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- Medical Devices
14 NanoEnTek Inc.
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|Product name||FREND COVID19 SP||Certification||-|
|Keyword||corona virus , poct , spike protein , covid test||Unit Size||-|
|Brand name||-||Unit Weigh||-|
|Supply type||-||HS code||-|
Microfluidic Qualitative Immunoassay
FREND™ COVID-19 SP (Spike Protein)
The FREND™ COVID-19 SP is
- a point-of-care testing (POCT) which can be used to check whether patient has developed immune
response to SARS-CoV-2 using human serum or plasma.
- a fluorescence immunoassay (FIA) using the FREND™ System intended for the
qualitative detection of IgG and IgM antibodies to SARS-CoV-2.
- is intended for use as an aid in identifying individuals with an adaptive immune response
to SARS-CoV-2, indicating recent or prior infection.
KEY FEATURES & BENEFITS
- 3 minutes | Fast result
- 2 steps | Easy to use
- 97% & 96% | Positive & Negative Percent Agreement
- Microfluidic Qualitative Immunoassay (spike protein)
- LIS connectivity (data management)
Instructions for use
Accurate result in 3 minutes!
With just simple steps of operation, the FREND™ system supports quick decision-making.
Clinical agreement study
The total of 88 clinical samples (34 positive and 54 negative) confirmed with RT-PCR were tested
with the FREND™ COVID-19 SP. It shows 97.06% PPA (Positive Percent Agreement) and 96.30% NPA
(Negative Percent Agreement) as shown below.
The interference evaluation test of FREND™ COVID-19 SP was conducted according to CLSI Guidelines EP7-A2 using one lot.
No interference in the testing of the FREND™ COVID-19 SP with 4 interfering substances was observed.
Effective Data Management
Laboratory Information System Connectivity
In the event of a pandemic, the management of a vast amount of clinical result is important.
However, many laboratories face the challenge in arranging the essential information effectively(1).
The FREND™ System which is LIS compatible provide following features:
• This test has not been reviewed by the FDA.
• 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.
• Not for the screening of donated blood.
For more information, please visit www.nanoentek.com
|Payment Options||Negotiable||Shipping time||Negotiable|
14 NanoEnTek Inc.
Guro-gu, Guro-dong,235-2, Guro-gu, Seoul, Korea
No. of Total Employees
- U. Kingdom
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