INSTANT-VIEW® PLUS COVID-19 ANTIGEN RAPID TEST

For patients with suspected COVID-19 infection.

  • Result in 3~7 minuts
  • No additional instruments or intervenes or laboratory required
  • Sensitivity of 92% and specificity of 100%
  • CE-Marking
  • Application within Point of Care (POC) setting
HOW IT WORKS

USAGE

The Instant-View® COVID-19 Antigen Rapid Test in 6 easy steps

1

Step 1

Remove white cap and discard.

2

Step 2

Insert swab, swirl 3 times and let set for 1 minute.

3

Step 3

Squeeze liquid from swab head inside tube while removing swab, close tip and push down to seal.

4

Step 4

Remove device from pouch, set on flat surface and add 2 drops into sample well.

5

Step 5

Wait until the burgundy color flow appears in the Result Window before closing the cap. Push cap closed and set timer between 3-7 minutes.

6

Step 6

Read results after 3 – 7 minutes.

INFORMATION

Driven Flow® Technology

Driven Flow® Technology is a true one-step, three minute test with high accuracy.  It is attainable through a tightly restricted sample flow-path with additional flow acceleration, and both forward and downward pressures.  These pressures add a strong self-washing function during the flow process, resulting in minimization of non-specific binding in the reaction area.  Only the specifically bound antibody-antigen complex remains on the Test line/s through the self-wash process.

Driven Flow® Technology can drastically reduce reaction times, improve the accuracy of the assay, and increase confidence in the specificity of the test.

Product Features

Results in 3-7 minutes

Time and cost savings

Readable for 24 Hours

Long reading window, so more flexibility in the (reading) logistics

Small sample size

Eliminates insufficient sampling issues

Two-step process

Easy-to-use with less potential for procedural errors

Sealed test cassette

Easy to use

Internal controls included

Confidence in results due to confirmation of test strip functional integrity

Room temperature storage

No need for refrigeration or wait times for reagents to warm up. Tests can be run immediately as needed.

Product Specifications

Sample type

Nasopharyngeal

Detects

Nucleocapsid protein antigen from SARS-CoV-2

Time to results

3-7 minutes

Kit storage conditions

Room temperature (2°C to 30°C/39°F to 86°F)

Internal controls

Included

Shelf life

Minimum of 18 months from date of manufacture

Product Intended Use

The Instant-View® COVID-19 Antigen Rapid Test is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swabs from individuals meeting the clinical and / or epidemiological criteria for COVID -19.

The Instant-View® COVID-19 Antigen Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product can be used in laboratories and in any other environment that meets the requirements specified in the instructions for use and local regulations. The test provides preliminary test results. Negative results do not preclude infection with SARS-CoV-2 and cannot be used as the sole starting point for treatment or other decision making. Negative results should be combined with clinical observations, patient history and epidemiological information. The test is not intended to be used as a donor screening test for SARS-CoV-2.

Product Documents

Manual – Instant-View® COVID-19 Antigen Rapid Test

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Prescription – Instant-View® COVID-19 Antigen Rapid Test

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