Covid-19 IgG/IgM Rapid Test

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· Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

· Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

· Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

Ideal Rehab Care is an Authorized Distributor of Healgen COVID-19 Test Kit.  Please be careful of groups/individuals who pose as a distributor of Healgen COVID-19 test kit without proper authorization

Additional Product Information

Test Results In Minutes.

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.

Fast results as soon as 2-10 minutes

Facilitates patient treatment decisions quickly

Simple, time-saving procedure

Little specimens, only 5 μL of serum/plasma or 10 μL of whole blood specimens

Create A Difference

With Rapid Covid-19 Test Kits, we can help people know if they are able to go back to work, as well as help researchers in tracking the scale and death rate of the disease which can lead to future aid in disease control and pandemic policy. 

As well as helping the average patient, these test kits will be used on public health officials creating a safe environment within the medical field knowing that they have a certain immunity to the Coronavirus.

How To Use

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.

2. Lay the device on a flat surface and add specimen (see specific instructions for each specimen type below):

a. For Serum or Plasma Specimen: With the 5 μL plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

b. For Whole Blood Specimen (Finger Stick / Venous):  Prior to taking a finger stick sample, clean fingertip with an alcohol wipe before using a lancet. Puncture the fingertip, wipe away the first drop of blood and collect the second drop. Hold the 5 μL plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).

4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Features

  • Detection Window (IgM): 3-5 days after incubation 

  • Dual band results for simple interpretation

  • Multivariable analysis of immunoglobin IgG & IgM

  • Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)

  • Procedural internal control included

  • Buffer included

Specifications

  • Sensitivity: IgG 97.2%; IgM 87.9%

  • Specificity: IgG 100%; IgM 100%

  • Specimen: Whole Blood, Serum, Plasma

  • Time to Results: 10 minutes

  • Shelf Life: 24 months from the date of manufacture

Ordering Information

Item Code

Description

Format

Specimen

UOM

GCCOV-402a (CE)

COVID-19 IgG/IgM Rapid Test

Cassette

Whole Blood / Serum / Plasma

25 Tests / Kit

This product is intended for professional use and not for home use. Results from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

A negative result may appear and not correlate with symptoms.  A medical professional is required to consider various factors, including confirmation testing, when receiving a presumptive result.

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