Rapid diagnostic test for COVID-19 IgM/IgG A006019 (50 kits)

The COVID-19 lgG / lgM rapid diagnostic test (Blood / serum / plasma) is a rapid immunochromatographic test for the quick, qualitative, and differential detection of lgG and lgM antibodies against the new coronavirus 2019 in whole blood, serum, or human plasma. For exclusive use by qualified and properly trained professionals.

The expiration date of these tests is 03/12/2020.

IMPORTANT NOTE: According to notification from AEMPS, RD 21/2020 has been published, which annuls the Ministerial Orders approved under the state of alarm, including Order SND/344/2020, of April 13. Consequently, MEDICAL PRESCRIPTION IS NO LONGER REQUIRED for the sale of this product.

BOX OF 50 TESTS Includes:
50 Rapid tests (Cassette + 2 Buffers)
50 Safety lancets
50 Antiseptic wipes
1 Bottle
1 Instructions for use and leaflet

FEATURES

This test only provides a preliminary test result. Therefore, any reactive sample with the COVID-19 IgG/IgM rapid test cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing methods and clinical findings.

INSTRUCTIONAL VIDEO

WARNINGS AND PRECAUTIONS

1. The test is for single use only. It should not be reused under any circumstances.
2. For professional in vitro diagnostic use only. Do not use after the expiration date.
3. Read the instructions for use before performing the test to avoid obtaining inaccurate test results.
4. Handle all samples as if they contain infectious agents. Observe established precautions against microbiological risks during testing and follow standard procedures for the proper disposal of samples.
5. Wear protective clothing such as lab coats, disposable gloves, and eye protection when analyzing samples.
6. Humidity and temperature can negatively affect results.
7. Do not perform the test in a room with strong airflow, i.e., strong electric fan or air conditioning.

PRINCIPLES AND COMPONENTS

The COVID-19 IgG/IgM rapid test cassette (Whole Blood/Serum/Plasma) is a lateral flow immunoassay. The test uses human IgM antibodies (IgM test line), human IgG antibodies (IgG test line), and goat anti-rabbit IgG (control line C) immobilized on a nitrocellulose strip.

The burgundy conjugate pad contains colloidal gold conjugated with recombinant COVID-19 antigens conjugated with colloidal gold (COVID-19 conjugates) and rabbit IgG-gold conjugates.

When a specimen followed by test buffer is added to the sample well, the IgM and/or IgG antibodies, if present, will bind to the COVID-19 conjugates forming antigen-antibody complexes. This complex migrates through the nitrocellulose membrane by capillary action.

When the complex encounters the corresponding immobilized antibody line (human IgM and/or human IgG), the complex is trapped forming a burgundy band that confirms a reactive test result. The absence of a colored band in the test region indicates a non-reactive test result.

To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicating that the appropriate sample volume has been added and membrane absorption has occurred.

SUPPLIED MATERIAL

• 50 sealed bags, each containing a test cassette, a dropper, and a desiccant
• 1 buffer
• 1 instructions for use

MATERIAL REQUIRED BUT NOT SUPPLIED

• Sample collection containers
• Lancets (for whole blood only with fingerstick)
• Centrifuge (for plasma only).
• Timer
• Heparinized capillary tubes and dispensing bulb (for whole blood fingerstick only)

STORAGE CONDITIONS

The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable until the expiration date printed on the sealed bag. The test device must remain in the sealed bag until use. Do not freeze. Do not use beyond the expiration date.

SAMPLE COLLECTION AND PREPARATION

1. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood, serum, or plasma.

2. Separate the serum or plasma from the blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed samples.

3. Tests should be performed immediately after sample collection. Do not leave samples at room temperature for prolonged periods. Serum and plasma samples can be stored at 2-8°C for up to 3 days. For long-term storage, samples should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test will be performed within 2 days of collection. Do not freeze whole blood samples. Whole blood collected by fingerstick should be analyzed immediately.

4. Allow samples to reach room temperature before testing. Frozen samples must be completely thawed and mixed well before testing. Samples cannot be frozen and thawed repeatedly.

5. If samples are to be sent, they must be packed according to local regulations covering the transport of etiological agents.

VISUAL PROCEDURE SCHEME

Allow the test cassette, sample, buffer, and/or controls to equilibrate to room temperature (15-30 °C) before testing.

1. Remove the test cassette from the sealed aluminum bag and use it as soon as possible. Better results will be obtained if the assay is performed within one hour.

2. Place the test device on a clean, level surface.
For Serum or Plasma Samples:
Using the provided 5 μL plastic mini dropper, draw a serum/plasma sample to exceed the sample line as shown in the following image, and then transfer the extracted serum/plasma sample to the sample well (S). Then add 2 drops (approximately 80μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

Note: Practice a few times before the test if you are not familiar with the mini dropper. For better accuracy, transfer the sample with a pipette capable of delivering 5 μL of volume.

For Whole Blood Samples:
Hold the 5 μL plastic mini dropper vertically and transfer 1 drop of whole blood (approximately 10 μL) to the sample well (S) of the test device, then add 2 drops (approximately 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

3. Wait for the colored lines to appear. After 2 minutes, if the red color has not moved across the test window or if there is still blood in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).

4. The result should be read in 10 minutes. Positive results may be visible as early as 2 minutes. Do not interpret the result after 15 minutes.

RESULTS INTERPRETATION

NEGATIVE: The colored line in the control line region (C) changes from blue to red. No line appears in the M or G test line regions. The result is negative.

IgM POSITIVE: The colored line in the control line region (C) changes from blue to red, and a colored line appears in the M test line region. The result is anti-COVID-19 IgM positive.

IgG POSITIVE: The colored line in the control line region (C) changes from blue to red, and a colored line appears in the G test line region. The result is anti-COVID-19 IgG positive.

IgG and IgM POSITIVE: The colored line in the control line region (C) changes from blue to red, and two colored lines appear in the M and G test line regions. The result is anti-COVID-19 IgM and IgG positive.

INVALID: The control line is still completely or partially blue and cannot change completely from blue to red. An insufficient sample volume or incorrect procedural techniques are the most likely reasons for the failure of the control line. Review the procedure and repeat the test with a new test cassette. If the problem persists, stop using the test kit immediately and contact your local distributor.

QUALITY CONTROL

A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient sample 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 good laboratory practice to confirm the testing procedure and verify the proper performance of the test.

LIMITATIONS OF THE PROCEDURE

1. Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particles that may block the membrane. This slows the flow of reagents and may result in elevated background color, making interpretation of results difficult.
2. Optimal assay performance requires strict adherence to the testing procedure described in this insert. Deviations may lead to aberrant results.
3. A negative result for an individual subject indicates the absence of detectable anti-COVID-19 antibodies. However, a negative result does not exclude the possibility of exposure or infection with COVID-19.
4. A negative result may occur if the amount of anti-COVID-19 antibodies present in the sample is below the assay's detection limits, or if the antibodies being detected are not present during the stage of the disease at which the sample was collected.
5. Some samples containing an unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
6. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by a physician after all clinical and laboratory findings have been evaluated.

CLINICAL PERFORMANCE

The COVID-19 IgG/IgM Rapid Test has been evaluated with 113 blood samples obtained from patients presenting pneumonia or respiratory symptoms. The results were compared with RT-PCR or clinical diagnosis (including Chest CT and clinical signs, etc.) of "Diagnosis and treatment of the new coronavirus pneumonia."

Regarding the IgM test, the comparison of results with RT-PCR.

Regarding the IgG test, we counted the positive rate of 36 out of 113 patients during the convalescence period.

The sensitivity of the IgM test is 87.9% (87/99) and the specificity is 100% (14/14) compared to RT-PCR.

The sensitivity of the IgG test is 97.2% (35/36) during the convalescence period, and the specificity is 100% (14/14).

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