Ezmedtest Covid-19 IgGIgM Rapid Test

Ezmedtest Covid-19 IgGIgM Rapid Test

Antibody Detection Kit

 

PRODUCT NAME

General Name:Ezmedtest Covid-19 IgGIgM Rapid Test (colloidal gold)

SPECIFICATIONS

  1. Quantity: 02 Tests/ Kit
  2. Sensitivity: 92%, Specificity: 97.3%.
  3. Sample: Whole or peripheral blood or Serum and Plasma
  4. Detection Method: Colloidal Gold
  5. Detection Time: 15 minutes

INTENDED USE

  • This kit is a qualitative in vitro diagnostic kit for the detection of new coronavirus (2019-nCoV) IgM / IgG antibodies in human serum. This colloidal gold-based kit is only a complement coronavirus diagnostic approach to nucleic acid detection, it can be applied to the suspected cases, which is not yet tested or tested negative via the nucleic acid detection. The tested results of this colloidal gold-based kit cannot be used as the decisive evidence to eliminate the possible infection of the coronavirus and its related pneumonia.
  • All positive test results require further confirmation. Negative test results do not eliminate the possibility of the infection.
  • This kit cannot be used as a conventional clinical in vitro diagnostic kit. All the test results are for clinical reference only; a comprehensive diagnosis is suggested to be carried out based on the clinical performance of the patient and additional laboratory tests.
  • Laboratory works regarding the coronavirus detection must strictly follow the rules in the “Laboratory Guidelines for testing the infection of the new coronavirus”etc. All processes associated with biosafety must be carried out accordingly.

PRINCIPLE

  • This product detects the new coronavirus IgM and IgG antibodies based on the principle of immunocapture. The nitrocellulose membrane was coated with mouse anti-human IgM (μ chain) monoclonal antibody, mouse anti-human IgG (γ chain) monoclonal antibody, and goat anti-mouse IgG antibody, respectively. The signal tracer is a mixture of colloidal gold-labeled recombinant new coronavirus (nCoV) antigen and colloidal-labeled mouse IgG antibodies. Sample was initially applied to the sample well of the nCoV IgG/IgM testing cassette, if a sample contained anti-nCoV IgM antibodies, these IgM antibodies would be captured by the gold-labeled recombinant nCoV antigens and formed complexes. Subsequently, these complexes would be captured by the mouse anti-human IgM (μ chain) coated on the nitrocellulose membrane and a purple-red band would appear on the membrane.
  • If a sample contained anti-nCoV IgG antibodies, these antibodies would be captured by the gold-labeled recombinant nCoV antigens and formed complexes. These complexes would be further captured by the mouse anti-human IgG (γ chain) coated on the nitrocellulose membrane and a purple-rad band would appear on the membrane. The control lane is where the goat anti-mouse IgG coated on the nitrocellulose membrane and the gold-labeled mouse IgG would form complexes with the goat anti-mouse IgG to show a purple-rad lane.

 SARS-CoV-2 (Covid-19): Diagnosis by IgG/IgM Rapid Test

Assay procedure: Capillary blood is used to do the test, prick the finger and collect the blood by a capillary tube. And then, load the blood onto the sample well (S) of the test device.

IgM and IgG are immunoglobulins produced by the immune system to provide protection against SARS-CoV-2. Anti-SARS-CoV-2 IgM and IgG can therefore be detected in samples from affected patients.

The level of IgM antibody begins to rise after 1 week after the initial infection, while the IgG appears later than IgM (usually in 14 days after infection) and can last for 6 months or even several years, which means that the IgG serves as an indicator of previous infection. Suspected patients that are infected by SARS-CoV-2 can be rapidly identified by simultaneous monitoring of IgM and IgG. During the outbreak period of 2003-SARS and the 2016-Zika, IgM/IgG antibody detection was used as one of the recommended diagnostic methods.

A sample can be positive if there are IgM, IgG, or both IgM and IgG antibodies present.

There are different cassettes for the rapid tests. In general, for the qualitative detection of IgG and IgM in the same time, there are 3 different lines : one for IgG (G line) , one for IgM (M line) and one for the control (C line).

INTERPRETATION OF TEST RESULTS

Read and record the results within 15 minutes.

  1. 2019-nCoV IgM positive: A clear magenta band appears at the position of the IgM testing lane as well as the control lane, this suggests the sample is positive for 2019-nCoV IgM antibodies.
  2. 2019-nCoV IgG positive:A clear magenta band appears at the position of the IgG testing lane as well as the control lane, this suggests the sample is positive for 2019-nCoV IgG antibodies.
  3. 2019-nCoV negative:A clear magenta band only appears at the position of the control lane, no visible band appears at the position of IgM testing lane and IgG testing lane, this suggest the sample is negative for 2019-nCoV.
  4. Invalid:There is no visible band at the position of the control lane. The result is invalid regardless of bands appear at the position of the testing lanes.
  5. Result validated time:The result is validated within 15 minutes once the sample was added to the sample well, any band appears after 15 minutes is invalid.

To be validated, this test have to present a positive line for control (C)

Results

Interpretation

IgM+ / IgG+ Recent infection with SARS-CoV-2
IgM+ / IgG- Recent infection with SARS-CoV-2
IgM- / IgG+ Previous infection with SARS-CoV-2
IgM- / IgG- No infection or not enough detectable antibodies in the early infection

MAIN COMPONENTS

  1. Testing cassette. The testing cassette consists of a plastic board, a nitrocellulose membrane, an absorbent paper, a whole blood filter membrane, a sample pad and a gold-bearing pad; it contains a recombinant new coronavirus antigen, a mouse anti-human IgM (μ chain) monoclonal antibody, and a mouse Human IgG (γ chain) monoclonal antibody, mouse IgG antibody and goat anti-mouse IgG antibody.
  2. Sample diluent: 20mM phosphate buffered saline (PBS), casein sodium salt, PC300; 4mL × 1 bottle (25T).
  3. Sample pipette.
  4. Lancet

STORAGE & VALIDITY

  1. Store at 4~30℃, the validity period is tentatively set for 12 months.
  2. Perform the test under 60% humidity within 1 hour after opening the bag.
  3. Production date and expiration date are on label.

SPECIMEN

  1. Serum is collected via conventional approaches. Avoid hemolysis.
  2. Collected serum samples can be stored for 3 days at 2°C to 8°C; the tentative storage period for serum samples stored at ≤-20 °C is 2 months; Samples cannot be repeated frozen and thawed; the optimum sample for testing is a freshly collected sample.
  3. Attention should be paid to aseptic operations during the process of sample collection and storage.

PROCEDURE

  1. Open the aluminum foil bag and take out the testing cassette.
  2. 10 μL of a serum (or plasma) sample was added to the sample well of the 2019 nCoV IgM/ IgG testing cassette, then 2 drops of the sample diluent was immediately added to the sample well. The cassette was incubated for 15mins at room temperature and test result was observed within 15mins.

INTERPRETATION OF TEST RESULTS

Read and record the results within 15 minutes.

  1. 2019-nCoV IgM positive: A clear magenta band appears at the position of the IgM testing lane as well as the control lane, this suggests the sample is positive for 2019-nCoV IgM antibodies.
  2. 2019-nCoV IgG positive: A clear magenta band appears at the position of the IgG testing lane as well as the control lane, this suggests the sample is positive for 2019-nCoV IgG antibodies.
  3. 2019-nCoV negative: A clear magenta band only appears at the position of the control lane, no visible band appears at the position of IgM testing lane and IgG testing lane, this suggest the sample is negative for 2019-nCoV.
  4. Invalid: There is no visible band at the position of the control lane. The result is invalid regardless of bands appear at the position of the testing lanes.
  5. Result validated time: The result is validated within 15 minutes once the sample was added to the sample well, any band appears after 15 minutes is invalid.

LIMITATIONS OF INSPECTION METHODS

  1. This product is a complementary kit for the diagnosis of 2019-nCoV and all the results are qualitative, all results need to be confirmed by nucleic acid test and further analyzed based on other clinical test results and the clinical performances of the patients. This kit should not be used for normal people scanning.
  2. In the early stage of the infection, the absence or low titers of IgM and IgG antibodies against new coronaviruses will result in negative results, such results should be re-examined within 7-14 days. To confirm the presence of serological positive or a significant enhancement of antibody titer, a parallel set of tests needs to be done during the re-examination for the serum samples collected earlier from the patients.
  3. The referencing value of this serological test results for those patients who has impaired immunity or is receiving immunosuppressive therapy is limited.
  4. IgM antibody positive occurs not only in the primary infection, but also in the secondary infection.
  5. IgG positive suggests the patient is either being infected previously or is currently undergoing a secondary infection.
  6. Clinical performance of the patient or additional diagnostic approaches are necessary for confirming the infection of the new coronavirus.
  7. The test sensitivity and specificity may vary between different populations due to the difference in geography, race, sex and age. It is recommended to perform clinical verification before testing on patients.

PRODUCT PERFORMANCE

  1. Appearance: The package is intact, aluminum bag is well sealed, all the labels, manuals are clear, sample diluent is clear, no contaminant, no sediment.
  2. Membrane width: Membrane width should not exceed 3.0mm.
  3. Flow rate:Flow rate should not slower than 10mm/min.
  4. Accuracy
  • Accuracy of the kit is verified using national reference samples or standardized enterprise reference samples.
  • Test accuracy using enterprise reference sample
  • Match rate of the positive enterprise references should be 5/5. Match rate of the negative enterprise references should be 8/8.
  1. Lowest detection limit: LOD of the kit is verified using national reference samples or standardized enterprise reference samples.The test results of the enterprise LOD sample (L) should be positive.
  2. Reproducibility
  • Reproducibility of the kit is verified using standardized enterprise reference samples.
  • The enterprise reference sample is tested for 10 times by the kit, all the results should be positive and show homogeneous color.

PRECAUTIONS

  1. Try use fresh samples and avoid samples that are contaminated, hemolyzed, jaundice, or hyperlipidemia. Avoid testing germ contaminated, haemolyzed, high jaundice and high blood fat samples.
  2. Any result obtained by this kit is invalid if the testing period is longer than 15mins.
  3. The product is for professional use.

SYMBOLS USED