2019nCov Ag Combo Rapid Test Kit
Principio:
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) is a qualitative
membrane-based immunoassay for the detection of antibodies against
SARS-CoV-2 antigens in whole blood, serum or plasma. This test can
aid in determining whether or not a subject has been exposed to the
novel SARS-CoV-2 coronavirus, which causes the disease COVID-19.
When the mixed sample and buffer solution is added to the sample
well, the solution migrates up the test membrane by the capillary
effect. If there are anti-SARS-CoV-2 antibodies in the sample,
these bind SARS-CoV-2 antigens conjugated to colloidal gold, which
are present on the membrane; these migrate together up the membrane
to the test line regions. Mouse monoclonal anti-human IgG
antibodies are coated on the IgG test line, and these capture any
IgG antibodies in the sample, so that capture antibody-sample IgG
antibody-antigen-colloidal gold complexes accumulate at the IgG
line. Similarly, mouse monoclonal anti-human IgM antibodies coated
on the IgM test line can capture any IgM antibodies present in the
sample, so that capture antibody-sample IgM
antibody-antigen-colloidal gold complexes accumulate at the IgM
line. The accumulation of colloidal gold produces a visible line,
indicating a positive result for IgG and/or IgM. If the specimen
does not contain antibodies to COVID-19, no colored line will
appear in either of the test line regions, indicating a negative
result. The test results should be read after 10 minutes.
To serve as a procedural control, a colored line will always appear
in the control line (C) region, indicating that the proper volume
of specimen has been added and membrane wicking has occurred. If
the control line is absent, the result is invalid, and should be
repeated with a new sample and new cassette.
MATERIALS AND COMPONENTS
Materials provided with the test
Ingredients | Cassette | Instructions for use | Quick Reference Instructions |
|
Specifications |
0674C4X001 | 1 | 1 | NA |
0674C4X002 | 2 | 1 | NA |
0674C4X005 | 3 | 1 | 1 |
0674C4X010 | 10 | 1 | 1 |
0674C4X020 | 20 | 1 | 1 |
0674C4X025 | 25 | 1 | 1 |
Materials required but not provided
STORAGE AND STABILITY
- Store the test as packaged between 2-30°C.
- The Test stable until the expiration date printed on the outer
packing, the product will be expired after 24 months.
- Do not use beyond the expiration date.
- Do not freeze any contents of the test
- The test must remain in the sealed pouch until use.
TEST PROCEDURE
Before test, please read the instructions carefully.
- Take the cassette to equilibrate to room temperature.
- Unpack the aluminum foil bag, take out the cassette.
- Insert the absorber end of the cassette into mouth. Make sure
cassette is horizontal statement.
![](http://img.everychina.com/nimg/58/04/daa119aaabd5b4e6139ba7bf0adc.jpg)
- Actively swab the inside of the mouth and tongue to collect oral
fluid.
- Remove the absorber end from the mouth when the purple color move
across the result window in the center of the test device.
- Wait for 10 minutes and read the results.
NOTE:
*When sampling, gently hold it in mouth and let saliva naturally adsorb on the sponge.
*Do not eat, drink, or smoke prior to the test for at least 30 Minutes.
*Any saliva specimen is appropriate for testing but the saliva
specimen collected in the morning, before mouth rinsed, eating or
drinking, is recommended
INTERPRETATION OF TEST RESULTS
This product can only perform qualitative analysis on the detection
object.
Positive Result:
If both C and T lines are visible within 10 minutes, the test
result is positive and valid.
Negative Result:
If test area (T line) has no color and the control area displays a
colored line, the result is negative and valid
Invalid Result:
The test result is invalid if a colored line does not form in the
control region. The sample must be re-tested, using a
new test.
![](http://img.everychina.com/nimg/cb/d8/1ff8efde408c8dc5cfe0f67d5247.jpg)
INTERNAL CONTROL
The test contains a built-in internal control in the test card. A
color band appearing in the control region (C) is designed as an
internal control. The appearance of the control line confirms that
sufficient flow has occurred, and that the test card is working
normally. If the control line does not appear within 10 minutes, it
is considered an error in the test result and it is recommended to
test again with the same sample and a new device.
LIMITATIONS
- The result of the test should not be taken as a confirmed
diagnosis, for clinical reference only. Judgement should be made
along with RT-PCR results, clinical symptoms, epidemiological
information, and further clinical data.
- The Test performance depends on the amount of virus (antigen) in
the sample and may or may not correlate with viral culture results
performed on the same sample.
- The test must be equilibrated to room temperature (18℃~26℃) before
used, otherwise the results may be incorrect
- A negative test result may occur if the level of antigen in a
sample is below the detection limit of the test.
- Failure to follow the Test Procedure may adversely affect test
performance and/or invalidate the test result.
- React less than 10 minutes may lead a false negative result; React
more than 10 minutes may lead a false positive result.
- Positive test results do not rule out co-infections with other
pathogens.
- Negative test results are not intended to rule in other viral or
bacterial infections.
- Negative results should be treated as presumptive and confirmed
with a molecular assay.
- Clinical performance was evaluated with fresh samples.
- Users should test specimens as quickly as possible after specimen
collection.
PERFORMANCE CHARACTERISTIC
1. Clinical Verification
The performance of Test was established with 232 sample collected
from symptomatic patients, who with symptoms onset within 7 days.
2019-nCoV Saliva Ag EASY TEST | Comparative RT-PCR Test Result |
(Immunochromatography) |
| Positive (+) | Negative (-) | Total |
Detected Positive | 108 | 1 | 109 |
Detected Negative | 7 | 116 | 123 |
Total | 115 | 117 | 232 |
Sensitivity | 93.91%, 95% CI (87.97,97.02) |
Specificity | 99.15%, 95% CI (95.32, 99.85) |
Accuracy | 96.55%, 95% CI (93.34, 98.24) |
Positive results broken down by CT value:
2019-nCoV Saliva Ag EASY TEST | Comparative RT-PCR Method |
(Immunochromatography) | (Positive by Ct Value) |
| Positive (Ct<=25) | Positive (25<Ct) |
Detected Positive | 69 | 39 |
Total | 70 | 45 |
Positive agreement | 98.57% | 86.67% |
2. Limit of Detection
The experimental results show that for the virus culture
concentration above 100 TCID50/mL, the positive rate of detection
is greater than or equal to 95%. For the virus culture
concentration of 50 TCID50/mL and below, the positive rate of
detection is lower than 95%. So, the limit of detection of the Test
Card is 100 TCID50/mL.
3. Cross-reactivity
Cross-reactivity of the test card was evaluated. The results showed
no cross reactivity with the following specimen.
5. Precision
1. Test 10 replicates of negative and positive by using the
reference materials of enterprises. The negative agreement and the
positive agreement were 100%.
2. Test three different lots kits including positive and negative
reference materials of enterprises. The negative results and the
positive results were 100%
6. Hook Effect
The Test Card was tested up to 1.6 × 105 TCID50/ml of
heat-inactivated 2019-nCoV strain and no high-dose effect was
observed.
PRECAUTIONS
- For in vitro diagnostic use.
- Use appropriate precautions in the collection, handling, storage,
and disposal of patient samples and used test contents.
- Use of Nitrile, Latex (or equivalent) gloves is recommended when
handling patient samples.
- Do not reuse the used Test Card or saliva swab.
- Should never open the foil pouch of the Test Card exposing it to
the ambient environment until the Test Card is ready for immediate
use.
- Discard and do not use any damaged or dropped Test Card or
material.
- Inadequate or inappropriate sample collection, storage, and
transport may yield false test results.
- Sample collection and handling procedures require specific training
and guidance.
- To obtain accurate results, do not use visually bloody or overly
viscous samples.
- To obtain accurate results, an opened and exposed Test Card should
not be used.
- Testing should be performed in an area with adequate ventilation.
- Wear suitable protective clothing, gloves, and eye/face protection
when handling the contents of this test.
- Wash hands thoroughly after handling.
KEY TO SYMBOLS USED
![](http://img.everychina.com/nimg/c0/ed/57097637455fcdc0f782ae9da261.jpg) | Materials Included | | ![](http://img.everychina.com/nimg/8c/23/3ac09aa913369b2b1f86c4d2cbdb.jpg) | Test Cassette |
![](file:///C:UsersLIUHUI~1AppDataLocalTempksohtmlclip_image4.png) ![](http://img.everychina.com/nimg/8f/6d/0023dbbea60c6ed08bd433d12213.jpg) | Instructions for Use | | ![](http://img.everychina.com/nimg/09/a5/5b79a5f3b0b16519e802bf7ecfee.jpg) | Date of |
Manufacturer |
![](http://img.everychina.com/nimg/6e/c2/d8d3e7e70f738b5af44c3373e1bf.jpg) | Consult Instructions | | ![](http://img.everychina.com/nimg/41/1e/89be4ea00ca0fa142a45348b34e4.jpg) | Do Not Reuse |
For Use |
![](http://img.everychina.com/nimg/d2/c9/564c94e90252ad1b198c06065ad4.jpg) | Store at 2°C~30°C | | ![](file:///C:UsersLIUHUI~1AppDataLocalTempksohtmlclip_image9.png) ![](http://img.everychina.com/nimg/d7/af/18c12b34915ee7d58dea819e8a47.jpg) | Catalogue Number |
![](file:///C:UsersLIUHUI~1AppDataLocalTempksohtmlclip_image10.png) ![](http://img.everychina.com/nimg/c3/a3/19a2430313de10f174fcd2832f74.jpg) | Expiration Date | | ![](http://img.everychina.com/nimg/d3/7e/32d94c159055cd0337602797722a.jpg) | Keep away from Sunlight |
![](http://img.everychina.com/nimg/32/6e/89ac5fa76935845d47ed03eb8d8d.jpg) | Manufacturer | | ![](file:///C:UsersLIUHUI~1AppDataLocalTempksohtmlclip_image13.png) ![](http://img.everychina.com/nimg/15/e9/d6db91c6accd9126a66e0bc4fc4c.jpg) | Tests per Kit |
![](file:///C:UsersLIUHUI~1AppDataLocalTempksohtmlclip_image14.png) ![](http://img.everychina.com/nimg/a3/46/4d69c92e44fd6aeacda88c7d8a0c.jpg) | Lot Number | | ![](file:///C:UsersLIUHUI~1AppDataLocalTempksohtmlclip_image15.png) ![](http://img.everychina.com/nimg/2c/aa/280fd44a522c15344be68386243a.jpg) | In Vitro Diagnostic Medical Device |
![](http://img.everychina.com/nimg/a9/f4/75787cfc409c1aa2d0c6899ada9b.jpg) | Keep Dry | | | |
![](http://img.everychina.com/nimg/60/fa/2b39ebf64e205ab5c512f590a373.jpg) | Guangzhou Decheng Biotechnology Co., LTD |
Room 218, Building 2, No.68, Nanxiang Road, Science City, Huangpu
District, 510000, Guangzhou P.R.China |
TEL:+86-020-82557192 |
sales@dochekbio.com |
www.dochekbio.com |
|
![](http://img.everychina.com/nimg/c2/a1/cecf40acd10f9e3b59e9e8c68227.jpg) | CMC Medical Devices & Drugs S.L. | ![](http://img.everychina.com/nimg/78/de/d81b3284b095c603d3f55a46a369.jpg) |
C/ Horacio Lengo Nº 18, CP 29006, |
Málaga, Spain |