Product Manual

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LIMITATIONS

The Flowflex COVID-19 Antigen Home Test is for in vitro diagnostic use only. The test should be used for

the detection of SARS-CoV-2 antigens in anterior nasal swab specimens only. The intensity of the te

line does not necessarily

correlate to SARS-CoV-2 viral titer i

n the specimen.

Specimens should be tested as quickly as possible after specimen collection.

3. Failure to follow the instructions for use may adversely affect test performance and/or invalidate the test result.

4. A false negative result may occur if the level of antigen in a sample is below the detection limit of the test.

A false negative result may occur if the sample was collected incorrectly or handled.

A false negative result may occur if the swab is not swirled at least 30 seconds or rota

ted five times

A false negative or invalid result may occur if less than 4 drops of fluid are added to the Sample W

ell.

8. A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes

This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test performan

depends

on the amount of virus (antigen) in the sample and may or may not correlate with viral culture

results performed on the same sam

ple.

. The Flowflex COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2.

11.

Test results should be correlated with other clinical data available to the phys

ician.

12.

A positive or negative test result does not rule out co-infections with other pathogens such as other v

iral

or bacterial infections.

13.

Negative results are presumptive, do not rule out COVID-19 infection and it may be necessary to obtain

additional testing with a molecular assay, if needed for patient management.

14.

A negative test result is not intended to rule out other viral or bacterial infections.

15. If the differentiation of specific SARS viruses and strains is needed, additional testing is required, in

consultation with state or local public health departments, is required. The performance of this test w

established based on the evaluation of a limited number of clinical specimens collect

ed between Marc

and Ma

y 2021. Clinical performance has not been established with all circulat

ing variants but is

anticipated to be

reflective of the prevalent variants in circulation at t

he time and location of the clinical

evaluation. Perfo

rmance at the time of testing may vary depending on the variants circ

ulating, including

wly emerging strains of SARS-CoV-2 and their prevalence, which change over ti

me.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The performance of Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study

conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by

another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of

COVID-19 and 64 asymptomatic patients. All subjects were screened for the presence or absence of COVID-

19 symptoms within two weeks of study enrollment. The study was conducted in a simulated home setting

environment at two study sites in U.S. All study participants performed the test unassisted and interpreted the

result, using only the product labeling. The Flowflex COVID-19 Antigen Home Test results were compared to

an FDA EUA RT-PCR COVID-19 assay to determine test performance in the tables below:

Table 1. Performance of Flowflex COVID-19 Antigen Home Test in ALL subjects

Flowflex COVID-19 Antigen Home Test

RT-PCR method

Positive Negative Total

Positive 39 0 39

Negative 3 130 133

Total 42 130 172

Positive Percent Agreement (PPA) 93% (95%CI: 81% - 99%)

Negative Percent Agreement (NPA) 100% (95%CI: 97% - 100%)

Table 2. Performance of the Flowflex COVID-19 Antigen Home Test in Symptomatic subjects

Flowflex COVID-19 Antigen Home Test

RT-PCR method

Positive Negative Total

Positive 28 0 28

Negative 2 78 80

Total 30 78 108

Positive Percent Agreement (PPA) 93% (95%CI: 78% - 99%)

Negative Percent Agreement (NPA) 100% (95%CI: 95% - 100%)

Table 3. Performance of the Flowflex COVID-19 Antigen Home Test in Asymptomatic subjects

Flowflex COVID-19 Antigen Home Test

RT-PCR method

Positive Negative Total

Positive 11 0 11

Negative 1 52 53

Total 12 52 64

Positive Percent Agreement (PPA) 92% (95%CI: 62% - 100%)

Negative Percent Agreement (NPA) 100% (95%CI: 93% - 100%)

Table 4. Cumulative PPA results by days since symptom onset

Days Since

Symptom Onset

Specimens

Tested

# Cumulative Positive

Flowflex COVID-19

Antigen Home Test

Cumulative Positive

RT-PCR

Cumulative

PPA

0 to 1 day 29 6 7 86%

0 to 2 days 64 15 16 94%

0 to 3 days 90 20 21 95%

0 to 4 days 96 21 22 95%

0 to 5 days 100 23 24 96%

0 to 6 days 106 26 28 93%

0 to 7 days 108 28 30 93%

Asymptomatic 64 11 12 92%

Patient Demographics:

A total of 172 patients participated in the clinical study. Ages of patients ranged from 2 years to 93 years.

Age distribution and the positive results broken down by age of the patient are shown below.

Table 5. Age distribution of patients and specimen positivity

Age Group

Flowflex COVID-19 Antigen Home Test (N=175)

Total Total Positive Prevalence

2-13 years 18 5 28%

14- 24 years 25 4 16%

25- 64 years 94 21 23%

≥ 65 years 35 9 27%

Total 172 39 23%

Analytical Sensitivity: Limit of Detection (LoD)

The Limit of Detection (LoD) of the Flowflex COVID-19 Antigen Home Test was determined using limiting

dilutions of the heat-inactivated SARS-CoV-2 virus (USA-WA1/2020). Nasal swabs from healthy donors were

collected and eluted with PBS. The swab eluates were combined and mixed thoroughly to create a negative

clinical matrix pool to be used as the diluent. Inactivated SARS-CoV-2 virus was diluted in this negative clinical

matrix pool to generate virus dilutions for testing.

The contrived nasal swab samples were prepared by absorbing 50 µL of each virus dilution onto the swab.

The contrived swab samples were processed and tested according to the package insert.

SARS-CoV-2 Concentration in nasal matrix Number of Positives/Total % Detected

2.5 x 10

TCID

/mL 60/60 100%

LoD was determined as the lowest virus concentration that was detected ≥ 95% of the time.

Based on this testing, the LoD in nasal matrix was confirmed to be 2.5 x 10

TCID

/mL

Analytical Specificity: Cross-Reactivity and Microbial Interference

Cross-reactivity was evaluated by testing a panel of related pathogens and microorganisms that are likely to

be present in the nasal cavity. Each organism and virus were tested in the absence or presence of heat-

inactivated SARS-CoV-2 virus (USA-WA1/2020) at a low concentration.

No cross-reactivity or interference was observed with the following organisms when tested at the

concentration presented in the table below.

Potential Cross Reactant Test Concentration

Cross-Reactivity

Results

Interference Results

Virus

Adenovirus 1.14 x 10

TCID