FLU OIA^®
(BioStar/biota)

Directigen^®
Flu A
(Becton-
Dickinson)

ZstatFLU^™
(ZymeTx, Inc.)

Viral Culture Isolation

Influenza A EIA PRIMA System^™ EIA
(Bartels)

Detects Types A and B

YES

NO

YES

YES

NO

Technology

Optical ImmunoAssay
(amplified, antireflective thin film technology)

Non-specific capture on membrane
(w/ antibody detector)

EVEA
(specific ligand conjugated to colored precipitating substrate)

Cell Culture and FA confirmation

Microwell EIA using monoclonals
(antibody sandwich)

Specimen Handling / Transport

No special procedures / detects viable or non-viable antigen

No special procedures / detects viable or non-viable antigen

No special procedures / detects viable or non-viable antigen

Needs viral transport media and cold storage and transport to assure viability

No special procedures / detects viable or non-viable antigen

Acceptable Specimen Types

Nasal aspirates
Nasal Swabs
Throat swabs
Sputum

Nasal aspirates
Nasal Swabs
Throat swabs
Nasal washes

Throat swabs only

All sample types

Nasal washes
Bronch washes
Throat swabs
Nasal swabs

# Reagents /
# Controls

4/2

9/2

3/2

Not applicable

5/2

Hands-on time

< 2 min.

Must wait for solutions to absorb at each step before proceeding to the next step

2-3 minutes

Many steps required at various intervals

Many steps for microwell procedures and calibrating instrumentation

Test time

15 min.

~15 min.
NOT including membrane absorption wait times

30 min.

2-10 days for pos.
10-21 days for neg.

~2 hours

Disadvantages

• tests must be read in well-lighted area

• only detects Flu A
• excessive mucoid samples may not absorb into the membrane
• tests must be read in <25 minutes or use stop solution
• incomplete triangles are considered uninterpretable results
• tests must be read in well-lighted area

• low sensitivity
• 30 minute incubation step at 37^oC
• not truly POC test / too long for patient to wait on results
• positive and negative controls must be performed with each new test operator
• must use foam swab provided in kit

• delay in results / not POC test
• storage and transport concerns
• costly
• requires skilled technique and interpretation

• needs instrumentation
• not POC test
• wash solution removal is essential to performance
• must be read within 30 min.
• complicated mathematics required for pos. and neg. cut-off values
• has "gray zone" results that must be repeated

Viral Strain

Strain Type

FLU OIA^®

Directigen^®
Flu A

ZstatFLU^™
(ZymeTx, Inc.)

Hong Kong/68 H3N2

A

1:1500

1:1500

1:1000

Shangdong/9/93 H3N2

A

1:2000

1:1500

1:1000

Texas/36/91 H1N1

A

1:1500

1:1500

1:1000

Wuhan/359/96 H3N2

A

1:1500

1:500

1:1000

Bayern/7/95 H1N1

A

1:2000

1:1000

np

Singapore/1/57

A

1:1500

1:2000

np

Panama/45/90

B

1:1000

n/a

1:1000

Bejing/189/93

B

1:400

n/a

1:300

Guangdong/5/94

B

1:2000

n/a

1:500

Victoria /2/87

B

1:1000

n/a

1:250