Coronavirus Rapid Test Kit, COVID-19 Antibody Test Kit, COVID-19 Rapid Test Kit IgG + IgM, 96% Accuracy in 10-15 Minutes, Made in UK, 2 Complete Tests in One Kit

Intended Use: 
The 2019-nCoV IgG/IgM Device is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV, a new strain of coronavirus (nCoV), in whole blood, serum and plasma specimen. 
Summary: 
Coronaviruses are a large family of viruses that cause disease ranging from common cold symptoms to more severe pneumonia. They are enveloped single-strand RNA viruses. Coronaviruses are zoonotic, they can be transmitted from animals to humans. Existing examples include the Middle East Respiratory Virus (MER-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).  
Reports of a novel coronavirus began in the Wuhan district of China in December 2019 and in January 2020 the World Health Organisation designated the new strain 2019-nCoV. Symptoms include high temperature, cough, and breathing difficulties. In immunocompromised individuals, symptoms can be more severe leading to pneumonia, severe acute respiratory syndrome, or death.  
Test Principle: 
The test device has anti-human IgG and anti-human IgM immobilized on the membrane in two distinct areas of the test zone. Particles coated with 2019-nCoV antigen are loaded on the membrane near the sample well. During the test whole blood, serum, or plasma sample is added to the sample well where it interacts with the antigen-coated particles and any antibodies to 2019-nCoV present in the sample will bind to the antigen. The antibody-particle complexes migrate up the membrane by capillary action where they interact with the anti-human IgG and/or anti-human IgM in the test zone and are captured. A positive result is indicated when a colored line forms at the IgG and/or IgM test line. The absence of any line development at the test zone indicates a negative result. To serve as a procedural control, a colored line should always appear at the control line area indicating that proper volume of specimen has been added and membrane wicking has occurred. 
Reagents: 
The test device contains anti-human IgG, anti-human IgM, 2019-nCoV antigen, and goat anti-mouse IgG on the membrane of the 2019-nCoV IgG/IgM Rapid Test. 
Materials Provided 
Individually pouched test devices 2
Droppers 2
Buffer 
Materials not provided: Timer, specimen collection container, centrifuge
 

Warnings: 
Follow Good Laboratory Practice procedures where samples and kits are handled and treat the device and all samples as if potentially infectious. Follow local regulations for correct disposal of samples. 
Wear protective clothing including laboratory coat, disposable gloves, and safety glasses when conducting the test. 
Humidity and temperature can adversely affect results. 
Storage and Stability: 
The kit can be stored at room temperature or refrigerated (2 - 30oC). The test device is stable up to the expiry date printed on the sealed pouch. The device must remain in the sealed pouch until use. Do Not Freeze. Do not use after the expiry date. The stability of the buffer is approximately six months after opening the bottle.  
Sample Collection and Preparation: 
The 2019-nCoV IgG/IgM Device test can be performed using whole blood, serum, or plasma. 
To collect Finger prick Whole Blood samples: Clean an area of the patient’s fingertip with an alcohol swab. Allow drying. Squeeze the hand gently to encourage blood flow to the finger. Pierce the skin with a sterile lancet and wipe away the first sign of blood. Gently squeeze the hand again then the finger to release a large drop of blood over the puncture site. Collect the blood drop in the dropper. Do not freeze whole blood samples. Whole blood collected by finger prick must be tested immediately. 
Assay Procedure: 
Bring the device, samples, buffer, and controls fully to room temperature (15 - 30C) before starting any testing. Remove the test device from the sealed pouch, place it on a clean and level surface, and use it immediately. 
NOTE: The intensity of color development at the test lines will vary depending on the concentration of anti-2019-nCoV IgG or anti-2019-nCoV IgM present in the sample. Therefore, any shade of color developing at the test lines should be considered positive. 

100% UK Made
All parts (antigen, membrane, plastic parts) are manufactured in the UK.
AMS Labs UK
APPROVED BY TURKISH MINISTRY OF HEALTH
Coronavirus Rapid Detection Kit is a chromatographic immunoassay for the rapid qualitative detection of IgG and IgM antibodies in the blood, serum, or plasma samples.
Usage:
1- With the small scalpel included in the kit, carefully open a very small incision on your finger.
2- Then, clean the first drop of blood and disinfect the cut area with the attached alcohol swab.
3- Take 1 drop of blood with the dropper and drop it on the Sample (S) area on the cassette.
4- Then add 2 drops of the attached solution and wait for 10 minutes
5- After 20 minutes, all appeared results are invalid.
The volume of one drop of blood applied to the device should be the same size as the drop of solution used.
Using just one drop of the solution, three drops of the solution, or any amount more or less than the recommended amount will result in an invalid test result.

Single-Use Parts: (Parts 1-3-4-5)
For the solution, Part # 2, is in the box containing two test strips that are used in common for these two strips.
Storage:
Keep in a dry and cool place within a temperature range between 2-30 ° C.

Results:
1- Negative
Clear - C
The result shows that the immune system does not produce antibodies for Covid-19. That is, the person is not infected with the virus.
If the PCR test is positive and the test kit nevertheless gives this result, then this means that the person has passed Covid-19 without producing antibodies.
If you have had Covid-19 before, this result indicates that the body is not immune.
It has been observed that 20-30% of those exposed to Covid-19 developed the disease without producing antibodies and without symptoms.
2- POSITIVE
IgM
It indicates that the body was caught the virus at least 3-7 days ago. The immune system uses the IgM antigen between 3-10 days.
3- POSITIVE
IgM + IgG
It indicates that the body caught the virus 7-10 days ago and the immune system is intensely fighting the virus.
4- Negative
IgG
The IgG antibody also indicates that the virus has cleared from the body and that the body is immune to the virus.

The IgM antigen is one of the first reactions of the immune system after macrophages and is found in 15 percent of the blood.
IgG antibody is produced when the IgM antigen is not sufficient and is found in 75 percent of the blood.
When infection with the disease without symptoms, the IgG antibodies disappear after a while, but since the virus was recorded in the immune memory, the body produces IgG antibodies immediately in the event of re-infection with the virus.
In the PCR tests that monitor the RNA of the virus, obtaining negative results 2 times in a row and obtaining IgG in the antibody test shows the same result: The virus has decreased to a level that cannot be detected.
IgG status is also defined as Positive, but this only indicates that the person has been infected.
Examples of invalid test results
C is the validity criterion for the test and any results without a C index are invalid.

Common questions about in Coronavirus Rapid Test Kit, COVID-19 Antibody Test Kit, COVID-19 Rapid Test Kit IgG + IgM, 96% Accuracy in 10-15 Minutes, Made in UK, 2 Complete Tests in One Kit   Turkey:

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FAQ:
Q1: What is the intended use of the 2019-nCoV IgG/IgM Device?

A1: The device is used for the rapid qualitative detection of IgG and IgM antibodies to 2019-nCoV in whole blood, serum, and plasma specimens.

Q2: What are coronaviruses and how do they spread?

A2: Coronaviruses are a family of viruses causing various diseases. They are zoonotic, transferring from animals to humans. Examples include MER-CoV and SARS-CoV.

Q3: How does the test work?

A3: The test device contains specific antibodies and antigens. When a blood sample is added, antibodies to 2019-nCoV, if present, bind to antigens on the device, resulting in colored lines indicating a positive result.

Q4: What symptoms are associated with 2019-nCoV?

A4: Symptoms include high temperature, cough, breathing difficulties, and in immunocompromised individuals, severe conditions like pneumonia or severe acute respiratory syndrome.

Q5: How should I collect a finger prick whole blood sample?

A5: Clean the finger, puncture the skin with a sterile lancet, collect a drop of blood with a dropper, and apply it to the sample area on the cassette.

Q6: How do I interpret the test results?

A6: Any shade of color developing at the test lines should be considered positive. No line development indicates a negative result.

Q7: How should I store the kit?

A7: The kit can be stored at room temperature or refrigerated (2 - 30°C). The test device must remain in the sealed pouch until use. Do not freeze.

Q8: What should I do if I get an invalid test result?

A8: Using an incorrect amount of blood or solution may lead to an invalid test result. Follow the instructions carefully.

Q9: Is the test approved by health authorities?

A9: Yes, the test is approved by the Turkish Ministry of Health.

Q10: How long does it take to get the test result?

A10: After adding the solution, you should wait for 10 minutes to interpret the result. Any results appearing after 20 minutes are invalid.

Q11: Is the test kit manufactured in the UK?

A11: Yes, all parts of the test kit, including the antigen, membrane, and plastic parts, are manufactured in the UK.

Q12: Can I use the test for diagnosing coronavirus?

A12: The test is intended for the qualitative detection of IgG and IgM antibodies and is not a substitute for professional medical diagnosis.