Zika Rapid Tests CE Marking


Biopanda Reagents offers tests for both the Zika NS1 antigen, and Zika IgG/IgM antibodies.

Zika NS1 Rapid Test

Product Number: RAPG-ZIKA-001

Pack size

20 tests

Product Description

The Biopanda Zika NS1 Rapid Test is a rapid immunochromatographic assay for the qualitative detection of NS1 antigen of Zika virus in human whole blood, serum, or plasma to assist in the diagnosis of Zika infections.

Test Attributes

  • Whole blood, serum, or plasma may be used for testing
  • Results available in only 15 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose Zika infections

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing.
  2. Open the foil wrapped pouch and remove the cassette. Place on a flat, clean surface.
  3. Holding the pipette vertically add the recommended amount of whole blood,  serum or plasma sample into each sample well.
  4. Results should be read at 15 minutes.
  5. Results read after 20 minutes are considered invalid. Dispose of the cassette safely after testing.
Buffer drawing

Principle

The Biopand Zika NS1 Rapid Test is a qualitative membrane-based immunoassay for the detection of Zika NS1 antigen in whole blood, serum, or plasma. During testing, the specimen reacts with Zika NS1 antibody-conjugate in the test cassette. The Gold antibody conjugate will bind to Zika NS1 antigen in the specimen sample which in turn will bind with Anti-Zika NS1 coated on the membrane. As the reagent moves across the membrane, the Zika NS1 antibody on the membrane will bind the antibody-antigen complex causing a dark red or pink line to form at the test line region of the test membrane. The intensity of the lines will vary depending upon the amount of antigen present in the sample. The appearance of pink line in the test region should be considered as positive result.

 

Performance Characteristics

  • Relative sensitivity: 80.0%
  • Relative specificity: 94.0%
  • Accuracy: 91.7%

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.

Zika IgG/IgM Rapid Test

Product Number: RAPG-ZIKA-002

Pack size

20 tests

Product Description

The Biopanda Zika IgG/IgM Rapid Test is a rapid immunochromatographic assay for the qualitative detection of IgG and IgM antibodies to Zika virus in human whole blood, serum, or plasma to assist in the diagnosis of Zika infections.

Test Attributes

  • Whole blood, serum, or plasma may be used for testing
  • Results available in only 15 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose Zika infections

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing.
  2. Open the foil wrapped pouch and remove the cassette. Place on a flat, clean surface.
  3. Holding the pipette vertically add the recommended amount of whole blood,  serum or plasma sample into each sample well.
  4. Results should be read at 15 minutes.
  5. Results read after 20 minutes are considered invalid. Dispose of the cassette safely after testing.
Zika IgGIgM

Principle

The Biopanda Zika IgG/IgM Rapid Test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in the IgG test line region. During testing, the specimen reacts with Zika NS1 antigen-coated particles in the test cassette. The mixture then migrates laterally on the membrane chromatographically by capillary action and reacts with the anti-human IgG in the IgG test line region. If the specimen contains IgG antibodies to Zika, a coloured line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in the IgM test line region. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM antibodies to Zika virus, the conjugate-specimen complex reacts with anti-human IgM. A coloured line appears in IgM test line region as a result.
Therefore, if the specimen contains Zika IgG antibodies, a coloured line will appear in the IgG test line region. If the specimen contains Zika IgM antibodies, a coloured line will appear in the IgM test line region. If the specimen does not contain Zika antibodies, no coloured line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, to show the test has been performed properly.

Performance Characteristics

Test Sensitivity Specificity Accuracy
IgG >99.9% 98.9% 99.1%
IgM 94.4% >99.9% 99.0%

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.

Zika Combo Rapid Test

Product Number: RAPG-ZIKA-003

Pack size

10 tests

Product Description

The Biopanda Zika Combo Rapid Test qualitatively detects NS1 antigen, IgG and IgM antibodies of Zika virus in human whole blood, serum or plasma samples. This test applies lateral flow immunochromatography and is a tool to assist in the diagnosis of Zika infections.

Test Attributes

  • Whole blood, serum, or plasma may be used for testing
  • Results available in only 15 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose Zika infections

Test Procedure

  1. Ensure specimen and test kits are brought to room temperature before testing.
  2. Open the foil wrapped pouch and remove the cassette. Place on a flat, clean surface.
  3. Holding the pipette vertically add the recommended amount of whole blood,  serum or plasma sample into each sample well.
  4. Results should be read at 15 minutes.
  5. Results read after 20 minutes are considered invalid. Dispose of the cassette safely after testing.
Zika combo cassette

Principle

The Zika IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to Zika Virus 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 Zika NS1 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 the IgG test line region, if the specimen contains IgG antibody to Zika virus. A coloured 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 antibody to Zika virus, the conjugate-specimen complex reacts with anti-human IgM. A coloured line appears in the IgM test line region as a result.
Therefore, if the specimen contains Zika IgG antibody, a coloured line will appear in the IgG test line region. If the specimen contains Zika IgM antibody, a coloured line will appear in the IgM test line region. If the specimen does not contain Zika antibodies, no coloured line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

The Zika NS1 Rapid Test is a qualitative membrane-based immunoassay for the detection of Zika NS1 antigen in whole blood, serum, or plasma. During testing, the specimen reacts with Zika NS1 antibody-conjugate in the test cassette. The Gold antibody conjugate will bind to Zika NS1 antigen in the specimen sample which in turn will bind with anti-Zika NS1 coated on the membrane. As the reagent moves across the membrane, the anti-Zika NS1 on the membrane will bind the antibody-antigen complex causing a dark red or pink line to form in the test line region of the test membrane. The intensity of the line will vary depending upon the amount of antigen present in the sample. The appearance of pink line in the test region should be considered as positive result.

Performance Characteristics

Test Sensitivity Specificity Accuracy
IgG >99.9% 98.9% 99.1%
IgM 94.4% >99.9% 99.0%
NS1 80.0% 94.0% 91.7%

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.

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