Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2

(Colloidal Gold Immunochromatography)

 CONTENT

1 Introduction-COVID-19

2 Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2

3 SARS-CoV-2 IgM+IgG Antibody Detection

 COVID-19

Pathogen：SARS-CoV-2
Severe Acute Respiratory Syndrome Coronavirus 2

The strain of coronavirus became officially known as the severe

acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and also
referred to as 2019-nCoV. The infection caused by this virus is
known as coronavirus disease-2019 (COVID-19) . 2019-nCoV is a
beta-coronavirus, as are the viruses that cause severe acute
respiratory syndrome (SARS) and Middle East respiratory syndrome
(MERS) . These viruses are zoonotic (i.e. transmitted between
animals and humans) and have their origins in bats. Most people
become infected with these viruses at some point in their lives, and
usually the duration of illness is short. However, a comprehensive
clinical picture of COVID-19 is still not entirely clear .
 Comprehensive Screening and Monitoring of COVID-19

p IgM： Appear on day 1-7 of an acute

infection. Detection of IgM in blood
indicates a recent infection. It can be
used as early screening for Novel
CoV suspected population.
p IgG： In the mid to late stage of
infection B lymphocytes enter lymph
node and transform into plasma cells
and produce large amount of IgG.
Detection of IgG indicate on-going SARS-CoV-2 IgM+IgG Antibody Detection

or past infection, useful in the

monitoring of progress of infection.
Product Specification

Testing Colloidal Gold

Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2 Principle Immunochromatography
(Colloidal Gold Immunochromatography) Testing
10min
Time
Whole Blood, Serum,
Specimen
Plasma, Capillary Blood
Whole Blood(Capillary
Specimen
Blood) 20 μL;
Test Disposable Quantity
Diluent Serum(Plasma) 10 μL
cassette micropipette
Package 20 Tests / Box
Storage 2-30℃
Warranty
12 months
Hemostix dry cotton alcohol swab Period
User’s Manual ball
Advantage of Product
Suitable Population

High Risk Suspected Confirmed Susceptible

Obvious clinical Family members of Continue monitoring Elderly, children or

symptoms but confirmed or of disease progress immuno-suppressive
nucleoic test and monitoring of persons.
suspected patients.
negative patient. convalescent.
Recent close contact
person.
 Blood collection method

Whole Blood(Capillary
Fingertip blood Blood) 20 μL

Load 2-3 drops of the Wait for 10-20mins, and then read
diluent to the sample hole results

Whole Blood(Capillary Blood)

Venous blood 20 μL or Serum(Plasma) 10 μL
Preparation -Constant temperature

Open the carton, pick out the inner package, leave at room temperature, wait for 30mins.
Sample collection

1.Massage 2.Disinfect
Massage pulp of the left ring finger Wipe the needle puncture site with alcohol swab

5.Sample
5.采样collection
Suck一次性微量吸管吸血至20μL刻度
blood to the tick mark of the
线处，然后用无菌干棉球（棉签）
disposable micropipette, and then
press压住伤口止血；如血流不畅，可
wound with the aseptic dry
用左手从采血部位远端向指端稍
cotton ball to stop bleeding; If the
挤压使血流出。
blood flows is not enough, press the
3.Puncture 4.Wipe off left ring finger (from the palm
Hold the disposable sterile blood coll- After the blood flows naturally, wipe off the first towards the fingertip) slightly to
ection needle to puncture a depth of drop with an aseptic dry cotton ball. make blood flow out.
2-3mm on the ventral ulnar side of
fingertip by right hand, and then pull
out the needle immediately.
Testing process

1.Load sample 2.Dilute

A total of 20μL whole blood was loaded to Load 2-3 drops of the diluent to the sample hole of
the sample hole of the detection cassette. the detection cassette, and start the timer.

3.Read
Leave the detection cassette at room temperature for 10-20mins,
and then read results which will be invalid 20mins later.
Interpretation of Result

C C C C C C C C
G G G G G G G G
M M M M M M M M

Both IgG (+)

IgG (+) IgM (+)
& IgM (+)
Positive Result Negative Result Invalid Result