Wondfo IgG IgM Antibody Self Rapid Test 1 Pack 20 Test (Lateral Flow Method) CE Certified

SKU Wondfo002
$499.99
In stock
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Product Details

Wondfo SARS-CoV-2 IgG IgM Antibody Coronavirus Rapid Test (Lateral Flow Method)

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MATERIAL Material Provided
1. 20 Individual sealed pouches, each pouch contains:
1 x Test cassette
1 x Desiccant pouch
2. 20 x disposable droppers
3. 1 x Detection buffer (1*6 mL) for 20 tests
4. 1 x Instructions for use

Material Required but Not Provided
1. Specimen Collection Containers
2. Centrifuge (for serum/plasma sample)
3. Timer
4. Personal protective equipment, such a protective gloves, medical mask, goggles and lab coat.
5. Appropriate biohazard waste container and disinfectants.



TEST PROCEDURE
Please read the instruction for use carefully before performing the
test.
1. Allow the device, buffer and specimen to equilibrate to room
temperature (10ºC 30ºC) prior to testing.
2. Remove a test cassette from the foil pouch by tearing at the notch
and place it on a level surface.
3. Transfer 10 L of whole blood or serum or plasma specimen to the
sample well (small well) and then add 2-3 drops (80 L) of buffer
solution to the buffer well (large well).
4. As the test begins to work, you will see purple color move across
the result window in the center of the test device.
5. Wait for 15 minutes and read the results. Do not read results after
20 minutes.



Certificate:





INTENDED USE
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is an
immunochromatographic assay for rapid, qualitative detection of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
IgG/IgM antibody in human whole blood, serum or plasma sample.
The test is to be used as an aid in the diagnosis of coronavirus
infection disease (COVID-19), which is caused by SARS-CoV-2.
The test provides preliminary test results. Negative results don?t
preclude SARS-CoV-2 infection and they cannot be used as the sole
basis for treatment or other management decision.
For in vitro diagnostic use only. For professional use only.



SUMMARY
On December 31, 2019, several cases of pneumonia in Wuhan City,
Hubei Province of China were reported to the World Health
Organization (WHO). The novel virus, now known as SARS-CoV-2
(previously known as 2019-nCoV), a RNA virus of the beta
coronavirus family, has since spread across China and to other
countries and territories. The WHO has named the disease caused by
SARS-CoV-2 as coronavirus disease 2019 (abbreviated
COVID-19.



PRINCIPLE
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is based
on the principle of capture immunoassay for determination of
SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum and
plasma. When the specimen is added into the test device, the
specimen is absorbed into the device by capillary action, mixes with
the SARS-CoV-2 antigen-dye conjugate and flows across the
pre-coated membrane.
When the SARS-CoV-2 antibodies level in the specimen is at or
above the target cutoff (the detection limit of the test), the antibodies
bound to the antigen-dye conjugate are captured by anti-human IgG
antibody and anti-human ? chain antibody immobilized in the Test
Region (T) of the device, and this produces a colored test band that
indicates a positive result. When the SARS-CoV-2 antibody level in
the specimen is zero or below the target cutoff, there is not a visible
colored band in the Test Region (T) of the device. This indicates a
negative result.
To serve as a procedure control, a colored line will appear at the
Control Region (C), if the test has been performed properly.



PRECAUTION
1. This kit is for in vitro diagnostic use only.
2. All specimens should be treated as capable of transmitting
diseases. Use appropriate precautions in the collection, handling,
storage and disposal of patient samples and used kit contents. And
follow biosafety level 2 or higher guidelines.
3. Wear appropriate personal protective equipment (e.g. gowns,
gloves, eye protection) when handing the contents of this kit.
4. Proper specimen collection storage and transport are critical to the
performance of this test.
5. Discard after first use. The test cannot be used more than once.
6. Do not touch the reaction area of test strip.
7. Do not use test kit beyond the expiration date.
8. Do not use the kit if the pouch is punctured or not well sealed.
9. Testing should be applied by professionally trained staff working in
certified laboratories or clinics at which the sample(s) is taken by
qualified medical personnel.
10. The test result should be interpreted by the physician along with
clinical findings and other laboratory test results.
11. DISPOSAL OF THE DIAGNOSTIC: All specimens and the
used-kit has the infectious risk. The process of disposing the
diagnostic must follow the local infectious disposal law or
laboratory regulation.



STORAGE AND STABILITY
1. Store at 2~30ºC in the sealed pouch up to the expiration date
printed on the package. Do not freeze.
2. The test cassette should be used within 1 hour after taking out from
the foil envelope. Buffer solution should be re-capped in time after
use.
3. Keep away from sunlight, moisture and heat.
4. Kit contents are stable until the expiration date printed on the outer
box.



SPECIMEN COLLECTION AND PREPARATION
The test can be performed with whole blood, serum and plasma.
For whole blood:
1. Using standard phlebotomy procedure, collect a venipuncture
whole blood specimen using a blood collection tube with suitable
anticoagulant (containing EDTA, Heparin or Citrated sodium).
Other anticoagulants have not been validated and may give
incorrect result.
2. It is recommended that whole blood specimen is tested at the time
of specimen collection. If the specimens are not tested
immediately, they may be stored at 2ºC 8ºC for up to 7 days.
Prior to testing, mix the blood by gentle inversion several times, do
not freeze or heat whole blood specimens.
For Serum and Plasma:
1. Using standard phlebotomy procedure, collect a venipuncture
whole blood specimen using a blood collection tube. If collecting
plasma use a blood collection tube containing suitable
anticoagulant (containing EDTA, Heparin or Citrated sodium).
Other anticoagulants have not been validated and may give
incorrect result.
2. Centrifuge whole blood and separate the plasma from red blood
cell as soon as possible to avoid hemolysis.
3. Test should be performed within 8 houres after the specimens have
been collected. Do not leave the specimens at room temperature
for prolonged periods. Serum or plasma specimens may be stored
at 2ºC?8ºC for up to 3 days prior to testing. Serum or plasma
specimens may be stored at -20ºC for up to 9 days.
Note: Bring specimens to room temperature before testing. Frozen specimens
must be completely thawed and mixed well prior to testing. Specimens should
not be frozen and thawed repeatedly. Severe hemolytic or heat-inactivated
specimens are not recommended.



RESULT INTERPRETATION
Positive Result
Colored bands appear at both test line (T) and control line (C). It
indicates a positive result for the SARS-CoV-2 antibodies in the
specimen.
Negative Result
Colored band appear at control line (C) only. It indicates that the
concentration of the SARS-CoV-2 antibodies is zero or below the
detection limit of the test.
Invalid Result
No visible colored band appear at control line after performing the
test. The directions may not have been followed correctly or the test
may have deteriorated. It is recommended that the specimen be
re-tested.



QUALITY CONTROL



A procedural control is included in the test. A colored line appearing in
the control region (C) is considered an internal procedural control. It
confirms sufficient specimen volume, adequate membrane wicking
and correct procedural technique.
Good laboratory practice recommends the use of the control
materials. Users should follow the appropriate federal state, and local
guidelines concerning the frequency of assaying external quality
control materials.



LIMITATIONS OF PROCEDURE
1. This reagent is designed to detect antibodies against SARS-CoV-2
in human whole blood, plasma, serum sample.
2. This reagent is a qualitative assay. It is not designed to determine
the quantitative concentration of SARS-CoV-2 antibodies.
3. The accuracy of the test depends on the sample collection process.
Improper sample collection, improper sample storage, or repeated
freezing and thawing of the sample will affect the test result.
4. The test result of this reagent are for clinical reference only, a
confirmed diagnosis should only be made after all clinical and
laboratory findings have been evaluated.
5. Limited by the method of antibody detection reagents, for negative
test results, it is recommended to use nucleic acid detection or
virus culture identification methods for review and confirmation.
6. Positive test results do not rule out co-infections with other
pathogens. A negative result of this reagent can be caused by:
1) Improper sample collection, improper sample transfer or
handing, the virus titer in the sample is too low;
2) The level of SARS-CoV-2 antibodies is below the detection limit
of the test.
3) Variations in viral genes may cause changes in antibody
determinants.

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