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Qualitative test for COVID-19 total Ab

The FREND™ COVID-19 total Ab is a fluorescence immunoassay (FIA) which can be used to aid in identifying individuals with an adaptive immune response to SARS-CoV-2 using human plasma.

KEY FEATURES & BENEFITS

- U.S. FDA EUA approved

- 3 minutes | Fast result
- 2 steps | Easy to use
- 96.7% & 98.8% | Positive & Negative Percent Agreement

- Microfluidic Qualitative Immunoassay

- LIS connectivity (data management)

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FAQ

Microfluidic Qualitative Immunoassay

FREND™ COVID-19 total Ab

The FREND™ COVID-19 total Ab is a fluorescence immunoassay (FIA) which can be used to check whether patient has developed immune response to SARS-CoV-2 using human plasma. For COVID-19 total Ab, its detection is based on a fluorescent immunoassay showing qualitative result.

Instructions for use

Accurate result in 3 minutes!

With just simple steps of operation, the FREND™ system supports quick decision-making.

Performance evaluation

Cross-reactivity

The cross-reactivity testing was performed on samples collected prior to COVID-19 outbreak from the United States of America.

Performance evaluation

Clinical agreement study

The total of 91 clinical samples (75 positive and 16 negative) confirmed with RT-PCR were tested with the FREND™ COVID-19 total Ab. It shows 96.0% PPA (Positive Percent Agreement) and 93.8% NPA (Negative Percent Agreement) as shown below.

An additional 56 clinical samples (44 SARS-CoV-2 PCR confirmed and 12 negative, pre-COVID-19) were tested with the FREND™ COVID-19 total Ab. The results are presented in the table below.

An additional 200 clinical samples (100 SARS-CoV-2 PCR confirmed and 100 negative, pre-COVID-19) were tested with the FREND™ COVID-19 total Ab. The results are presented in the table below.

The results of the total 347 clinical samples (219 RT-PCR confirmed positive SARS-CoV-2 and 128 negative, pre-COVID-19) are presented in the table below.

Independent Clinical Agreement Validation

The FREND COVID-19 total Ab from NanoEntek was tested on August 19, 2020 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI).

Performance evaluation

Interference

The interference evaluation test of FREND™ COVID-19 total Ab was conducted according to CLSI Guidelines EP7-A2 using one lot. No interference in the testing of the FREND™ COVID-19 total Ab 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

• 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.

Assay method

Fluorescent immunoassay
Cat. No.

FRCOA 020
Specimen

EDTA Plasma
Volume

35 μL
Time to result

Cartridge reaction : < 3 min
Package

20 tests
Storage condition

2–8 °C (35–46 °F)

FREND™ COVID-19 total Ab Tutorial Video

FREND™ COVID-19 total Ab Tutorial Video
COVID-19 Product line up Introduction Video

COVID-19 Product line up Introduction Video

Related downloads Total 2

FREND_COVID-19_total_Ab_Brochure_NanoEntek
COVID-19_total Ab_IFU_NanoEntek

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