After a second washing, the pette is filled a photoreagent mixture which,

when combined with the enzyme-labeled anti-lgE antibody gives off a chem-
ically generated light (i.e. chemiluminescence). The amount of light emitted

HITACHI
by each well is directly proportional to the amount of allergen-specific IgE in
the patient's serum.

.. Reagents/Components
Hitachi Chemical Diagnostics, Inc. OPTIGEN Assay
Store at 2-8°C until expiration date. Do not freeze.

Component Description Each 20-Test KIt Includes

INTERNATIONAL PACKAGE INSERT FOR Test Chambers 20 Pettes
Pette test chamber contains a polystyrene
OPTIGEN®ASEAN solid phase and integrated lenslets, each
Part Number 85046
CE with an allergen or allergen mix.

For in vitro diagnostic single use

Wash Buffer Concentrate One bottle, 50 mL
Doc.No. 0972 Solution that when diluted
Rev.: DRAFT contains 0.01 M phosphate-buffered
saline, 0.1% Tween 20, and 0.001%
sodium azide as preservative
.. Intended Use
Antibody Reagent One bottle, 16 mL
The OPTIGEN Assay is an in vitro diagnostic test for use in the semi Solution containing:
quantitative determination of circulating allergen-specific IgE concentra- Blue-colored solution containing Enzyme-
tions in human serum. It is intended to aid in the clinical diagnosis of IgE labeled goat anti-human IgE, 0.01 M
mediated allergic disorders in conjunction with other clinical findings. The phosphate-buffered saline, pH 7.2, protein
device is designed for use in clinical laboratories. stabilizers, 0.1% Proclln? as a preservative.
Photoreagent AS One bottle, 8 mL
IISummary and Explanation of the Test Solution containing:
7-15 mM 3-aminophthalhydrazide(Iuminol),
5'251-lMEnhancer and 0.025 M Borate Buffer, pH 9.4
Immunoglobulin E is a distinct class of serum antibody, which mediates
Type 1 hypersensitivity reactions, also known as atopic allergy. When Photoreagent CD One botUe,8 mL
immunocompetent B lymphocyte cells are stimulated by exposure to an Solution containing:
antigen (allergen), they may produce allergen-specific IgE antibodies 0.00125 M Ethyl Orange,
which bind to receptors on mast cells and basophilic leukocytes. 0.002 M Hydrogen Peroxide
Pette Plugs (top) 22 plugs
If the same allergen is reintroduced into the system through inhalation, Black plugs for the top of the pelle
ingestion or dermal contact. the allergen binds with the cell-bound IgE
antibodies. This triggers cell degranulation and release of vasoactive Pette Plugs (bottom) 22 plugs
White plugs for the bottom of the pette

mine, are
amines intoresponsible for the
the surrounding bronchial
tissues. smooth muscle
Vasoactive amines,contraction, der-
such as hista-
mal itch, localized swelling and leakage of extracelluar fluids across mu-
cosal barriers that typify Type 1 hypersensitivity reactions.
The most common clinical manifestations of Type 1 hypersensitivity reac-
tions include sinusitis, asthma, dermatitis, hives and in rare cases, ana-
phylactic shock.
Assessing the level of allergen-specific IgE in a patient's serum in con-
junction with a clinical evaluation based on patient history and subse-
quent testing can help a physician confirm a diagnosis of atopic allergy
and assist in the treatment of the patient.
IIPrinciple of the Procedure
The OPTIGEN Assay employs a small plastic device known as a pette or
test chamber to expose patient serum simultaneously to a number of
allergens or allergen mixes. The pette contains a polystyrene solid phase
and integrated lenslets, as well as one Negative blanking control and one
Po"itive procedural control.
The OPTIGEN assay can be run manually or with the semi-automated pro-
cessor AP 720STM.
The assay is run by filling a pette with patient serum after a pre-wash step. - Rinse Wash Buffer Dispenser and tubing with distilled water.
As the serum incubates, IgE in the serum binds to the allergen-coatedwells. -
After an incubation period, the pette is washed with buffer solution to re- - Add contents of Wash Buffer Concentrate bottle (50 mL) to a 2 L Wash
move any unbound serum components.
� Fill Wash Buffer Dispenser Bottle to 1000 mL mark with distilled or de-
Next, an enzyme-labeled anti-lgE antibody is introduced into the pette. The
antibody couples with the IgE bound to the wells.
Antibody Reagent:
II
Precautions
- The OPTIGEN Assay is for in vitrodiagnostic use.
- The Wash Buffer Concentrate contains sodium azide as a preservative.
Sodium azide has been reported to react with lead or copper plumbing to
form potentially explosive metal azides. Therefore, use caution when
disposing of this reagent, and always flush with an adequate volume of
water to prevent metal azide buildup in plumbing systems.t
- Do not use kit components after the expiration date. The expiration date
is printed on each component.
Component reagents of the OPTIGEN Assay kits are provided as
matched sets (i.e. reagents and peUes). Do not mix with other product
-
fines,as they are not compatible.
Bleach contamination has been found to interfere with the test.
mReagent Preparation
Wash Buffer:
-
Allow Wash Buffer Concentrate to reach room temperature, checking to
see that any sail crystals that may have formed during refrigeration have
dissolved. If crystals persist, place tighlfy closed buffer boltle into
a beaker of warm water until all crystals are dissolved.
Gently invertWash Buffer Concentrate bottle several times to mix.
Buffer Dispenser Boltle.
ionized water.
Mix thoroughly.
Once prepared, the Wash Buffer solution can be used for up to 1 month
when stored at room temperature (20-25°C) or refrigerated (2-8'C).
- Allow Antibody Reagent to reach room temperature prior to use.
- Gently invert Antibody Reagent Bottle prior to use. 5. Centrifuge clotted blood for 10 to 20 minutes at 2000·3000 x g or
- Antibody Reagent can be used until the expiration date if kept refrig· 2500·3600 rpm in the original stoppered container.
erated (2·8°C) while not in 6. Transfer serum from centrifuge tube to an appropriately labeled,
use. clean plastic storage tube.
- One bottle of Antibody Reagent is sufficient for twenty (20)
OPTI· GEN pettes.

Photoreagent
Mixture:
Prepare Photoreagent Mixture just before use.
e Allow Photoreagents AB and CD to come to room temperature prior
to use.
o Using a micropipette with disposable tips, combine equal parts
of
Photoreagent AB and CD. Draw 250 -(Lof fluid per pette, from each
bottle of Photoreagent AB and CD. Dispense into a disposable con-
tainer.
NOTE: Use a new disposable tip for each photoreagent corn-
ponent to avoid contamination of
reagents.
- Gently swirl the container to mix.
- Photoreagent mixture should be used within 60 minutes of mixing.
NOTE: Photoreagent Mixture should be used immediately after
preparation for best results.

II Storage Instructions
- Store kit components at 2·8°C. When stored as directed, the corn-
ponents can be used until the expiration dates printed on the indio
vidual component labels.
- Do not freeze kit components.
- The pettes are packaged with desiccant and should be sealed
properly after each use. When stored in the sealed bag and refriq-
erated at 2·8°C, pettes will be stable until the expiration date printed
on the labelslkit boxes.
- Do not use kit components if signs of deterioration are
present.
Signs of deterioration include unusual odor, turbid appearance, and
other indications of
contamination.

iii Specimen Collection and

Preparation
Handle all patient samples and used kit components as recommended for
any potentially infectious human serum or blood specimen. Follow Uni-
versal Precautions or other guidelines as established by your institution
when handling patient specimens.z-a

For the manual method, the minimum volume of human serum required
per individual pette is as follows:
500 IIIfor a> 20.allergen pette
300 ilL for a - 20·allergen pette

For the semi-automated method (using the AP 720S), the

minimum volume of human serum requiredper individual pette is
as follows:
600 IIIfor a > 20-allergen pette
490 ul, for a - 20·allergen pette
The following protocol should be used when collecting, preparing,
and storing serum for use in OPTIGEN allergy testing:
1.
Collect a venous blood sample into a 5 mL serum separator tube or
red-top tube. Patient need not be fasting. No special preparations
are necessary.
NOTE: Serum separator tubes (SST) contain an inert material
which separates the serum from the cells when centrifuged.
Hemolysis can adversely affect the performance of the OPTt·
GEN allergy assay.
2. Gently invert serum collection tube 3·5
times.
3. Label specimen tube with the patient's name and date of
draw.
4. Allow blood to clot in the original stoppered container for up to
2 hours at room temperature or until co-aqulation occurs.
7. Serum samples may be stored at 2·8°C for up to one week. - CLA·1 Luminometer System
For longer periods, freeze samples at ·20°C.
Preparation of Pettes and Patient Samples
NOTE: Repeated freezing and thawing of serum 1. Centrifuge serum samples immediately prior to use, if the sample has
samples should be avoided. Frozen samples that have not been centrifuged on the test day (see Section 8, Specimen
been thawed should be thoroughly mixed before Collection and Preparation).
centrifugation. After reo moval from storage, and 2. Remove pettes (one per patient) from
immediately prior to perfonnlng the assay, serum samples bag.
should be re-centrlfuged for 10·20 minutes at 2000-3000x 3. Reseal bag and return kit to the refrigerator.
g or 2500·3600 RPM. 4. With windows facing down, label each pette with appropriate
patient
mI Assay identification.
NOTE: Keep kit stored at 2·SoCwhen not in use.
Procedure
Procedure
Refer to the OPTIGEN User Guide (PIN 60501) and the CLA-1 A. Prepare Wash Buffer as instructed In Section 6, REAGENT
Lumi- nometer Operator Manual (Doc. No. 0277) for detailed PREPARATION.
instructions on the manual test operation. If using the AP 720S Semi-
B. Re·hydrate Pette
Automated Instrument, please refer to the AP 720S Instruction Manual
1. Prime the Wash Buffer Dispenser into the sink or reservoir until all
(Doc. No. 0780) and the AP 720S LCD Panel Guide (Doc. No. 0781).
air bubbles are removed.
Materials 2. Attach the end of the stop cock.to the top of the first pette.
Provided 3. Wash each pette once with 10 mL of Wash Buffer by depressing
OPTIGEN Assay (see Section 4, REAGENTS/COMPONENTS) the Dispenser pump once with moderate force.
NOTE: Allow each pette to drain completely before proceed-
Materials Required But Not
Ing to the next step.
Provided
OPTIGEN Equipment Kit, comprising: C. Draw Serum into
-Workstation Rack, which holds up to 40 Test Chambers Pette
-Workstation Reservoir 1. Tap the pette onto an absorbent paper to remove any residual
-Wash Buffer Dispenser bottle, 2 L graduated. liquid.
· Disposable Reagent Cups, 1Omlcups 2. Attach the 3 cc syringe to top of the pette.
3 cc Luer lock syringe 3. Insert bottom of the pette into vial containing patient serum.
Electronic or manual fixed volume pipette (optional) NOTE: Avoid any precipitate and/or lipid layer.
Graduated cylinder or flask, 1 L, for preparing Wash Buffer 4. SLOWLY withdraw syringe plunger to draw serum into pette until
Deionized or distilled water top window is covered. Check for bubbles.
Serum separator tubes or red-top tubes, 10 mL or 5 mL NOTE: Be sure the positive control window is completely
specimen collection covered by serum.
- Centrifuge capable of 2000·3000 x g or 2500·3600 D. Plug and Incubate
rpm Pettes
- Clean, plastic storage tubes for specimen 1. With syringe still attached to top of Test Chamber, insert a white
preparation plug into bottom of the pette.
- Absorbent paper 2. Remove the syringe and insert black plug into top of the pette.
towels NOTE: Plugs should be pushed in completely to prevent
- Clean, lint·free leaking.
wipes
2
 3. Place serum-filled pettes upright in workstation rack. 4. Wipe away any Photoreagent from the outside of the pette with a
4. Incubate at room temperature for 2 hours +1-10 minutes. clean, damp, lint-free wipe.
E. Drain Serum N. Allow Filled Pelles to Stand for 10 Minutes
1. Remove bottom plug 1. Allow all test chambers
from each pette and to incubate for 10
place pette back in minutes before reading in
workstation rack. the luminometer. All test
2. Remove top plug from chambers must be read
each pette, allowing serum to within 60 minutes after the
drain into introduction of
workstation reservoir.
photoreagent.
3. Blot plugs dry and retain 2. Refer to "Reading Test
for use in subsequent steps. Results" section for
Luminometer operation for
additional information.
F. Wash Pettes O. Reading Test Results with the
1. Prime Wash Buffer CLA-1 Luminometer
Dispenser until all air bubbles NOTE: Do not, under
are removed. any circumstances,
2. Attach end of stop cock open the CLA-1
to top of first pette.
Luminometer instrument
case. Opening the case
will VOID
3. Wash each pette with 10 the instrument's
mL of Wash Buffer by warranty, render the
depressing the CLA-1 Luminometer
Dispenser pump once inoperable and
with moderate force. necessitate factory
NOTE: Allow each adjustments, as well as
pette to drain exposing the Operator to
completely before serious personal injury.
proceeding to the next 1. Load Pette into Pette
step. Cassette Tray
G. Fill Pettes with Antibody a. Insert the pette into the
Reagent Pette Cassette in the order
1. Allow Reagents to come indicat-
to room temperature prior to ed on the OPTIGEN
use. Planner Sheet.
2. Gently mix the antibody b. Slide the pette, black
bottle prior to use. plug first with windows
3. To avoid contamination faclnq up, all the way
of Antibody reagent, transfer to the end of the Pette
required Cassette Tray.
c. Inspect loaded pette for
amount to a disposable fluid leakage. Wipe with a
cup or other container. clean,
4. Gently damp, lint-free wipe.
tap 2. Load Pette Cassette into the
bottom CLA-1 Luminometer
of pette
tip on
absorbe
nt paper
to
remove
any
remaini
ngWash
Buffer.
5 Attach the 3 cc syringe to the top of a Press the 'OPEN/CLOSE" key
6
. thePlace bottom of pette into
pette. . once
on the to CLA-1
open theluminometer
Transport
.7 disposable Antibody Reagent
SLOWLY withdraw syringe b Grasp
Door. the handle of the Pette
. into
plunger to draw
the pette, untilAntibody
top window Reagent
is . ed
Cassette and
tray into theinsert the load-
Cassette
covered. c Transport slot, until it clicks.
NOTE: Reagent.
tibody Be sure the top will
This window
limit is . Pette
Press Cassette will
the "OPEN/CLOSE"
the formation
which of airwith
may interfere bubbles,
test automatically
CLA-1 be transported
Luminometer and the
results. Transport Door will close.

H. Plug and Incubate Pettes temperature for 2

1. Insert white bottom plug hours +1-10
into pette with syringe still minutes, noting
attached to top of the incuba- tion start
pette. lime on the Planner
2. Remove syringe and Sheet.
insert black top plug.
NOTE:
3. Store reagent-filled
pettes upright in Keep kits stored
workstation rack. at 2-SoCwhen not
Incubate at room
3 in use. L Drain
Antibody 3. Program the Load List 2. Attach syringe to the top of I
into the CLA-1 Luminometer the pette.
Reagent n
a. Identify the panel 3. Place bottom of pette into
1. Remove bottom plug t
from each pette and place loaded into each container of Photoreagent
each pette back of the 5 positions e
Mixture.
in the workstation in the pette r
4. SLOWLY withdraw
rack. cassette, using n
syringe plunger to draw
the Luminometer a
Photoreagent Mix-
Planner Sheet as ture into the pette, until the l
a guide. pette is completely filled.
b. Press the 'UP" or NOTE: Verify the top C
"DOWN" keys on window is completely o
the CLA-1 covered with n
Luminome- ter to t t
scroll through the h r
panel selections. e o
c. Press the 'ENTER" l
key when the P
appropriate selection is h
displayed with the W
o e
listed Cassette t
position. l
o l
d. Repeat the above r
steps until all of the s
e Each pette contains a Positive
pettes in the Petie a
Cassette have Procedural Control and a
g
been properly Negative Blanking Control.
e
programmed into These controls function as
n
the CLA-1 internal indicators for each pette.
t
Luminometer. Positive Procedural Control:
4. Read and Print Results M The Positive Procedural
2. Remove top plug from each pette, allowing liquid to drain into i a. Control
After all 5 Pette Cassette checks have
positions the performance
been
workstation reservoir. Note incubation stop time on the Planner x grammed, the CLA-1 Luminometer
pro- screen will
of kit reagents. Thedisplay a
Positive
Sheet. t corresponding 'LOAD L1sr. If it correclfy
Procedural matches must
Control the
J. Wash Pettes begin analysis.
pettes in the Pette Cassette,
generate
pressa the
reading
"ENTER"
greater
keythan
to
3. Blot plugs dry and retain for use inb.subsequent steps. u
1. Prime Dispenser into The CLA-1
r or equal to 243 LU in the CLA-1
the sink or reservoir Luminometer
e Luminometer.
until all air bubbles will print out the
. Negative Blanking Control:
are removed. test results in
ap- proximately The Negative Blanking Control
2. Attach M com- pensates for any
1 minute. .
end of stop c. Write the nonspecific IgE binding that may
cock to the patient's name occur. The Nega- tive Blanking
top of the P Control must generate a reading
on the printed l
first pette. test results and of equal to or less than
u
at- tach results 6
g
the to the Test 9
Dis Record for the P
pen CLA-1 e L
ser Luminometer. t U
pu Quality Control
t
mp
onc
110 e
s
i
n
e 1. Insert the white bottom
with plug in pette with the syringe
still at- t
mo
h
der
e
ate
forc
e. C
L
3. Wash each pette once with 10 mL of Wash Buffer by
A
depressing
-
NOTE: Allow each prior to use. 1
pette to drain NOTE: Use
completely before photoreagent
L
pro- A. ceeding to mixture
u
the next step. immediately
m
K. Prepare Photoreagent after prepa-
i
Mixture ration for
best results. n
1. Prepare L. Fill Pette with o
Photoreagent Photoreagent Mixture m
Mixture as 1. Gently tap bottom e
instructed in of pette on an t
Section 6, Rea- absorbent paper to e
gent Preparation. remove any r
NOTE: Allow .
photoreagents to Wash Buffer
come to room remaining in pette. Unacceptable Internal Control
temperature Outcomes: If a result for either
4
in- ternal control is not within reread. P 2
acceptable limits as defined . r 3
above. the fol- lowing actions � If results are e 4
should be taken: still unacceptable, c
i Between-Assay: Ten
Re-position pette in Pette refer to Sections 6 replicates of a serum sample
Cassette (ensuring that the s
and 7. i were run on five different days.
pette is ful- ly inserted) and The mean coefficient of variation
o
tached to B. IgE Positive and
n of the responses of all allergens
the top. Negative Control Sera tested was calculated per class:
2. Remove Hitachi Chemical 5
the syringe and Diagnostics Class
recommends that each Within-Assay: Ten serum
insert the black %CV
new kit lot of replicates were run in one batch.
top plug. reagents and pettes 1
The av- erage mean coefficient of
3. Inspect used in performing 25
variation of the responses was
plugged pette the OPTIGEN 2
for fluid leaks. calculated per class:
AUergen- 15
Class 3
Specific IgE Assay be
tested with two levels of III Expected Values 4 >
1
VeryhiQh levels
9
4
serum controls: IgE It is recommended that 3 143-
2 of Hiqh levels of
antibodies
Positive Control Serum each laboratory 2 242 antibodies
66- Moderate levels B Detection limit 5
and IgE Negative Control establish its own 1 142
27- of antibodies
Low levels of . The detection limit of the assay
Serum. expected range of 0 65
0 antibodies
No antibodies ranges from 12- 26 LUs and is
dependent.
Regulatory agencies may values for the - detected
require more frequent population of interest.
use of Positive and The cut-off threshold CLA Class values of 1 or towards altered forms of
Negative control sera. between positive and above represent progressively allergens (such as cooked,
Check with your regulatory negative results was increasing concentrations of processed, or digested) and
agency for specific details. established as three allergen-specific antibodies. CLA the altered forms are not
standard deviations Class 0 represents an absence of present in the same form as
OPTIGEN IgE Positive above the mean value or nondetectable levels of those food allergens that are
and Negative Control of the normal
Sera are available for
allergen-specific antibodies. used in this test. False-
population. positive test results in
purchase from Hitachi
Chemical Diagnostics,
Inc. and are shipped with
III Petformance IE personswho are tested for
food allergies may lead to
a printout of expected Characteristics for Limitat inappropriate dietary
values. Control sera are ions restriction, while false-
negative results in food-
shipped frozen and must Standard of the sensitive persons may result
remain frozen unlil used.
Procedure Proced in ana- phylactiCreactions of
varying severity.
Internal controls and Serum (LUs). To calculate ure • When testing for inhalant
control need to pass the patient's IgE • Measured results could vary allergies, false-positive results
specifications in or- A. der response, the within +/- 1 class. Low may lead to improper
for the results to be instrument positive results should be medication of those persons,
reportable. automatically subtracts interpreted in conjunction False-negative test results

m the emission level of

the Negative Control
from the emission level
•
with clinical findings.
Hemolyzed or lipemic serum
may adversely affect the
of each allergen. CLA performance of the
Class Values are OPTIGEN Assay.
assigned from 0 to 4 Definitive clinical diagnosis
based on the amount and/or dosage regimens for
R of light emitted by the immuno- therapy should not
individual allergens in be based solely on the
the pette. These results of any single diag-
e values make up the nostic test, but should be
CLA Class made by the physician after
s Allergy Scoring all clinical and laboratory
System of the findings are evaluated.
OPTIGEN Allergen- • The OPTIGEN Assay
u Specific IgE Assay. provides semi-quantitative
The amounts of IgE results. The meth- od has
associated with CLA no absolute standard and
l Class values and has been arbitrarily assigned
instrument readings are lev- els of classification.
t listed in the following • Since the binding capacity
table. for specific IgE antibody
may vary from allergen to
s levels allergen, similar
The CLA-1 l.umlnorneter anubodte classifications of different
measures the amount of dsetected allergens do not necessarily
light emitted by the CLAClass imply clinical equivalence.
NetLUs Allergen- When testing for food
allergens in the pettes. Specif1ic9EConcentr
The luminometer allergies, circulating IgE
ation
measures light emission antibodies may not be
in luminescence units detected if they are directed
5
C Hitachi
is approximately 90%; response should be Chemical low
. the range of interpretedwith caution. Diagnosti er
cs. Inc. Coo
concordances is 83% to Reliable and reproducible 630 kha
A Clyde
n 98%. results will be obtained Court
m
Roa
a Note: There are no when the assay Mountai
d
procedure is carried out in n
l standardized reference complete accordance with View.C Mai
y the product's den
allergens available for alifornia
hea
t 94043
i comparison between TeL d,
methods, nor for the great (650) Ber
c 961�5 kshi
a majority of clinically relevant 501 re
l allergens. Fax SL6
(650) 8YA
S
p 1 969-
2745
Unit
ed
Kin
e ©2010. Hitachi

m
gdo
c Chemical
m
Diagnostics. Inc
l TeL +44 (0)
f 1628585590
Fax +44 (0)
i
c B 1628585594

i OPTIGEN is a registered trademark of Hitachi

t
i instructions for use and Chemical Diagnostics, Inc.
adherence to good quality
y b control proce- Manufa<:iured under one or more of the folkrlling
5
There is no detectable
l durss. Un'lted States Palent Nos.: 3.941,876. 4,031,197,
4,459.360
in Canada. (and corresponding
Australia. patentsFrance.
Japan. Spain. issued
i • Bleach contamination has Germany, Italy, Sweden, and Great Britain),
4,510,393,4,558.013.5,567,149
cross-reactivity with (and
been found to interferewith the correspooding patents issued
human serum immuno- o test. in Canada, Australia, Japan. Spain, France,
Germany. Italy, Sweden, Switzerland. Austria.
globulins IgA, IgM, IgG,
or IgD at normal
g Labware that has been Belgium. the Netherlands. Luxembourg. and
Great Britain). 4.568.184, 285.485. 4,743.541
decontaminated with bleach
physiological levels. r solution should
(and corresponding palents issued in Canada.
Auslralia. Japan. Fra-. Germany. Sweden,
D a be rinsed thoroughly with
Switzerland. and Great Brit- ain), and 5,082,768
(and corresponding patent Issued in Japan).
. p distilled or deionizedwater.
NOTE: The usesolutions
of
I
h alcohol-basad
to disinfect the
workstation will result in
n y cracking of the plastic and
premature
-
failure of the workstation.
V 1. Safety Management No. CDC-22.
i Decontamination of/af>oratO/'j sink
drains to remove azide
t salts. Atlanta. GA: Centers for
r Disease Control, April 30. 1976.
2. U.S. Dept. of Health and Human
o Services. Centers for Disease Control.
Guidelines For
Prevention of Transmission of
A Human lmmunodeficiency Virus
and Hepatitis B Virus to
l Health-Care and Public-Safety
l Workers. February 1989.
e 3. Richardson SH, Barkley WE, eds.
Biosafety in miCfobio!ogi~1 and
r biomediC<//laf>ora/ories
g 2nd ed,
y Wash'ngton.
DC: US
Dept of
Health and
M Human
e Services,
1988.
t 4. Federal OSHAStai1dard 1910.1030.
h B/oodbome pathogens. 29 CFR
1910.1030.
o 5. Data available upon request.
d
For technical assistance,
c please contact Hitachi
o Chemical Diagnostics. Outside
m the United States, please
p contact your local Hitachi
a Chemical DiagnostiCS
r representative.
i
s IEeJ
I
o
n ep
"
Hitachi
On average, Cl1<lmical
Diagnostic
concordance (calculated s. Inc.
as efficiency) between Hitachi
Europe
each CLA allergen and Ltd.
alternate in-vitro assay lNhitebro
ok Park
may lead to lack of IU/ level
proper medical mL al-
treatment. , lergen-
If total IgE values are low specific
greater or equal to 2500 - IgE 6