The NADAL® COVID-19 IgG/IgM Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-SARS-CoV-2 IgG and IgM in human whole blood, serum or plasma specimens of symptomatic patients.
Note that in the early stages of infection (3 to 7 days) anti-SARS-CoV-2 IgG and IgM may be below the detection limit of the test. This test is intended for use as an aid in the diagnosis of primary and possible secondary SARS- CoV-2 infections.
The test procedure is not automated and requires no special training or qualification. The NADAL® COVID-19 IgG/IgM Test is designed for professional use only
ABOUT THE COVID-19 (Coronavirus Disease)
COVID-19 (Corona Virus Disease) is the infectious disease caused by the recently discovered coronavirus SARS-CoV-2. This new virus was unknown before the disease outbreak in Wuhan, China, in December 2019. The most common symptoms of COVID-19 are fever, dry cough, fatigue, sputum production, shortness of breath, sore throat and headache. Some patients may have myalgia, chills, nausea, nasal congestion and diarrhoea. These symptoms begin gradually and are mild in most of the cases. Some people become infected but do not develop any symptoms and do not feel unwell. Most people (about 80%) recover from the disease without special treatment.
Approximately one in six people who get infected with COVID-19 becomes seriously ill and develops difficulty breathing. Elderly people, and those with pre-existing conditions, such as high blood pressure, heart problems or diabetes, are more likely to develop serious illness. So far, about 2% of infected people have died.
COVID-19 is transmitted via respiratory droplets that are exhaled by infected people via coughing, sneezing or talking. These droplets can be inhaled or ingested directly by other people or can contaminate surfaces, which can then be infectious for several days. Most estimates of the incubation period for COVID-19 range from 1 to 14 days, during which people might already be infectious without showing disease symptoms.
How to use the COVID-19 test
Wash the patient’s hand with soap and warm water or clean it with an alcohol pad. Allow it to dry.
Massage the hand, without touching the puncture site, by rubbing along the hand towards the fingertip of the middle of ring finger.
Puncture the skin with a sterile lancet. Wipe away the first drop of blood.
Gently rub the hand from the wrist to the palm, and then to the finger to form a rounded drop of blood over the puncture site.
Fingerstick whole blood should be tested immediately.
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) prior to testing.
Remove the test cassette from the foil pouch and use it as soon as possible. The best results will be obtained if the test is performed immediately after opening the foil pouch. Label the test cassette with the patient or control identification.
Place the test cassette on a clean and level surface.
Holding the pipette vertically, draw the specimen (whole blood/serum/ plasma) up to the first widening (approximately 10 μL) and add it to the to the specimen well (S) of the test cassette. Alternatively, a micropipette (10 µl) may be used.
Holding the buffer bottle vertically, add 2 drops (approximately 80 μL) of buffer to the buffer well (B). Avoid air bubbles forming.
Start the timer.
Wait for the coloured line(s) to appear. Read the test result after 10 minutes. Do not interpret the result after more than 20 minutes.
In addition to the control line ‘C’, a coloured line develops in the test line region ‘IgM’ and another in the test line region ‘IgG’. The result is indicative of a possible secondary SARS-CoV-2 infection.
Note: The colour intensity in the test line region ‘IgG’ and ‘IgM’ may vary depending on the concentration of anti-SARS- CoV-2 antibodies in the specimen. Therefore, any shade of colour in the test line region ‘IgG’ or ‘IgM’ should be considered positive. Note that this is a qualitative test only and it cannot determine the analyte concentration in the specimen.
Results from any test which has not produced a control line at the specified reading time must be discarded. Please review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your distributor.
Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control line failure.