USA production
Not for use in USA
To support in detection of IgM and IgG antibodies against the new SARS-CoV-2 virus.

The 2019-nCoV IgG/IgM test offers high accuracy and convenient usability as only a fingerstick blood
sample is needed.

Results in 10 minutes.

General information about IgG and IgM antibodies in the new coronavirus infection

Antibody testing may be helpful for the diagnosis of suspected COVID-19 patients with negative PCR results and for the identification of asymptomatic infections.

After symptom onset the median day when the patient became positive for IgG/IgM antibodies was 13 days.

Within the first 5-7 days the IgG antibodies are detectable in 50% of the patients.

A negative antibody test done within 2 weeks of the symptom onset is recommended to be repeated at a later time to ensure reliable result.
Ελληνικά
Take the sample from the side of the middle finger or the ring finger.
Use alcohol pad to clean the fingertip.
Place the lancet firmly
against the skin and
puncture the skin. Squeeze
and wipe off the first blood
drop.
To increase the
blood flow, squeeze
the finger firmly but not
continuously.
Hold the dropper
vertically and draw
blood up to 1 cm above the
fill line.
1
2
3
4
Remove the cassette
from the foil pouch and
place it on a clean and level
surface. Transfer 1 full drop
of blood (approximately 20
μl) to the sample well (S).
Add 2 drops of buffer
(approximately 80 μl)
and start the timer.
Read the results at
10 minutes.
Do not
interpret the results after 20
minutes.
5
6
7
Please consult
the instructions
for use before
performing
the test.
IgM Positive
IgG Positive
Negative
IgM Negative
IgG Positive
IgM Positive
IgG Negative
Invalid
Invalid
Invalid
Invalid
Evaluation of 9 commercial SARS-CoV-2 immunoassays
A box contains

25 x Individual Packed Cassette devices (Rapid Tests)
25 x Capillary tubes
1 x Detection Buffer (3 ml/Bottle)
1 x Instructions for Use
OnSite COVID-19 IgG/IgM Rapid Test
The OnSite COVID-19 IgG/IgM Rapid Test is designed for initial screening by detecting anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.

This test is easy-to-use, requires only minimally skilled personnel with basic equipment needs

The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% sensitivity and 97.8% specificity making it one of the most effective screening tests for COVID-19.
97.1% Sensitivity
97.8% Specificity