COVID-19 TEST KIT

NEWGENE COVID-19 Antigen Ag Self-Test – Sputum / Nasal – CE

This rapid corona test is suitable for the qualitative detection of the novel coronavirus in nasal and sputum swab samples. You can easily administer this test on your own by using a short nasal swab or by collecting deeply coughed sputum (saliva) in a paper cup. The sample is mixed with an extraction liquid and then placed on the test cassette, you will have the test result within 15-30 minutes. This product has the European CE mark for self-tests and is on the FAMHP list of authorized self-tests. If you want to be able to choose to test with a nasal swab or saliva, this test is the best alternative for you. The test has a sensitivity compared to the gold standard RT-PCR test of 97.3% and a specificity of 99.0%. Total accuracy is 98.1%.

SUMMARY
The new coronaviruses belong to the genus. COVID-19 is an acute infectious disease of the respiratory tract. Humans are generally susceptible. Currently, patients infected with the new coronavirus are the main source of infection; even asymptomatic virus carriers can be sources of infection. Based on current epidemiological research, the incubation period is 1 to 14 days, usually 3 to 7 days. The main symptoms are fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea also occur in some cases.

SPECIFICATIONS
This product is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the SARS-CoV-2 nucleocapsid protein. The test strip consists of the following parts: a sample pad, a reagent pad, a reaction membrane and an absorbent pad. The reagent buffer contains colloidal gold conjugated to the monoclonal antibody against the SARS-CoV-2 nucleocapsid protein; the reaction membrane contains secondary antibodies against the SARS-CoV-2 nucleocapsid protein. The whole strip is fixed in a plastic device. When the sample is added to the sample well, the conjugates absorbed in the reactive buffer are dissolved and migrate with the sample. If SARS-CoV-2 antigen is present in the sample, the anti-SARS-CoV-2 conjugate complex and the virus is captured by the specific anti-SARS-CoV-2 monoclonal antibodies coated on the test line (T). Absence of the T line indicates a negative result. To verify the procedure, a red line always appears in the control area (C), indicating that the correct volume of sample material has been added and that the membrane drainage effect has occurred.

COMPOSED

Cassette head
Sample extraction tube
drip cap
plastic cup
Sputumpipette

STORAGE AND STABILITY

Store the product packaging at a temperature of 2-30 ° C or 38-86 ° F and avoid exposure to sunlight. The kit is stable within the expiration date printed on the label.
Once the foil pouch is opened, the Test Cassette should be used within one hour. Prolonged exposure to a hot, humid environment can cause inaccurate results.
The lot number and expiration date are printed on the label.

WARNINGS AND PRECAUTIONS

Read the instruction manual carefully before using this product.
This product is for professional use ONLY.
This product is suitable for sputum samples. Using other types of specimens may cause inaccurate or invalid test results.
The sputum comes from the respiratory tract. This sampling method is recommended by the WHO.
Make sure the correct amount of test sample has been added. A sample that is too large or too small can cause inaccurate results
If the test line or control line is outside the test window, do not use the test cassette. The test result is invalid and retry the sample with a new test cassette.
This product is for single use only. DO NOT recycle used parts.
Dispose of used products, samples and other consumables as medical waste in accordance with applicable regulations.

MONSTERAFNAME

Ask the patient to take a deep breath and spit the deeply expelled sputum into the paper cup or sputum container. Note: If the patient ate or drank just before the collection, rinse the mouth with clean water.
Use the pipette to transfer 0.6 ml of the sputum sample into the extraction tube. The pipette takes 0.3 ml of sample at a time. Perform the sample transfer procedure 2 times. Note: the sputum is highly viscous. Strictly follow the instructions as described. Adding too much or too little of sample material can produce unreliable test results.
Detach the aluminum gasket from the extraction tube.
Put 0.6 ml of the sputum sample into the extraction tube. Note: the sputum is highly viscous. Strictly follow the instructions as described. Adding too much or too little of sample material can produce unreliable test results.
Use the pipette to mix the sputum sample with the 5x extraction fluid.
Press the drip cap firmly into the extraction tube. Wait at least 1 minute for the viral antigens to dissolve.

TEST PROCEDURES

Return test equipment and specimens to room temperature (15-30 ° C or 59-86 ° F) prior to testing.

Tap the bottom of the tube to mix the sample solution
Take a test cassette from the foil pouch and place it on a table. Hold the tube vertically and place 3 drops of the sample solution in the sample well (S) of the test cassette.
Read the result after 15-30 minutes. After 30 minutes, the result is considered inaccurate and invalid. Note: DO NOT re-insert the sample solution into the sample well of a used Test Cassette.

INTERPRETATION OF RESULTS

Positive (+): Red lines appear on both T and C lines within 15-30 minutes.

Negative (-): A red line appears on the C and no red line appears on the T line in 15-30 minutes after the sample is placed.

Invalid: Until a red line appears on the C, this indicates that the test result is invalid. The sample must be retested with a different Test Cassette.

PRODUCT PERFORMANCE

Limit of Detection (LoD): The LoD of this product is approximately 0.05 ng / mL SARS-CoV-2 nucleocapsid protein solution.

Sensitivity, specificity and total precision

Product performance was evaluated with clinical samples using commercial RT-PCR kits as a gold standard.

Sensitivity, specificity and total accuracy

Product performance was evaluated with clinical specimen using commercial RT-PCR kits as gold standard .

 

Sputum		RT-PCR		Total
		Positive	Negative
COVID-19-NG08	Positive	109	1	110
	Negative	3	96	99
Total		112	97	209
		Sensitivity	Specificity	Total Accuracy
		97.3% [92.4% -99.4%]	99.0% [94.4% -100.0%]	98.1% [95.2% -99.5%]

LIMITS

1. This product is only intended for assisted diagnosis of viral infections. A definitive clinical diagnosis should also consider factors such as symptoms and results of other tests.
2. A negative result indicates that the viral load in the tested sample is below the detection limit of this product. It cannot completely rule out the possibility of a viral infection from the patient.
3. A positive result indicates that the tested sample has a viral load above the limit of detection for this product. However, the color intensity of the test line may not match the severity of the infection or the patient’s disease progression.

For more information: [email protected]