The GLINE-2019-nCoV Ag test is a colloidal gold immunoassay (CGIA) for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swabs and nasals from individuals suspected of SARS-CoV-2 infection within the first seven days of symptom onset. The GLINE-2019-nCoV Ag test does not distinguish between SARS-CoV and SARS-CoV-2.
Positive results indicate the presence of viral antigens, but clinical relevance to the virus is required to determine infection status. patient history and other diagnostic information. Positive results do not rule out the possibility of bacterial infection or co-infection with other viruses. The agent detected may not be the exact cause of the disease.
Negative results do not rule out SARSCoV-2 infection and should not be the sole basis for treatment or patient management decisions, including on infection control. Negative results should take into account the patient's recent exposures, history, and clinical signs and symptoms consistent with COVID-19.

SUMMARY AND EXPLANATION OF THE TEST
I new coronaviruses belong to the genus ß. COVID19 is an acute respiratory infectious disease. People are generally susceptible to the infection.
Currently, patients infected with the new coronavirus are the main source of infection; even asymptomatic infected people can be an infectious source.
Based on the current epidemiological situation, the incubation period is 1 to 14 days, mostly 3 to 7 days, but during this period, the patient still remains infectious.
The main manifestations include fever, fatigue and dry cough. In some cases, nasal congestion, runny nose, sore throat, myalgia and diarrhea are found.

PRINCIPLE OF THE TEST
The GLINE-2019-nCoV Ag test uses colloidal gold immunoassay technology in a sandwich method to detect SARS-CoV-2 nucleocapsid protein.
When samples are added to the well, the sample will flow down the test strip by capillary action . If SARS-CoV-2 nucleocapsid protein is present in the sample at a concentration at or above the detection limit of the assay, the protein will combine with colloidal gold-labeled SARS-CoV-2 antibodies.
This immune complex will be captured by anti-SARS-CoV-2 antibodies immobilized in the detection region (T) and will form a purplish-red detection line, which means SARS-CoV-2 antigen positive.
The test card detection also includes a control region (C). Upon completion of a valid test, a purplish-red control line will appear whether or not SARS-CoV-2 antigen is present in the sample. If the control line does not appear, the test result is invalid and the sample must be retested with another card.

WARNINGS
For use only in vitro diagnostic.
This assay has only been licensed for the detection of SARS-CoV-2 proteins but not for other viruses or
pathogens.
All results must be interpreted in conjunction with other information clinics available to your physician.
Use immediately after opening the pouch containing the test device.
Avoid touching bleeding areas of the nasopharynx during specimen collection, as excess blood or mucus on the swab may interfere with the test and produce a false positive result.
Do not use if the test device packaging is damaged.
Do not use the contents of the kit beyond the expiration date.
Do not eat, drink or smoke in area where samples and kit contents are handled.
No n interchange kit contents of different lots.
No known diagnostic method can offer absolute certainty that patient-derived products do not transmit the virus. Therefore, all patient collected material should be considered potentially infectious.
Disposal of all waste material should comply with local guidelines.
Clean up and disinfect all specimen or reagent spills using an appropriate disinfectant .
Specific training or guidance is recommended if operators are inexperienced with specimen collection and handling procedures. Wear protective clothing such as lab coats, disposable gloves, and eye protection when specimens are collected and evaluated.

SPECIMEN COLLECTION AND HANDLING
Proper methods of specimen collection and preparation are essential. Samples obtained when the patient's viral load is high will contain the highest viral titers; samples obtained 7 days after symptoms are more likely to produce negative results than an RT-PCR test.
Improper collection, handling, or transport of specimens may produce false negative results; sample collection training is therefore highly recommended due to the importance of sample quality for generating accurate test results.

TEST PROCEDURE
Read the instructions for use carefully before testing.
Allow the test card, swab and sample to reach room temperature before testing.
Step 1:
Remove a Sample Extraction Tube and Test Card from the foil pouch immediately prior to testing.
Label a Test Card and Sample Extraction Tube for each sample or control to be tested .
Place the labeled extraction tubes in a rack in the designated area of the workspace.
Step 2:
Unscrew the bottle head and dispense all of the extraction reagent into the extraction tube of the sample.
Step 3:
After sample collection, insert the swab into the tube a sample extraction, dip and press the swab tip up and down in the fluid for at least 15 seconds, being careful not to splash the contents out of the tube.
Step 4:
Remove the swab by squeezing the sides of the tube to extract liquid from the swab.
Step 5:
Push the included dispensing tip onto the extraction tube containing the processed sample (not à threading or twisting is required).
Mix thoroughly by swirling or shaking the bottom of the tube.
After treating the swab in the extraction reagent, the sample must be analyzed within 30 minutes.
Step 6: Adding the sample to the test card.
Invert the extraction tube and hold it upright (about one inch above the sample well).
Gently squeeze the ridged body of the tube, dispensing three (3) drops of the processed sample into the sample well.
If there is sufficient processed sample left in the tube, it can be used to repeat the test if necessary.
Step 7:
When the test begins, a purple colored substance will move across the results window in the center of the test card.
The results should be read 15~20 minutes after adding the processed sample to the sample well. The results read after 30 minutes are invalid and have no clinical significance.

INTERPRETATION OF THE RESULTS
Positive (+)
Purple-red lines appear in the region of control (C) and in the detection region (T). This indicates that the nucleocap protein

Negative (-)
A colored band appears in the control area but not in the detection area. This indicates that the SARS-CoV-2 nucleocapsid protein is not present in the sample or that the viral load in the sample is below the limit of detection of the assay.

Invalid
No band colored appears in the control region after performing the test. The instructions may not have been followed correctly or the test may
be deteriorated. It is recommended to re-examine the sample.

FORMAT
The GLINE-2019-nCoV Ag kit contains:
Sealed sachet* (pcs): 20
Extraction reagent, 400 μl/tube (pcs): 20
Sample extraction tube, each with dispenser cap (pcs): 20
Sterile swabs (pcs): 20
Instructions for use (pcs ): 1