Coretests® COVID-19 IgM/IgG Ab Test

Format: Cassette

Specimen: Serum/Plasma/Whole blood

INTENDED USE

Coretests® COVID-19 IgM/IgG Ab Test is used for qualitative detection of the IgM and IgG antibodies of SARS-CoV-2 (COVID-19) in human serum/plasma or whole blood. Auxiliary diagnosis of SARS-CoV-2 (COVID-19).

INTRODUCTION

Coronavirus (CoV) is mainly transmitted through direct contact with secretions or through aerosols and droplets. Evidence suggests transmission via fecal-oral route. Seven CoVs caused human‘s respiratory diseases are found by now: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-CoV-2, which represent serious pathogens for human’s respiratory diseases. SARS-CoV-2 was found in the viral pneumonia pandemic in the world (COVID-19). COVID-19 clinical manifestations include fever, enervate and systemic symptom, with dry cough, difficult breathing etc. and it may aggravate to severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock, multiple organ failure, severe acid-base metabolic disorders and even death.

PRINCIPLE

Coretests® COVID-19 IgM/IgG Ab Test, engineered with a principle that involves antibody-antigen reaction, nano-colloidal gold and immunochromatography technology, is designed for qualitative detection of the IgM and IgG antibodies of SARS-CoV-2 in human serum, plasma or whole blood. Mouse anti-human IgM antibodies, mouse anti-human IgG monoclonal antibodies and goat anti-mouse IgG polyclonal antibodies (internal control) are respectively immobilized on a nitrocellulose membrane, which react to colloidal gold-labeled recombinant antigens of the SARS-CoV-2 and mouse IgG (internal control).

During the testing, SARS-CoV-2 IgM antibody in the sample captures the colloidal gold-labeled SARS-CoV-2 recombinant antigen to form an antigen-antibody complex, which was then bound to the mouse anti-human IgM monoclonal antibody coated in the M line during sample lateral flow. As a result, a red M line will appear. When SARS-CoV-2 IgG antibody in the sample captures the colloidal gold-labeled SARS-CoV-2 recombinant antigen to form an antigen-antibody complex, which is then bound to the mouse anti-human IgG monoclonal antibody coated in the G line during sample lateral flow. As a result, a red G line will appear. If the samples do not contain SARS-CoV-2 IgM or IgG antibodies, colloidal gold-labeled SARS-CoV-2 recombinant antigen cannot be bound to mouse anti-human IgM or IgG monoclonal antibodies in the M and G line regions. As a result, there is no red line in either M or G line positions. When the sample has been transported properly to the C line, regardless what antibodies are present in the sample, colloidal gold labeled mouse IgG (internal control) should be bound to goat anti-mouse IgG polyclonal antibodies coated in the C line, and a red C line should appear. No supporting instrument or card reader is required for Coretests® COVID-19 IgM/IgG Ab Test.

MATERIALS PROVIDED

Coretests® COVID-19 IgM/IgG Ab Test contains the following items to perform the assay:

  • COVID-19 IgM/IgG Ab Test Cassette
  • Instruction for use
  • Buffer
  • Pipette(Optional)

MATERIALS REQUIRED BUT NOT PROVIDED

  • Clock or Timer
  • Sample container
  • Glove
  • Sterile lancet(Optional)

WARNING AND PRECAUTIONS

1. Read instruction carefully before performing this test.
2. For in vitro diagnostic use only.
3. Do not use the test cassette beyond the expiration date.
4. The test cassette should remain in the sealed pouch until use. Do not use the test
cassette if the pouch is damaged or the seal is broken.
5. Do not reuse the cassette.
6. Properly treat and handle the specimens and used test cassettes as if they were
potentially infectious. Dispose all specimens and used cassettes in a proper bio-hazard container. The handling and disposal of the hazardous materials should follow local, national or regional regulations.
7. Do not mix and interchange different specimens.
8. Wear disposable gloves, lab coat and eye protection while handling potentially infectious
material and performing the assay. Wash hands thoroughly afterwards.
9. Clean spills thoroughly using an appropriate disinfectant.
10. Keep out of reach of children.
11. Do not swallow the desiccant.
12. Hemolytic samples cannot be used for testing.
13. Do not use turbid contaminated samples for testing.
14. This kit may show negative results under the following conditions, when the SARS-CoV-2
antibody titer in the sample is below the minimum detection limit of the kit, or the SARS-CoV-2 antibody has not been formed by the individual being tested at the time of sample collection.
15. If the test result is positive, further confirmation (infection process or false-positive) is needed. If the test result is negative, the possibility of infection (In window period or false-negative) cannot be ruled out. Comprehensive analysis should be conducted in combination with clinical indicators, and re-examination should be conducted one week later.

SPECIMEN PREPARATION

1. The specimen is human serum/plasma and whole blood, including clinical anticoagulants (EDTA, heparin, sodium citrate) origin prepared plasma or whole blood.
2. Perform the test immediately after specimen collection. Fingertip blood samples should be tested immediately. Serum, plasma, and anticoagulated whole blood are collected, stored at room temperature for no more than 36 hours, at 2 to 8°C for no more than 3 months. Serum /plasma can be stored at -20°C for a long time. Deteriorated samples may affect the results.
3. Pre-warm the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed. The precipitate should be removed by centrifugation prior to the test if clearly visible particles exist in the specimen.
4. Do not perform the test if specimen is turbid or has massive lipid or hemolysis.

TEST PROCEDURE

Read the instruction first prior to testing. Bring the pouched test to room temperature prior to testing. Do not open the pouch until ready to begin testing.
1. Remove the test cassette from the sealed pouch. Lay it on a flat, clean and dry surface.
2. Use the 10μL pipette provided to withdraw the specimen to the marked line. Dispense the specimen to the sample well.
3. Hold the buffer bottle vertically and add 2 drops of buffer(approximate 70μL)to sample well.
4. Read results in 10-15 minutes.

INTERPRETATION OF RESULTS
IgG & IgM Positive: Control line(C) and G line & M line appear in the test window.
IgM Positive: Two colored lines appear, one is in M area and the other is in Control area.
IgG Positive: Two colored lines appear, one is in G area and the other is in Control area.
Negative: Only one line appears in Control area, no line appears in G /M area.
Invalid: No line appears in the Control area, the test results are invalid regardless of the presence or absence of colored line in the test area. The cause of failure can be that the direction has not been followed correctly or the test materials may be deteriorated. It is recommended to redo the test using a new test cassette. If the problem persists, please stop using this test kit and contact our local distributor.

STORAGE AND STABILITY
Storage: store at 2~30°Ċ. Shelf life: 12 months.

LIMITATION OF THE TEST
This kit is a clinical auxiliary test product and cannot be the only test for diagnosis. The result of this kit should be further confirmed by other testing methods.

PERFORMANCE CHARACTERISTICS
1. Analytic Specificity
Results demonstrated that Coretests® COVID-19 IgM/IgG Ab Test has no significant cross-reactivity with the seromarkers listed below: influenza A virus, influenza B virus, hepatitis B surface antibody, hepatitis C virus, parainfluenza virus, human immunodeficiency virus, adenovirus, respiratory syncytial virus, EB virus, antinuclear antibodies, mumps virus, varicella zoster virus, enterovirus 71, measles virus, cytomegalovirus, mycoplasma pneumoniae and coronaviruses (229E, NL63, OC43 and HKU1).
2. Interference
The following substances and conditions were found to interfere with the test. List of potentially interfering compounds and concentrations tested are as follows: triglyceride
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(15mmol/L), hemoglobin (9g/L), bilirubin (250μmol/L), rheumatoid factor (80IU/mL) and human anti-mouse antibody (20ng/mL).
3. Diagnosis Sensitivity and Specificity
A clinical study using a total 300 blood samples was conducted. The results of the COVID-19 IgM/IgG Ab Test were compared with a nucleic acid detection test. The PPA and NPA of the IgM and IgG test results are given as below:

Table 1. Comparison of Coretests® Test and Nucleic Acid Test Results - IgM

IgM Positive percent agreement:90%(90/100), 95%CI:82.4%~95.1%

IgM Negative percent agreement:100%(200/200), 95%CI:98.2%~100%

IgM total agreement:96.7%(290/300), 95%CI:94.0%~98.4%

 

Table 2. Comparison of Coretests® Test and Nucleic Acid Test Results - IgG

IgG Positive percent agreement:91%(91/100), 95%CI:83.6%~95.8%

IgG Negative percent agreement:99%(198/200), 95%CI:96.4%~99.9%

IgG total agreement:96.3%(289/300), 95%CI:93.5%~98.2%

 

Table 3. Comparison of Coretests® Test and Nucleic Acid Test Results – IgM & IgG


IgM & IgG Positive percent agreement:95%(95/100), 95%CI:88.7%~98.4%

IgM & IgG Negative percent agreement:99%(198/200), 95%CI:96.4%~99.9%

IgM & IgG total agreement:97.7%(293/300), 95%CI:95.3%~99.1%

 

Manufactured by Core Technology Co., Ltd for Coretests Inc.
Coretests Inc.
6190 Yarrow Drive Carlsbad, CA 92011 USA
Core Technology Co., Ltd.
Room 100, C Building, No.29, Life Park Road Changping District, Beijing, 102206
China
PI-COVID19-01
Ver.1.1
Effective Date: May 2020