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The COVID-19 Rapid POC (Point-of-Care) kit is rapid test that qualitatively detects severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Using a rapid COVID-19 test provides an opportunity to identify more individuals who are unaware they have been infected.

How to use?

3 simple steps:

1
Add Sample

Add serum (10μl), plasma (10μl) or blood (10/20μl) to specimen well

2
Add Buffer

Add 2 drops of buffer (80μl) to specimen well

3
Read the results

Read the results after 10 mins

Interpretation of results:

IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.

IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgM line region.

IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the IgG region and IgM region.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. 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 colored line appearing in the control region (C) is an internal 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.

Biological Principle

The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to 2019-nCoV in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCoV. A colored line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM. A colored line appears in IgM test line region as a result.

Therefore, if the specimen contains 2019-nCoV IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains 2019-nCoV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain 2019-nCoV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Storage & Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Covid-19 Rapid Blood Kit B-nCoV

Testing Instructions:

Test should be carried out at room temperature 20-30C. Do not leave the specimens at room temperature for longer than 30 minutes before testing. Testing should be performed immediately after the specimens have been collected.

1: Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.

2: Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.

Puncture the skin with a sterile lancet. Wipe away the first sign of blood.

4: Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.

5: Add the Finger Whole Blood specimen to the test Cassette by using Dropper tube:

6: Add the Buffer Solution to the test cassette from the Buffer Solution tube

Check Results within 15 minutes (Results showed after 30 minutes have no significance)

 

Results:

POSTIVE (+)

COVID-2019 IgG Postive

2 Lines Appears: One line in region G and One line in region C

 

COVID-2019 IgM Postive

2 Lines Appears: One line in region M and One line in region C

 

COVID -2019 IgG & IgM Postive

3 Lines Appears: One line in region M, One line in region G and One line in region C

 

The positive results showed that the COVID-2019 antibody was present in samples.

 

NEGATIVE (-)

1 Lines Appears: One line in region C

 

The display window only shows the quality control line (C line). The negative results showed that the samples did not contain COVID-2019 ANTIBODY, or the content was lower than the detection of this product.

 

INVALID

COVID-2019 IgG Invalid

2 Lines Appears: One line in region G and One line in region M

 

COVID-2019 IgG Invalid

1 Lines Appears: One line in region G

 

COVID-2019 IgG Invalid

2 Lines Appears: One line in region M

 

COVID-2019 IgG Invalid

0 Lines Appears

 

The display window does not show the quality control (C line), indicating operation process is INVALID

Covid-19 Rapid Oral Kit 0-nCov

Testing Instructions:

Test should be carried out at room temperature 20-30C. Do not leave the specimens at room temperature for longer than 30 minutes before testing. Testing should be performed immediately after the specimens have been collected.

There are TWO ways to collect ANTIGEN in a human, The NASOPHARYNGEAL (Nasal Swab) and OROPHARYNGEAL (Throat Swab).

 

NASAL COLLECTION

  1. Inset the swab into the nasal cavity where secretions are most, Gently rotate and push the swab into the nasal cavity until the nasal turbinate is blocked (About 2 to 2.5 CM up the nostril), then press the swab against the nasal wall for three times and remove the swab.
  2. The swab sample then should be immediately placed into the TUBE that contains the virus sampling solution. Rotate the swab about 10 times to make the sample dissolve in the solution as much as possible.
  3. Use the Dropper to collect the sample from tube and drop into Cassette point (S).
  1. Check Results within 10-20 minutes (Results showed after 30 minutes have no significance)

 

THROAT COLLECTION

  1. Inset the swab completely from the mouth into the throat, centring on the red part of the throat wall and maxillary tonsils, rub the bilateral throat tonsils and throat wall moderately. Avoid toughing the tongue and remove the swab.
  2. The swab sample then should be immediately placed into the TUBE that contains the virus sampling solution, Rotate the swab about 10 times to make the sample dissolve in the solution as much as possible.
  3. Use the Dropper to collect the sample from tube and drop into Cassette point (S).
  1. Check Results within 10-20 minutes (Results showed after 30 minutes have no significance)

 

Results:

POSTIVE (+)

COVID-2019 IgG Postive

2 Lines Appears: One line in region T and One line in region C

The positive results showed that the COVID-2019 antibody was present in samples.

 

NEGATIVE (-)

1 Lines Appears: One line in region C

The display window only shows the quality control line (C line). The negative results showed that the samples did not contain COVID-2019 ANTIBODY, or the content was lower than the detection of this product.

 

INVALID

COVID-2019 IgG Invalid

1 Lines Appears: One line in region T

 

COVID-2019 IgG Invalid

0 Lines Appears

The display window does not show the quality control (C line), indicating operation process is INVALID

Materials provided

• Test cassettes
• Droppers
• Package Insert
• Buffer

Materials required but not provided

• Specimen collection containers
• Centrifuge (for plasma only)
• Lancets (for fingerstick whole blood only)
• Timer
• Capillary tubes
• Pipette

Disclaimer

While we believe this kit is to be an effective indicator of infection we cannot guarantee 100% accuracy so the patient should still be advised to follow government guidelines for those exhibiting symptoms and those who aren’t regarding hygiene, self-isolation and other measures even if the test is negative.

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