INTENDED USE
Monkeypox Virus Antigen Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay for the qualitative detection of monkeypox virus antigen in human serum, plasma or whole blood samples or rash exudate. It is intended to be used as a screening test and provides a preliminary test result for early diagnosis and management of patients related to infection with Monkeypox.
Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be combined to confirm the test result obtained by this device.
Summary and explanation
Monkeypox is a viral zoonotic disease with symptoms in humans similar to those seen in the past in smallpox patients. Monkeypox occurs in monkeys in the rain forests of central and western Africa, and can also infect other animals and occasionally humans. The clinical manifestations are similar to those of smallpox, but the disease is milder. The virus can be transmitted from animals to humans through direct close contact, and it can also spread from person to person. The main routes of infection include blood and body fluids. However, monkeypox is far less contagious than the smallpox virus.
Monkeypox Virus Antigen Detection Kit (Colloidal Gold) is an immunological diagnostic test used for detection of monkeypox virus Antigen based on the colloidal gold-immunochromatography assay. This method is rapid and convenient to use and requires few equipment. It can be performed within 15-20 minutes by minimally skilled personnel.
Materials Provided
Test Procedure
Step 1: Allow the test device, buffer, specimen to equilibrate to room temperature (15-30℃) prior to testing.
Step 2: Remove the test device from the sealed pouch. Place the test device on a clean, flat surface.
Step 3: Label the device with specimen number.
①For Plasma/Serum/Whole Blood:
Step 4: Using a Disposable Dropper, transfer serum, plasma or whole blood. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, and immediately add 2 drops of test buffer (approximately 70-100μl). Make sure there are no air bubbles.
Step 5: Set up a timer. Read the results in 15 minutes.
Do not interpret the result after 20 minutes. To avoid confusion, discard the test device after interpreting the result. If you need to store it for a long time, please take a photo of the result.
②For Rash Exudate:
Step 4: Wipe the rash exudate with a sterile swab;
Step 5: lnsert the swab into the extraction tube with buffer;
Step 6: Roll the swab at least 3 times while pressing the head against the bottom and side of the extraction tube.
Step 7: Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
Step 8: Drop 60-100ul sample (2-3 drops) into the test card.
Step 9: Set up a timer. Read the results in 15 minutes.
Do not interpret the result after 20 minutes. To avoid confusion, discard the test device after interpreting the result. If you need to store it for a long time, please take a photo of the result.
RESULTS
NEGATIVE:
If only the quality control line C appears, and the test lines T is not purple/red, it indicates that no antigen is detected, and the result is negative.
POSITIVE:
If both the quality control line C and the test line T appear purple/red, it indicates that the antigen is detected, and the result is positive.
INVALID:
If the quality control line C is not displayed, the test result is invalid regardless of whether there is a purple/red test line, and it should be tested again.
