Covid-19


Test Kit

Covid-19


Test Kit

Home coronavirus test finally available in France!

Because it is unbearable not to know and it is aberrant that screening is not available in mass.

Introduction

The coronavirus pandemic has been in stage 3 since March 14, 2020 in France. Cases showing signs of Covid-19 are no longer systematically classified and confirmed by biological tests (RT-PCR SARS-CoV-2).

Due to a lack of available means, patients are refused to be tested and these tests are reserved only for people with signs of severity and for professionals with symptoms.

Detecting coronavirus with a diagnostic test is essential to limit its spread. Countries having successfully managed the epidemic, such as Korea and Iceland, have shown that the containment strategy is not enough and mass testing is essential.

If you have clinical signs such as cough, fever, aches and pains, it is essential to test you and your family to find out if it is the Coronavirus that is affecting you. If you test positive, you should then contact your doctor.

It is believed that in 80% of cases people infected with coronavirus have a mild form of the disease or no symptoms. It is essential for the success of the containment to know if one is a healthy carrier of the Coronavirus in order not to contaminate others.

The test is essential and it is up to you to organize yourself in the face of the deficiencies of the health care system!

This is why WorldPRP, world leader in Platelet Rich Plasma, has decided to import a rapid test COVID19 IgM. Unique in Europe, and very easy to use, this test is manufactured by one of the largest Chinese companies in the field of medical equipment

The test detects and captures by immunochromatography the antibodies produced by your own body in the presence of the Coronavirus. Reliable at 92.3%, this qualitative test comes in the form of a simple card. Just take two drops by pricking your fingertip and add two more drops of reagent.

In case of a positive test, two red bars appear within 15 minutes. The test is negative if only one line appears in the control area.

Special offer: the detection kit only at 39.90 EUROS

Until April 15th, get 20% discount on the normal price of 50 EUROS, postage included in Metropolitan France and Switzerland.

Attention, we ship the kits in the order of arrival of the customer’s order. Due to an important influx and possible troubles at the post office, allow 10 days to receive your order.

Technical Details

Name
COVID-19 IgM Antibody Rapid Test Kit (Immunochromatography)

Intended use

The reagent is used to detect the Corona Virus-19 IgM Antibody in serum/plasma/whole blood qualitatively.

Test principle
This kit is based on the principle of gold label immunochromatographic test and uses capture method to detect the COVID-19 IgM antibody in the sample.
When the sample contains the COVID-19 IgM antibody, it forms a complex with the gold label antigen (COVID-19 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibody (Mouse anti-human IgM monoclonal antibody) at the T line to form a complex and develop color (T line), which is a positive result. When the sample does not contain the COVID-19 IgM antibody, no complex can be formed at the T line, and no red band appears, which is a negative result.
Regardless of whether the COVID-19 IgM antibody is contained in the sample, the gold label quality control antibody (rabbit IgG antibody) will bind with the coated antibody (goat anti-rabbit IgG antibody) at the C line to form a complex and develop color (C line).

Main components
Cassette: T-line coated with mouse anti-human IgM monoclonal antibody, gold label pad solid phase COVID-19 recombinant antigen, rabbit IgG antibody, C-line coated with goat anti-rabbit IgG antibody
Sample dilution: composed of 20 mM phosphate buffer solution (PBS)

Storage and expiry
Store as packaged in the sealed pouch at 4-30℃, avoid hot and sunshine, dry place, valid for 12 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze- thaw. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity>60%.

Requirement
1. The reagent can be used for the serum, plasma and whole blood samples.
2. A serum / plasma / whole blood sample must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as anticoagulants in plasma / whole blood samples. Detect immediately after collecting blood.
3.Serum and plasma samples may be stored at 2-8℃ for 3 days prior to assay. If testing is delayed more than 3 days, the sample should be frozen (-20℃ or colder). Repeat freeze and thaw for no more than 3 times. Whole blood samples with anticoagulant can be stored at 2-8℃ for 3 days, and should not be frozen; whole blood samples without anticoagulant should be used immediately (if the sample has agglutination, it can be detected by serum).

Test methods
Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity>60%.

For Whole Blood
1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.
2. Add two (2) full drops of whole blood (20μl) vertically into the sample well.
3. Add two (2) drops (80-100μl) of sample buffer into the sample well.
4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

Interpretation of results
POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
NEGATIVE: One red line appears in the control region(C). No red or pink line appears in the test region (T).
INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Limitations
1. This reagent is designed for the qualitative screening test. Concentration of COVID-19 IgM antibody cannot be determined by this qualitative test. The depth of the T-line color is not necessarily related to the concentration of the antibody in the sample.
2. The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.

Performance Characteristics

Analysis of coincidence rate of COVID-19 IgM Ab rapid test and nucleic acid reagent in serum samples:
Positive coincidence rate=41 / (41+9) × 100% = 82%,
Negative coincidence rate=282 / (18+282) × 100% = 94%,
Total coincidence rate=(41+282) / (41+9+18+282) × 100% = 92.3%.

Attentions
1. For IN VITRO diagnostic use only.
2. Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
3. The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.
4. All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.

Manufacturer
Guangzhou Medsinglong Medical Equipment Co., Ltd.
Add: Rm 405, South China Building, West Fuhua Road,
Shiqiao Town,Panyu,Guangzhou,511405 P.R China
Tel: +0086-20-84899760

Importer HLPRODUCTION SA, 12 Rue du Vieux Collège, 1204 Switzerland. Public limited company registered in the trade register of the State of Geneva under the number IDE: CHE 265.701.279.