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. 

Performance evaluation

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.

Performance evaluation

Interference

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:

Notification

• 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