Name: INSTI Covid-19 IgG/IgM Antibody Test
SKU: INSTI-AB
Price: 8.00 CAD
Availability: OutOfStock

Product Code: 90-1092
Sample: Whole Blood / Serum / Plasma
Format: Cassette
Quantity: 1 Tests/Box
Time to result: 1 minute
Storage Condition: 2°C to 30°C (35.6° to 86°F)
Expiration: May 7, 2023
Test Principle: Immunochromatographic Lateral Flow Assay

The INSTI® COVID-19 rapid test kit is a single-use, visually read, rapid, flow-through in-vitro qualitative immunoassay intended for the detection of total antibodies (IgM/IgG) to SARS-CoV-2 in human venipuncture whole blood, serum and plasma.

The INSTI® COVID-19 Antibody Test is intended for use as an aid in identifying an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Results are available in as little as 60 seconds and should be read and interpreted within 20 minutes.

INSTI® is trusted by healthcare professionals globally with over 15 million tests already performed. The INSTI platform provides accurate results in 1 minute, where other competing products require 20 minutes to days for their results.

Clinical Evaluation Data

Clinical evaluation data for venous whole blood and serum samples:

> 98.2% Sensitivity and 99.6% Specificity

Weight	0.05 lbs

Test Technology	IgG/IgM (qualitative)
Diagnostic Sensitivity	98.2%
Diagnostic Specificity	99.6%
Shelf Life (expiration)	May 7, 2023
Storage Temperature	2-30°C/36-86°F
Time to Result	1 minute
Sample Collection	Blood

Instructions

Intended Use

Not for donor screening

The INSTI COVID-19 Antibody Test is a single use, visually read, rapid, flow-through in vitro qualitative immunoassay for the detection of total antibodies to SARS-CoV-2 in human whole blood, serum and plasma (EDTA, sodium heparin, sodium citrate) intended for use by Health care professionals. The INSTI® COVID-19 Antibody Test is not intended for use in screening blood, plasma, or tissue donors. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.