Mart for Covid-19 wholesale

HOTLINE: 4008765098
Tel/WhatsApp:+8618930311251      e-mail: cs@ppeon.com
USA office: +1-628-7778111            India office: gef001@gmail.com
More PPE  > Sourcing Everything For you, reliable!
Product Detail
COVID-19 Antigen Rapid Test Kit with CE certificate: result in 10 min
Collection
COVID-19 Antigen Rapid Test Kit with CE certificate: result in 10 min
Price:
$1.15
$5.00
Collection:0
Quantity:
库存量:9999999
Detail

Product Name

SARS-CoV-2 (COVID-19) Antigen Rapid Test Kit (Colloidal Gold)

Package Specification

25 tests/kit & 50 tests/kit

Intended Use

This kit is intended to be used for the qualitative detection of SARS-CoV-2 antigen in human respiratory specimens, sputum and other samples. This kit uses cellulose membrane immunochromatography technology. Antigen detection is used for auxiliary diagnosis or epidemiological investigation of human infection with SARS-CoV-2.

Principle

The kit adopts cellulose membrane immunochromatography technology and applies the principle of membrane chromatography double antibody sandwich method to detect the SARS-CoV-2 antigens in human samples. The product consists of sample well and detection area on the Detection Strip. The Detection strip contains coated anti-SARS-CoV-2 monoclonal antibody, colloidal gold particles labeled with anti-SARS-CoV-2 monoclonal antibody, and goat anti-mouse polyclonal antibody. When SARS-CoV-2 antigens are present in the sample, the SARS-CoV-2 antigens will combine with the colloidal gold-labeled anti-SARS-CoV-2 monoclonal antibody, it will be captured by the coated anti-SARS-CoV-2 monoclonal antibody. When the viral antigen crosses the T region of detection line, it will be captured by the coated anti-coronavirus monoclonal antibody, which will gather and develop color in the detection area. Conversely, if SARS-CoV-2 antigens are not present in the sample or the antigen titer is below the limit of detection, there will be no color band appearance on the detection line and the result will be negative. Regardless of whether the sample contains antigens of the SARS-CoV-2, a color band should appear on the quality control region (C region)line of the detection area. The quality control band is the standard for judging whether the inspection process is normal and it also serves as the internal control standard for the Detection Strip.

Components of the Kit

Components

25T

50T

1.     SARS-CoV-2 test card

25 pcs

50 pcs

2.     Disposable sampling tube(with sample diluent buffer)

25 pcs

50 pcs

3.     Disposable sampler

25pcs

50 pcs

4.     Instructions

1 copy

1 copy

Note: The components in the kits of different batch numbers are not interchangeable.

The materials and instruments necessary for the test but not provided are as follows: Lancet;

Absorbent paper or similar material; Timer;

Micro pipette corresponding to the range;

Laboratory safety protection equipment such as disposable gloves, etc.

Storage and Shelf Life

Stored at 2°C ~ 30°C, and kept away from direct sunlight. The validity period is 12 months.

After the aluminum foil bag is opened, the Detection Strip should be used within 1 hour. The Sample Diluent Buffer should be capped immediately after usage. Usage after the date of expiration is not recommended.

Date of manufacture & expiration are indicated on the label and package.

Sample Requirements

Sample type: nasal swabs, throat swabs, deep cough sputum, respiratory tract extracts, bronchial lavage fluid, alveolar lavage fluid, etc. Sample collection: the collection and testing of patient samples must be performed in accordance with the “Guidelines on Laboratory Testing Techniques for COVID-19 Caused by SARS-CoV-2” (The 4th edition) released by the National Health Commission. Sample processing :

1. Take 500 µL (deep cough sputum, respiratory tract extract, bronchial lavage fluid, alveolar lavage fluid) from sample to be tested, mix it with 500 µL of sample diluent solution (1:1), and then take 100 µL into the sample well for testing ;

2.Samples such as nasal swabs or throat swabs are directly put into 500 µL sample diluent solution, mixed thoroughly, and then about 100 µL the supernatant is taken for testing.

Sample storage: the samples should be processed for testing in time after collection; if not, they should be stored in accordance with the requirements of the “Guidelines on Laboratory Testing Techniques for COVID-19 Caused by SARS-CoV-2” (The 4th edition) released by the National Health Commission.

Sample safety: all samples should be treated as potentially infectious materials and subject to the relevant standards and guidelines.

Experiment Workflow

Please read the instruction for use carefully before using this kit. All reagents should be incubated at room temperature (10-30°C) for 30 minutes prior to use. The test should be carried out at room temperature and the operation procedure is described below:

1. Open the sealed bag and remove the Detection Strip. Mark the sample ID on the test strip and lay the strip flat on the table.

2. Specimen collection

1).Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx, that presents the most secretion under visual inspection.

2).Swab over the surface of the posterior nasopharynx. Rotate the swab several times.

3).Withdraw the swab from the nasal cavity.



3. Sample preparation

1). Insert the sample diluent tube into the pipe rack, make sure that the tube is standing firm and reaches the bottom of the pipe rack.

2). Open the purple cap of the sample diluent tube. Insert the swab into the diluent tube which contains 0.5 mL of the diluent buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the diluent tube.

3). Leave the swab in the diluent tube for 1 minute.

4). Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab,close the cap. The diluent solution will be used as test sample.

5). Open the small cap on the top of the sample dilution tube. Add 3-4 drops (~100 μL) of the sample diluent buffer immediately to the sample well.

6).Allow the strip to develop for 10-15 minutes at room temperature. A visible band can be read by naked eyes.


Insert the sample diluent tube into the pipe rackOpen the cap, insert the swab and roll the swabLeave the swab in the diluent tube for 1min minuteSqueeze the tube several timesSqueeze the tube several times, close the capOpen the small cap, add3-4 drops of the buffer to the sample well
Results Analysis

The interpretation of visual interpretation results (as shown below):

1. The results can be read directly by naked eyes as shown in the figures below: Positive result: a visible band can be seen in both line C and line T.



2. Negative result: A visible band can be seen in line C only.



3. Invalid result: A visible band cannot be seen in line C, and the test must be repeated using a new strip.



Cut- off Value

1. Determination of the cut-off value, the product is a qualitative detection kit of antigens to the SARS-CoV-2. When the quality control line (C line) and the test line (T line) are formed, regardless of a weak T line, as long as it is visible to the normal naked eyes, the test result should be judged as positive.

2. The test for the normal population should be negative. Positive test results indicate that an individual may have been exposed to SARS-CoV-2, and should be combined with clinical symptoms and other diagnostic results for further confirmation.


Interpretation of test Results

1. Common mistakes that may lead to false positive or negative results include: the kit is used after its expiration; the kit has been improperly stored; the operating temperature is too low (<2°C) or too high (>30°C); the procedures outlined in this protocol were not strictly adhered to.

2. Any final clinical interpretation should consider a combination of test results, clinical symptoms, and other indicators.


Limitations of Inspection Methods

1. If the patient has clinical symptoms but the test result is negative , it is recommended to use PCR method for confirmation and the doctor will make a comprehensive judgment to confirm the diagnosis. The negative result cannot be the only evidence to rule out the SARS-CoV-2 infection.

2. The product can only be used for clinical diagnosis and on-site screening of the SARS-CoV-2. The positive results of all Detection Strips must be confirmed by a qualified laboratory. Positive result of antigen detection should be combined with other clinical features to ensure accurate diagnosis.

3. In order to ensure the accuracy of the SARS-CoV-2 antigens detection, high temperature and humidity must be avoided.

Performance Characteristics

1. Lowest detection limit The lowest detection limit of the kit is 0.005 ng/ml.

2. A total of 564 cases of Nasopharyngeal swabs samples tested in this clinical trial, and the clinical trial results are as follows:

PCR Results
Test Kits

Positive

Negative

Total

Positive

243

0

243

Negative

5

316

321

Total

248

316

564

Clinical sensitivity coincidence rate = 97.98%(CI*95%:95.37% - 99.14%);

Clinical specificity coincidence rate = 100%(CI*95%:98.8% - 100.00%);

Total coincidence rate =99.11%.(CI*95%:97.9% - 99.6%).

*CI confidence interval

Cross Reactivity

No false positive SARS-CoV-2 test results were observed on 1-36 specimens from the following disease states or specific conditions, respectively:


Virus/Bacteria

Result

Virus/Bacteria

Result

Staphylococcus aureus

Negative

Epstein-Bar r virus

Negative

Streptococcus pyogenes

Negative

Enterovirus CA16

Negative

Measles virus

Negative

Rhinovirus

Negative

Mumps virus

Negative

Respiratory syncytial virus

Negative

Adenovirus 3

Negative

Streptococcus pneumoniae

Negative

Mycoplasma pneumoniae

Negative

Candida albicans

Negative

Parainfluenza virus 2

Negative

Chlamydia pneumoniae

Negative

Human Metapneum ovirus
(hMPV)

Negative

Bordetella pertussis

Negative

Human coronavirus OC43

Negative

Human coronavirus NL63

Negative

Human coronavirus 229E

Negative

Pneumocystis jirovecii

Negative

Bordetella parapertussia

Negative

Mycobacterium tuberculosis

Negative

Influenza B (Victoria strain)

Negative

Human coronavirus

Negative

Influenza B (Y strain)

Negative

HKU1

Negative

Influenza A (H1N1, 2009)

Negative

Legionella pneumophila

Negative

Influenza A (H3N2)

Negative

Haemophilus influenzae

Negative

Avian influenza virus (H7N9)

Negative

Parainfluenza virus 1

Negative

Avian influenza virus (H5N1)

Negative

Parainfluenza virus 3

Negative

Parainfluenza virus 4b

Negative

MERS- coronavirus

Negative

Precations

1. This product is a disposable in vitro diagnostic reagent. Do not reuse. Do not use this kit if it is expired.

2. In order to obtain the correct test results, the test should be operated strictly according to the Instruction for Use.

3. The Detection Strips and Sample Diluent Buffer should be brought up to room temperature before use.

4. All test samples and waste should be treated as infectious and disposed of in accordance with local regulations.

5. The kit should be stored at 2-30℃.Do not freeze, avoid heavy pressure during storage and keep away from moisture, light and heat.

6. When transporting at room temperature, light handling, light loading and unloading, avoiding heavy pressure, waterproofing and high temperature resistance must be observed during transportation.

7. It is recommended to use fresh samples instead of repeated freeze-thaw samples. Pay attention to safety measures during operation, such as wearing protective clothing and gloves.

8. Desiccant is contained in the aluminum foil bag. Do not ingest.


CE certificate below:


1.png

PAYMENT METHOD

COMPANY TRANSFER
CASH ON DELIVERY
ONLINE PAYMENT
HIRE PURCHASE
MERCHANT SERVICE

MERCHANTS SETTLED
TRAINING CENTER
ADVERTISING SERVICES
SERVICE MARKET
SERVICE GUARANTEE

QUALITY ASSURANCE
PAYMENT TERM SUPPORT
DELIVERY GURANTEE
7X15 HOUR CUSTOMER SERVICE
China office: #1000 Pingliang Road, Shanghai
USA office: #2329 E Greenview Dr Grendora CA
Hongkong: PPEON ASIA LIMITED
Account: 77722200823013747 SWIFT: Citibank
PPE Online
SHANGHAI HUB INT‘L TRADING