative, there may be an infection. If you suspect, repeat the test after 1-2 days, as the coronavirus cannot be accurately detected in all phases of an infection.
③ Invalid result: Quality control line (C line) fails to appear, so the test should be taken again.
ADVICE: This was possibly caused by an incorrect test execution. Please repeat the test. If the test results remain invalid, contact a doctor or a COVID-19 test center.
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