COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma),
membranebased immunoassay
A rapid test for the qualitative detection of IgG and IgM
antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimens.
For professional in vitro diagnostic use only.
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P |
| Certificate | CE |
| Reading Time | 10 minutes |
| Pack | 25T/40T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
INTENDED USE
The COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic
immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in
human whole blood, serum or plasma specimen from patients suspected of COVID-19 infection by a
healthcare provider. The COVID-19 IgG/IgM Rapid Test is an aid in the diagnosis of patients
with suspected SARS-CoV-2
infection in conjunction with clinical presentation and the results
of other laboratory tests. Results from the COVID-19 IgG/IgM Rapid Test should not be used as the sole
basis for diagnosis.
Results are for the detection of SARS-CoV-2 antibodies. IgM
antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection,
although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2
become detectable later following infection.
Negative results do not preclude SARS-CoV-2 infection and should
not be used as the sole basis for patient management decisions. IgM antibodies may not be
detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Rapid Test early
after infection is unknown.
False positive results for IgM and IgG antibodies may occur due to
cross-reactivity from pre-existing antibodies or other possible causes.
SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute
respiratory infectious disease. People are generally susceptible. Currently, the patients
infected by the novel coronavirus are the main source of infection; asymptomatic infected
people can also be an infectious source. Based on the current epidemiological
investigation, the incubation period is 1 to
14 days, mostly 3 to 7 days. The main manifestations include fever,
fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found
in a few cases.
PRINCIPLE
The COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) is a
qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to
SARS-CoV-2 in whole blood, serum or plasma specimen. This test consists of two components, an
IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG
test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the
test. The mixture then migrates upward on the membrane chromatographically by capillary
action and reacts with the anti-human IgG in IgG test line region, if the specimen contains
IgG antibodies to SARS-CoV-2. A colored line will appear in IgG test line region as a result of
this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM
antibodies to SARS-CoV-2, the conjugate-specimen complex reacts with anti-human IgM. A colored
line appears in IgM test line region as a result.
Therefore, if the specimen contains SARS-CoV-2 IgG antibodies, a
colored line will appear in IgG test line region. If the specimen contains SARS-CoV-2 IgM
antibodies, a colored line will appear in IgM test line region. If the specimen does not contain SARS-CoV-2
antibodies, no colored line will appear in either of the test line regions, indicating a negative
result. To serve as a procedural control, a colored line will always appear in the control line
region, indicating that the proper volume of specimen has been added and membrane wicking has
occurred.
REAGENTS
The test contains anti-human IgM and anti-human IgG as the capture
reagent, SARS-CoV-2 antigen as the detection reagent. A goat anti-mouse IgG is employed
in the control line system.
PRECAUTIONS
1. This package insert must be read completely before performing
the test. Failure to follow directions in insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after
expiration date.
3. Do not eat, drink or smoke in the area where the specimens or
kits are handled.
4. Do not use test if package is damaged.
5. Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards throughout all procedures and
follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
7. Please ensure that an appropriate amount of samples are used for
testing. Too much or too little sample size may lead to deviation of results.
8. The used test should be discarded according to local
regulations.
9. Humidity and temperature can adversely affect results.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at room temperature or
refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The
test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration
date.
SPECIMEN COLLECTION AND PREPARATION
The COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) can be
performed using whole blood (from venipuncture or fingerstick), serum or plasma.
To collect Fingerstick Whole Blood Specimens:
Wash the patient’s hand with soap and warm water or clean with an
alcohol pad. Allow to dry.
Massage the hand without touching the puncture site by rubbing down
the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded
drop of blood over the puncture site.
Add the Fingerstick Whole Blood specimen to the test by using a
capillary tube:Touch the end of the capillary tube to the blood until filled to
approximately 20uL. Avoid air bubbles.
Separate serum or plasma from blood as soon as possible to avoid
hemolysis. Use only clear non-hemolyzed specimens.
Testing should be performed immediately after the specimens have
been collected. Do not leave the specimens at room temperature for prolonged periods.
Serum and plasma specimens may be stored at 2-8°C for up to 7 days, for long term storage,
serum/plasma specimens should be kept below -20°C. Whole blood collected by venipuncture
should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze
whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen
specimens must be completely thawed and mixed well prior to testing. Specimens should not be
frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance
with local regulations covering the transportation of etiological agents.
EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can
be used as the anticoagulant for collecting the specimen.
DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it within
one hour. Best results will be obtained if the test is performed
immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Transfer 10 uL of specimen to the specimen well(S) with a pipette
or a dropper, then add 2
drops of buffer (approximately 80 uL) to Buffer well (B), and start
the timer.
For Venipuncture or Fingerstick Whole Blood specimen:
Transfer 20uL of specimen to the specimen well(S) with a pipette or
a dropper, then add 2 drops of buffer (approximately 80 uL) to
Buffer well (B), and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10
minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after
opening the vial.
INTERPRETATION OF RESULTS
IgG POSITIVE:* Two colored lines appear. One colored line should
always appear in the control line region (C) and another line should be in the G line region.
IgM POSITIVE:* Two colored lines appear. One colored line should
always appear in the control line region (C) and another line should be in the M line region.
IgG and IgM POSITIVE:* Three colored lines appear. One colored line
should always appear in the control line region (C) and two test lines should be in the G
line region and M line region.
*NOTE: The intensity of the color in the test line regions (G/M)
may vary depending on the concentration of SARS-CoV-2
antibodies present in the specimen. Therefore, any shade of color in the test line region (G/M) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C).
No line appears in the G region and IgM region.
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for control line failure.
Review the procedure and repeat the test with a new test. If the problem persists, discontinue
using the test kit immediately and contact your local distributor
