Product Manual

ManualsBrandsLifeSign ManualsFlu/Influenza A+B TestStatus Flu A & B Test Kit - 25 Tests

Table Of Contents

Status Flu A

Nasopharyngeal Wash/Aspirate Sample Procedure

(Purchase of BSP-510AS required)

PROCEDURE

TEST DEVICE

Slowly

Tap

Extraction

Reagent

Influenza

Date______

ID________

Influenza

Date______

ID________

Influenza

Date

Extraction Well

Result Window

Squeeze

here

Star t timing.

Sample

Slowly

Tap

Influenza

Date______

ID________

Influenza

Date______

ID________

Influenza

Date______

ID________

Influenza

Date______

ID________

PROCEDURE

TEST DEVICE

Influenza

Date

Extraction Well

Result Window

Swab Stand

Star t timing.

Status Flu A

Swab Sample Procedure

Reproducibility

The reproducibility study for Status Flu A & B test was conducted at two

physicians’ offices and one laboratory using a panel of 90 coded specimens for

each site. Testing was performed by two personnel for five days at each site. The

panel consists of coded samples of high negative, low positive and moderate

positive specimens for each of influenza A and B. For influenza A and B positive

samples, A/PR/8/34 (H1N1) and B/Maryland/1/59 were used. The low positive

was the LOD level of each strain. Each specimen level was tested in triplicate

every day per operator. Each operator conducted the tests using the coded

samples following the test protocol given in the package insert as if they are

testing patient sample including the sample extraction step.

The results obtained at each site agreed 100% with the expected results. No

differences were observed within run (15 replicates), between runs (five different

days), or between sites (two POL sites and one lab).

Analytical Sensitivity

Limit of Detection (LOD)

The LODs were determined for each of the two strains selected from the

influenza type A and type B strains listed in the analytical inclusivity (sensitivity)

section below. The sensitivity level of each selected viral strain established in the

above study analytical inclusivity (sensitivity) study was tested 60 times to

confirm the sensitivity level as LOD level, which gives 95% detection rate.

All four viral strains tested were detected 96.7% of the time in 60 replicates.

Influenza

Type

#Positive/

#Total

% PositiveViral Strain TCID

/mL

A A/PR/8/34 (H1N1) 1.05 X 10

58/60 96.7

9.95 X 10

A A/Victoria/3/75 (H3N2) 58/60 96.7

1.58 X 10

B B/Taiwan/2/62 58/60 96.7

1.99 X 10

B B/Maryland/1/59 58/60 96.7

Influenza

Type

Viral Strain TCID

/mL

A A/PR/8/34 (H1N1) 1.05 X 10

1.73 X 10

A A/FM/1/47 (H1N1)

4.10 X 10

A A/NWS/33 (H1N1)

8.5 X 10

A A/Hong Kong/8/68 (H3N2)

7.20 X 10

A A/Denver/1/57 (H1N1)

9.95 X 10

A A/Aichi/2/68 (H3N2)

9.95 X 10

A A/Victoria/3/75 (H3N2)

1.99 X 10

A A/Port Chalmers/1/73

9.95 X 10

A A/New Jersey/8/76 (H1N1)

5.00 X 10

B B/Lee/40

1.58 X 10

B B/Allen/45

9.95 X 10

B B/GL/1739/54

1.58 X 10

B B/Taiwan/2/62

1.99 X 10

B B/Maryland/1/59

5.00 X 10

B B/Mass/3/66

2.94 X 10

B B/R75

1.6 X 10

-1

B B/R22 Barbara

3.16 X 10

B B/Russia/69

2.88 X 10

B B/Hong Kong/5/72

5.00 X 10

A/WS/33 (H1N1)

1.58 X 10

A/Swine/1976/31

6.15 X 10

A A/CA/07/2009 (H1N1)

9.31 X 10

A A/CA/08/2009 (H1N1)

8.51 X 10

A A/Mexico/4108/2009 (H1N1)

2.5 X 10

A A/NY/18/2009 (H1N1)

1.08 X 10

A A/CA/07/2009 NYC, X-179A (H1N1)

2.32 X 10

A/Virginia/ATCC2/2009 (H1N1)

5.00 X 10

A/Virginia/ATCC3/2009 (H1N1)

1.00 X 10

2009 H1N1 Clinical Isolate* (Swine Origin Influenza A)

Analytical Inclusivity

The analytical inclusivity (sensitivity) was established for a total of 29

influenza strains: 19 strains of influenza A type and 10 strains of influenza B

type. The results are shown in the table below.

*Clinical isolate cultured and tittered. Culture confirmed positive for 2009 H1N1

Influenza A strain using proFLU Influenza A Subtyping

Flu A

Positive

Status

Flu A & B

Flu A

Positive

Flu A

Negative

Total Agreement

Flu A

Negative

Total

50 0 50 100%

0 30 30 100%

50 30 80

Reference (Virus Culture) Results

Flu B

Positive

Status

Flu A & B

Flu B

Positive

Flu B

Negative

Total

Agreement

Flu B

Negative

Total

30 0 30

100%

0 50 50 100%

30 50 80

Reference (Virus Culture) Results

Flu A

Positive

Status

Flu A & B

Flu A

Positive

Flu A

Negative

Total Agreement

Flu A

Negative

Total

50 0 50 100%

0 30 30 100%

50 30 80

Reference (Virus Culture) Results

Flu B

Positive

Status

Flu A & B

Flu B

Positive

Flu B

Negative

Total Agreement

Flu B

Negative

Total

30 0 30 100%

0 50 50 100%

30 50 80

Reference (Virus Culture) Results

Swab Sample

As further verification of the PCR test results shown from the samples with

discrepant results between Status and viral culture, available archived remnant

samples from the clinical studies with concordant results were also tested by PCR.

The PCR was performed on 138 Flu A negative and 27 Flu A positive samples with

Status and culture, and 154 Flu B negative and 11 Flu B positive samples with

Status and Culture. The specificity for both Flu A and Flu B was 100%, while the

sensitivity for Flu A was 90% and the sensitivity for Flu B was 91.7%.

Archived Sample Test Results

Eighty (80) frozen archived samples originally obtained from influenza positive

patients visiting Columbia NY Presbyterian Hospital and confirmed as positive for

either influenza A or Influenza B by viral culture were tested with Status Flu A & B.

The tables below present test results with archived samples.

Aspirate Sample

Squeeze the Extraction Reagent

capsule to dispense all of the

solution into the Extraction Well

of the test device.

Place the specimen swab on

the Swab Stand in the

Extraction Well.

Incubate 1 minute

with the swab in

Extraction Well.

Tear the tab off the Extraction

Reagent Capsule.

Draw nasal wash or

nasopharyngeal aspirate sample

to the first (lowest) mark of the

graduated transfer pipette.

Dispense all of the solution

in the transfer pipette into

the Extraction Well of the

test device.

Incubate 1 minute.

Re-cap the Extraction

Reagent bottle.

Raise the test device

upright (see picture).

Let it stand for 1-2 seconds.

Tap the device on a flat surface

to ensure that the liquid flows

into the hole.

Read test results at 10-15

minutes.

Confirm negative results at 15

minutes.

Immediately after tapping,

slowly lay the device back

down onto the flat surface.

Dispense the entire

sample in the transfer

pipette into the

Extraction Well of the

test device.

Hold the device with

one hand and the

swab with the other.

While pressing down

on the swab, rotate it

completely in one

direction 3 times to

mix the specimen.

Hold the device with

one hand and the

swab with the other.

While pressing down

on the swab, rotate it

in one direction 3

times to mix the

specimen.

Remove and discard

the swab.

Raise the device upright

(see picture).

Let it stand for 1–2

seconds. Gently tap the

device on a flat surface to

ensure that the liquid

flows into the hole.

Immediately after tapping,

slowly lay the device back

down onto the flat surface.

Read test results at 10-15 minutes.

Confirm negative results at 15

minutes.

Using a new transfer

pipette, draw Extraction

Reagent Solution to the

first (lowest) mark.