will bind to coronavirus IgM antibodies if they are kits are valid for 18 months (see the kit

hs (see the kit box for

present, forming an IgM-IgM complex. The sample expiration information).
and antibodies will then move across the cassette’s
medium via capillary action. If coronavirus IgM • REQUIRED INSTRUMENTS
antibody is present in the sample, the test line (T) will
be bound by the IgM-IgM complex and develop color. None
If there is no coronavirus IgM antibody in the sample, • SAMPLE PREPARATION FOR TEST
free mIgM will not bind to the test line (T) and no
Novel Coronavirus (SARS-CoV-2) color will develop. The free chicken IgY antibody Assay is for use with human whole blood from a
will bind to the control line (C); this control line finger prick as indicated below:
IgM Antibody Detection Kit should be visible after the detection step as this a. Wash your hands with warm water
(Colloidal Gold) for Finger Prick confirms that the kit is working properly. b. Select the finger pad you are going to prick and
choose a puncture site off center of the fingertip
Samples Manual c. Massage and/or shake to stimulate blood flow
• KIT COMPONENTS towards the collection area
Catalog #: CG-CoV-IgM-FP d. Clean the collection area and the pipet provided
Component Specification Quantity Ingredients
in cartridge bag with an alcohol swab (provided
Detection 1 unit / bag 20 bags per Test cassette, in kit)
• PRODUCT NAME e. Place the finger with chosen collection site on a
Generic name: Novel Coronavirus (SARS-CoV-2) Cassette kit plastic pipette
flat surface facing up
IgM Antibody Detection Kit (Colloidal Gold Method) dropper, f. Twist the cap off the Lancet (provided in kit) and
for Finger Prick Samples. press firmly against the collection site to
desiccant
puncture the finger.
Sample Diluent 245 µl / tube 20 tubes Sample g. Create a large drop of blood by applying
• PRODUCT SPECIFICATIONS pressure at the base of the finger and massaging
20 tests/box per kit diluent, upward
liquid h. Squeeze the pipet bulb to expel air. Draw
• EXPECTED USAGE fingertip blood into the pipet by gently releasing
This kit is suitable for the qualitative detection of
Lancet 20 units / bag 20 lancets Lancet device the bulb. The pipet should be filled just up to the
novel coronavirus (SARS-CoV-2) IgM antibodies in per kit
indicated line (refer to the Figure 1 below). Take
human whole blood from a finger prick. Common care to avoid bubbles.
signs of a person infected with a coronavirus include Bandage 20 unit / box 20 units Bandage i. Expel the drawn up blood into the Sample
respiratory symptoms, fever, cough, shortness of Diluent vial and mix thoroughly by squeezing
per kit pipet 2-3 times. Use the pipet to add 2-3 drops to
breath, and dyspnea. In more severe cases, infection
can cause pneumonia, severe acute respiratory Alcohol pad 20 unit / box 20 units Alcohol pad the release pad section (S) of the Detection
syndrome (SARS), kidney failure, and even death. Cassette.
per kit
Coronavirus can be excreted through respiratory Fill to Here
secretions or transmitted through oral fluids, sneezing,
physical contact, and through air droplets. The components of the Detection Cassette are:
1. Novel coronavirus N protein (fixed on porous
capillary membrane) Figure 1: Representative pipette and amount of
• DETECTION PRINCIPLES 2. Goat anti-chicken IgY antibody (fixed on blood to draw up for test (indicated in gray).
The detection kit uses the principle of porous capillary membrane)
immunochromatography: the separation of 3. Colloidal gold-labeled mouse anti-human IgM
components in a mixture through a medium using • SAMPLE PRESERVATION
antibody (on the release pad) Samples should be run as soon as possible after
capillary force and the specific and rapid binding of 4. Colloidal gold-labeled chicken IgY antibody
an antibody to its antigen. Each cassette is a dry collection per the instructions above.
(on the release pad)
medium that has been coated separately with novel Note: The components in different batches cannot
coronavirus N protein (“T” test line) and goat anti- be used interchangeably. • TESTING METHOD
chicken IgY antibody (“C” control line) (Figure 2). Read the instructions carefully before use. Bring the
Two free colloidal gold-labeled antibodies, mouse Detection Cassette, Sample Diluent, and sample to
anti-human IgM (mIgM) and chicken IgY, are in the • STORAGE AND EXPIRATION
room temperature before testing.
release pad section (S). Once diluted whole blood is Keep kits in a cool and dry place at 2 – 30°C. Do not
applied to the release pad section, the mIgM antibody freeze the individual kits and/or box. Correctly stored

RayBiotech SARS-CoV-2 IgM Antibody Detection Kit Finger Prick Catalog #: CG-CoV-IgM-FP Current version number: V1.0
 a. Add 25µl of sample to the Sample Diluent
and mix thoroughly. Add 2-3 drops to the
release pad section (S) of the Detection
Cassette.
b. The results can be interpreted is 8-10 minutes.
Results measured after 20 minutes are invalid
and should be discarded.
INTERPRETATION OF TEST RESULTS
a. Positive for 2019-nCoV: Both the test line (T)
and the quality control line (C) are colored
dark pink.
b. Negative for 2019-nCoV: The test line (T)
does not develop color, or a faint gray band
may be visible, but the quality control line (C)
is colored.
c. Suspect: A light pink band is an inconclusive
result. The sample requires an alternate testing
method (such as RT-qPCR) to determine
positivity.
d. Invalid: There is no colored control line (C)
band. The results are invalid regardless of
whether a red band appears on the test line (T);
additional testing is required.
Figure 2: Representative schematic of possible
lateral flow device results.
Note: If the color saturation on the test line (T) is
darker than that shown for the “suspect” band, it
should be judged as a positive result.
• LIMITATION OF DETECTION METHOD
a. The product is designed only for use with
human whole blood finger prick samples for
the qualitative detection of novel coronavirus
(SARS-CoV-2).
b. This product test results are for reference only
and should not be the sole basis for diagnosis
and treatment. Use of this kit should be
combined with clinical symptoms and should
be confirmed by other conventional detection
methods.
c. Coronavirus may not be detected even though
coronavirus antibodies are present in the
RayBiotech SARS-CoV-2 IgM Antibody Detection Kit Finger Prick
sample, leading to a false negative. This may e. Do not use tap water, purified water or distilled
occur if the amount of coronavirus antibodies water as negative controls.
is below the detection level of the kit. To f. The test should be used within 1 hour after
decrease the chance of obtaining a false opening. If the ambient temperature is higher
negative, it is recommended that both CoV than 30 °C, or the test environment is humid,
IgG and IgM are tested (cat #CG-CoV-IgG-FP, the Detection Cassette should be used
# CG-CoV-IgM-FP). immediately.
d. If the product gets wet prior to use, or is stored g. If there is no movement of the liquid after 30
improperly, it may cause incorrect results. seconds of beginning the test, 1 additional drop
of sample solution should be added.
h. Take care to prevent the possibility of virus
• PRODUCT PERFORMANCE INDEX infection when collecting samples. Wear
a. Confirmation of Positive Reference samples disposable gloves, masks, etc., and wash your
per batch: 3 individual positive references hands afterwards.
samples were tested, and the result should i. This test card is designed for a single, one-time
identify all as positive samples. Results found use. After use, the test card and samples should
3 of 3 to be a positive and valid result. be regarded as medical waste with risk of
b. Confirmation of Negative Reference samples biological infection and properly disposed of
per batch: 20 negative reference samples and in accordance with national regulations.
products were tested, and the results should
find all samples as negative. Results found 20 Version: V1.0 Date: 2020 – MAR-18
of 20 samples to show a negative and valid
result. Product Code: CG-CoV-IgM-FP
c. Minimum detection limit: 3 samples at
different concentrations of antibodies were For ordering information or other inquires, contact us:
tested, whereby a correct dilution (L3) and a
lower dilution (L2) should be positive, while a
too far diluted sample (L1), should be
negative. Results confirmed L3, and L2 as
positive, while L1 was negative.
d. Repeatability: 10 Detection Cassettes for the
sample positive sample across 2 different lots
of Detection Cassettes were probed
simultaneously. All 10 showed a positive and
valid result.
• PRECAUTIONS
a. This product is for in vitro diagnostic use only,
following guidance from the FDA for
Emergency Use Authorizations of tests
submitted for approval on March 16, 2020.
This test has not been reviewed by the FDA
and results from antibody testing should not be
used as the sole basis to diagnose or exclude
SARS-CoV-2 infection or to inform infection
status.
b. The assay should be performed as outlined in
this manual, and in accordance with all
instructions.
c. Do not use expired or damaged products.
d. Only use the matching diluent in the kit
package. Diluents from different kit lots cannot
be mixed.
Catalog #: CG-CoV-IgM-FP Current version number: V1.0