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SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) COVID -19 ANTIBODY TEST KIT

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SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) COVID -19 ANTIBODY TEST KIT

China SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) COVID -19 ANTIBODY TEST KIT supplier
SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) COVID -19 ANTIBODY TEST KIT supplier SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) COVID -19 ANTIBODY TEST KIT supplier SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) COVID -19 ANTIBODY TEST KIT supplier

Large Image :  SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) COVID -19 ANTIBODY TEST KIT

Product Details:

Place of Origin: CHINA
Brand Name: LEPU
Certification: CE
Model Number: COVID-19

Payment & Shipping Terms:

Minimum Order Quantity: 20PCS
Price: USD7.2/PC
Packaging Details: 20PCS/ BOX , 1000PCS/CARTON
Delivery Time: 7DAYS
Supply Ability: 100000PCS / DAY
Contact Now
Detailed Product Description

COVID -19 ANTIBODY TEST COLLOIDAL GOLD

Product Name: SARS-CoV-2 Antibody Test Kit (GICA)
Model and Specifications: 20 tests/kit, packed independently
Type of Clinical Tests: clinical validation
Date of Commence of Clinical Tests: February 14, 2020
Date of Completion of Clinical Tests: February 18, 2020
 
SARS-CoV-2 Antibody Test (colloidal gold
immunochromatography)
Product name
SARS-CoV-2 Antibody Test (colloidal gold
immunochromatography)
Model
One test per bag for one person, 20 tests/kit
Intended Use
The product is intended for the qualitative detection of antibody
content against
SARS-CoV-2
in clinical samples
(serum/plasma/whole blood).
Summary
Coronavirus, as a large virus family, is a single positive stranded
RNA virus with envelope. The virus is known to cause major
illnesses such as colds, Middle East Respiratory Syndrome
(MERS), and Severe Acute Respiratory Syndrome (SARS). The
novel virus, now known as SARS-CoV-2, was discovered in
Wuhan virus pneumonia cases in 2019, and was officially named
by the World Health Organization on January 12, 2020. The core
protein of SARS-CoV-2 is the N protein (nucleocapsid), which is a
protein component located inside the virus. It is relatively
conserved among β-coronaviruses and is often used as a tool for the
diagnosis of coronaviruses. ACE2, as a key receptor for
SARS-CoV-2 to enter cells, is of great significance for the research
of viral infection mechanism.
Measurement Principle
The product is based on the principle of antigen-antibody reaction
and immunoassay technique. The test device contains colloidal
gold labeled SARS-CoV-2 recombinant protein, mouse-anti human
IgG antibody immobilized in T2 test area, mouse-anti human IgM
antibody immobilized in T1 test area and the corresponding
antibody in quality control area (C).
During the test, when the SARS-CoV-2 IgM antibody level in the
sample is at or above the limit of detection of the test, the
SARS-CoV-2 IgM antibody in the sample binds to the colloidal
gold labeled SARS-CoV-2 recombinant protein which is pre-coated
on a gold label pad. The conjugates migrate upward through
capillary effect and would be captured by mouse-anti human IgM
antibody immobilized in T1 test area subsequently and this
produces a purple-red band appears in the T1 test area. When the
SARS-CoV-2 IgG antibody level in the sample is at or above the
limit of detection of the test, the SARS-CoV-2 IgG antibody in the
sample binds to the colloidal gold labeled SARS-CoV-2
recombinant protein which is pre-coated on a gold label pad. The
conjugates migrate upward through capillary effect and would be
captured by mouse-anti human IgG antibody immobilized in T2
test area subsequently and this produces a purple-red band appears
in the T2 test area. If it is a negative sample, there is not a
purple-red band appeared in the T1 and T2 test area. Regardless of
the presence or absence of the SARS-CoV-2 antibody in the sample,
a purple-red band will appear in the quality control area (C). The
purple-red band in the quality control area (C) is a criterion for
judging whether there is enough sample and whether the
chromatography process is normal. It also serves as the internal
control standard for reagents.
Components
The product contains 20 tests, one IFU (instruction for use) and one
lot number card.
For each test, it contains one testing strip, one dropper and one
package of desiccant.
The testing strip is composed of one gold standard mat (colloidal
gold labeled SARS-CoV-2 recombinant protein), sample mat,
cellulose nitrate membrane (Mouse-anti human IgM antibody
immobilized in T1 area, Mouse-anti human IgG antibody
immobilized in T2 area; Goat anti-mouse antibody immobilized in
C area), absorbing paper, plastic carrier board.
Storage and Stability
It should be stored at 4~ 30, be kept dry and away from
sunlight. The shelf life is 12 months.
For per test strip, it should be used within 1 hour after unsealing.
Production Date and Expiration date are shown in the package
label.
Sample Requirements
The test strip can be performed with serum/plasma/whole blood.
The blood should be collected by professional medical staff, and it
is advised of detecting serum/plasma in priority, and under
emergency conditions or special conditions, the whole blood of
patients can be used for rapid testing.
After collection of samples, it should be tested immediately. It is
forbidden for long time placement of the sample under room
temperature. For whole blood sample, if it can not be tested in time,
it can preserve for 24 hours between 2 and 8. Serum/plasma
samples can be preserved for 3 days under temperature between 2
and 8, and for long time storage, they should be stored under
-20, and it should avoided repeated freeze-thaw cycles.
Before testing, the sample must be restored to room temperature,
ready for application only after homogeneity.
The sample must be returned to room temperature before testing,
and should be used after mixing.
Do not use samples with severe hemolysis, severe lipids, and
jaundice.Test Method
Please read the instruction for use carefully before performing the
test. Before testing, restore the reagents and blood sample to room
temperature.
1.
Remove the test strip from the packaging reagent bag and use
it within 1 hour, especially in an environment with room
temperature higher than 30 ° C or in high humidity.
2.
Place the kit on a clean platform.
Serum or plasma sample: Add 10 uL of serum or
plasma sample to well A, and then add two drops
(about 80 uL) of sample dilution to well B, and start
timing.
Whole blood sample: Add 20 uL of whole blood
sample to sample well A, and then add two drops
(about 80 uL) of sample dilution to sample well B, and
start timing.
3.
Wait for the fuchsia band to appear. The test results should be
read within 10-20 minutes. Do not read the results after 20
minutes.
The Explanation of the Testing Results
Positive (+): There appear purple stripes in both quality
control area and either area T1 or T2.
Negative (-): There is only one purple stripe in the
quality control area (C), and without purple stripe in
either test area T1 and test area T2.
Invalid: There is no purple stripe in the quality control
area (C), indicating incorrect operating procedures or
the testing strip has already deteriorated. Under this
conditions, it must read the instruction for use again
carefully, and then use the new test strips to test again.
If the problem still exists, stop using this lot number
immediately and contact the local suppliers.
Limitation of Procedure
1.
The test results of this product should be comprehensively
judged by the physician in combination with other clinical
information, and should not be used as the only criterion;
2.
The product is used to test the SARS-CoV-2 antibody of the
tested sample.
Product Performance Index
1 Physical Property
1.1 Appearance
The test card should be clean and integral, no burrs, no damage, no
pollution; the material should be firmly attached; the label should
be clear and not damaged. The sample buffer should be clear
without impurities and flocs.
1.2 Liquid migration speed
The liquid migration speed should be no less than 10mm/min.
1.3 Membrane Strip Width
The membrane strip width of the testing strip should be2.5mm.
1.4 Sample buffer volume
The sample buffer volume should be no less than the indicated
value.
2 Detection Limit
For the detection of sensitivity reference material, the positive
detection rate should be no less than 90%.
3 Negative reference products compliance rate
For the detection of negative reference material, the negative
detection rate should be 100%.
4 Positive reference products compliance rate
For the detection of positive reference material, the positive
detection rate should be 100%.
5 Precision
For the detection of enterprise reference material P2 and P4, the
results should all be positive and the color rendering should be
uniform.
6 Analysis Specificity
6.1 Cross-reactivity: This test device has no cross reactivity with
endemic human coronavirus OC43 antibody, influenza A virus
antibody, influenza B virus antibody, respiratory syncytial virus
antibody, adenovirus antibody, EB virus antibody, measles virus
antibody, cytomegalovirus antibody, rotavirus antibody, norovirus
antibody, mumps virus antibody, varicella-zoster virus antibody,
and mycoplasma pneumoniae antibody.
6.2 Interfering substances:
The test results do not be interfered with the substance at the
following concentration:
bilirubin concentration 250 μmol/l; triglycerides concentration
15 mmol/l; hemoglobin concentration 10 g/dL; rheumatoid
factor concentration 80RU/ml; anti-mitochondrial antibody
concentration80 U/mL; antinuclear antibody concentration
80U/mL; the total IgG concentration 14g/L.
The test results do not be influenced by the following substance:α
-interferon, zanamivir, ribavirin, oseltamivir, and paramivir,
Lopinavir, ritonavir, abidol, levofloxacin, azithromycin, ceftriaxone,
meropenem, tobramycin, histamine hydrochloride, phenylephrine,
oxymetazoline, sodium chloride (containing Preservatives), beclomethasone, dexamethasone, flunisolide, triamcinolone,
budesonide, mometasone and fluticasone.
Precautions
1.
The test device is to be used as an aid in the diagnosis of
SARS-Cov-2. Do not use expired products.
2.
Do not freeze or use after the expiration date (see the
packaging for the expiration date).
3.
Avoid excessive temperature and humidity in the
experimental environment. The reaction temperature should
be 15-30 ° C and the humidity should be below 70%.
4.
The package bag contains desiccant, and it should not be
taking orally.
5.
It is recommended to use fresh blood for the sample
collection. It is not recommended to use high-fat chyle,
jaundice, and high rheumatoid factor samples. Do not use
hemolyzed samples.
6.
When testing, please wear protective clothing, gloves and eye
shields.
7.
Do not use the test card with broken single packaging,
unclear marks, and past the expiration date.
8.
Dispose of used specimens, test cards and other waste in
accordance with relevant local laws and regulations.
Explanation of Symbols
DO NOT USE IF
PACKAGE IS
DAMAGED
CONSULT
INSTRUCTIONS
FOR USE
DO NOT REUSE
EXPIRY DATE
TEMPERATURE LIMIT
DATE OF
MANUFACTURER
MANUFACTURER
BATCH CODE
KEEP AWAY FROM
SUNLIGHT
KEEP DRY
IN VITRO
DIAGNOSTIC
MEDICAL DEVICE
CE MARK
AUTHORIZED
REPRESENTATIVE IN
THE EUROPEAN
COMMUNITY
References
[1] Aiping Wu, Yousong Peng, Baoying Huang, Xiao Ding,
Xianyue Wang, Genome Composition and Divergence of the Novel
Coronavirus (SARS-CoV-2) Originating in China. Cell Host &
Microbe 27, March 11, 2020
[2] Diagnostic and Treatment Protocol for COVID-19 (Provisional
5th Edition, Amendment Edition), 2020.2.8.

Contact Details
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Tel: 0086-18024853446

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