COVID-19 IgGIgM Rapid Test Kit

«SHOLASSI» COVID-19
IgG/IgM Rapid Test Kit

(Whole Blood)

 

For the qualitative assessment of Coronavirus Disease ( Covid-19 or 2019-nCOV) IgG/IgM in whole blood.

For professional In Vitro Diagnostic Use Only.

 

INTENDED USE:

«Sholassi» COVID-19 IgG/IgM Rapid Test Kit (Whole Blood) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies of Coronavirus Disease 2019 in human whole blood.

 

SUMMARY:

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious

disease. People are generally susceptible. Currently, the patients infected by the novel

coronavirus are the main source of infection; asymptomatic infected people can also be an

infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough.

Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

 

 

PRINCIPLE:

This kit uses immunochromatography. The test card contains: 1) colloidal gold-labeled

recombinant novel coronavirus antigen and quality control antibody gold markers; 2) two

detection lines (IgG and IgM lines) and one quality Control line (C line) of nitrocellulose

membrane. The IgM line is immobilized with a monoclonal anti-human IgM antibody for

detecting a novel coronavirus IgM antibody; the IgG line is immobilized with a reagent for

detecting a novel coronavirus IgG antibody; and the C line is immobilized with a quality control antibody.  When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains an IgM antibody, the antibody will bind to the colloidal gold-labeled recombinant protein. The immune complex will be captured by the anti-human IgM antibody immobilized on the membrane to form a purple-red IgM line, showing that the novel coronavirus IgM antibody is positive. If the sample contains an IgG antibody, the antibody will bind to the colloidal gold-labeled recombinant protein, and the immune complex will be captured by the reagent immobilized on the membrane to form a purple-red IgG line, indicating that the novel coronavirus IgG antibody is positive. If the test IgG and IgM lines are not colored, a negative result is displayed. The test card also contains a quality control line C. The fuchsia quality control line C should appear regardless of whether a test line appears. The quality control line is a color band of the quality control antibody immune complex. If the quality control line C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.

 

 

REAGENTS:

The test contains COVID-19 virus spike protein，nuclear protein particles and anti-human IgG, anti-human IgM antibody conjugated gold particles coated on the membrane.

 

 

 

PRECAUTIONS:

 

1. For professional in vitro diagnostic use only. Do not use the kit beyond the expiration date.

2. Do not eat, drink or smoke in the area where the specimens or kits are handled.

3. Do not use the test if the pouch is damaged.

4. Handle all specimens as if they contain infectious agents. Observe established precautions

against microbiological hazards throughout testing and follow the standard procedures for

proper disposal of specimens.

5. Wear protective clothing such as laboratory coats, disposable gloves and eye protection

when specimens are being tested.

6. The used test should be discarded according to local regulations.

7. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been

in contact with the virus. Follow-up testing with a molecular diagnostic should be considered

to rule out infection in these individuals.

8. Result from antibody testing should not be used as the sole basis to diagnose or exclude

SARS-CoV-2 infection or to inform infection status.

9. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus

strains, such as coronavirus HKU1, NL63, OC43, or 229E.

 

STORAGE AND STABILITY:

1. The original packaging should be stored at 2-30℃, to avoid light, keep dry.

2. The test device is stable through the expiration date printed on the sealed pouch. The test

device must remain in the sealed pouch until use. DO NOT FREEZE.

3. Do not use beyond the expiration date, especially at temperatures above 30℃ or under high humidity conditions, should be used immediately once it is opened.

 

SPECIMEN COLLECTION AND PREPARATION:

1. The 2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) is intended for

use with human whole blood specimens only.

2. Only clear, non-hemolyzed specimens are recommended for use with this test

3. Perform testing immediately after specimen collection. Do not leave specimens at room

temperature for prolonged periods. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days after collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

4. When collecting finger stick blood with a lancet and alcohol pad, the first drop of

blood should be discarded.

5. Bring specimens to room temperature prior to testing.

 

MATERIALS SUPPLIED

 

·         Test Device

·         Buffer

·         5μL Disposable plastic pipette

·         Lancets (for finger stick whole blood only)

·         Alcohol pad

·         Package insert

 

 

DIRECTIONS FOR USE:

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C)

prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the

sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface.

 For Whole Blood (Venipuncture/Fingerstick) Specimens:

Using the provided 5μL disposable pipette, and transfer 2 drops of whole blood (approximately 20μL) to the specimen well of the test device, then add 1 drop of buffer,and start the timer.

Note: Specimens can also be applied using a micropipette.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the

result after 15 minutes. 

 

INTERPRETATION OF RESULTS:

IgG POSITIVE: *The colored line in the control line region (C) appears and a colored line

appears in test line region IgG. The result is positive for COVID-19-IgG antibodies.

IgM POSITIVE: *The colored line in the control line region (C) appears and a colored line

appears in test line region IgM. The result is positive for COVID-19-IgM antibodies and is

indicative of primary COVID-19 infection.

IgG AND IgM POSITIVE: *The colored line appears in the control line region (C) and two test

line regions (IgG and IgM). The result is positive for COVID-19-IgG and COVID-19-IgM

antibodies.

*NOTE: The intensity of the color in the test line region(s) IgG and/or IgM may vary depending

on the concentration of COVID-19 antibodies in the specimen. Therefore, any shade of color in the test line region(s) IgG and/or IgM should be considered positive.

NEGATIVE: The colored line in the control line region (C) appears. No line appears in test

line region IgG or IgM.

INVALID: There is no line appeared in the C region.

Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for

control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

 

QUALITY CONTROL:

Internal procedural controls are included in the test. A color line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

 

 

LIMITATIONS OF USE:

1. The accuracy of the test depends on the sample collection process. Improper sample

collection, improper storage of samples, stale samples, or repeated freeze-thaw cycles of

samples will affect the test results.

2. The test cassette only provides qualitative detection of the COVID-19 antibody in the sample. If you need to detect the specific content of an indicator, please use the relevant professional instruments.

3. The test result of this kit is for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment responses.

4. It is recommended to review the suspicious negative results by using nucleic acid detection

or virus culture identification methods.

5. Analysis of the possibility of false negative results

1. Unreasonable sample collection, transportation and processing may lead to false negative

results.

2. Genetic variations of virus can cause changes in antibody determinants, which can lead to

false negative results.

3. The optimal sample type and sampling time after infection have not been verified, so

collecting samples at different times on the same patient may avoid false negative results.

 

Produced by the order and under the control of «Giga Farm» LLC. 3101, Republic of Armenia, Shirak region, c. Gyumri, Gogunts street, 3/5.Website: www.gigafarm.ru ; E-mail: gig.am@mail.ru,

Tel: +37494000264, +37494000265. «Sholassi» is registered trademark of «Giga Farm» LLC. Manufacturer: «Hangzhou Realy Tech Co.» Ltd. #2 Building, No 763, Yuansha village, Xinjie Street Xiaoshan District, 311200 Hangzhou City, Zhejiang Province, PEOPLE’S REPUBLIC OF CHINA.