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ManualsBrandsBeckman Coulter ManualsFecal Occult Blood TestHemoccult II SENSA Single Slides

Physicians’ #1 Choice in Enhanced Fecal Occult Blood Testing

With On-Slide

Feature

Product

Instructions

INTENDED USE

The Hemoccult SENSA test is a rapid and qualitative method for

detecting fecal occult blood which may be indicative of gastro-

intestinal disease. It is not a test for colorectal cancer or any other

specific diseases.

The Hemoccult SENSA test is recommended for professional use

as a diagnostic aid during routine physical examinations, for hos-

pital patients to monitor for gastrointestinal bleeding in patients

with iron deficiency anemia or recuperating from surgery, peptic

ulcer, ulcerative colitis and other conditions, and in screening pro-

grams for colorectal cancer when the Patient Instructions are

closely followed.

1-4, 22

Serial fecal specimen analysis is recommended when screening

asymptomatic patients.

3, 5

The Hemoccult SENSA test and other unmodified guaiac tests

are not recommended for use with gastric specimens.

SUMMARY AND EXPLANATION OF THE TEST

Van Deen is generally credited with the discovery that gum gua-

iac, a natural resin extracted from the wood of Guaiacum officinale

is useful in detecting occult blood.

The Hemoccult SENSA test more reliably detects abnormal

bleeding associated with gastrointestinal disorders than standard

guaiac tests. As a result, it will have a higher sensitivity for disease

but also a higher false-positive rate among non-diet compliant

patients. Hemoccult SENSA positive test results appear as more

stable, intense blue color reactions than the results of other guaiac

tests, improving overall readability and precision. As with other

guaiac tests, accuracy depends upon the status of the patient at

the time the specimen is taken and may be affected by interfering

substances.

The Hemoccult SENSA test, like the Hemoccult test, is a simpli-

fied and standardized variation of the laboratory guaiac procedure

for detection of occult blood. The Hemoccult SENSA test formu-

lation includes an enhancer which makes the test more sensitive

and more readable than other guaiac-based tests. Because the

Hemoccult SENSA test requires only a small fecal specimen,

offensive odors are minimized and storage or transport of large

fecal specimens is unnecessary.

PRINCIPLES OF THE PROCEDURE

The Hemoccult SENSA test is based on the oxidation of guaiac

by hydrogen peroxide to a blue-colored compound. The heme

portion of hemoglobin, if present in the fecal specimen, has per-

oxidase activity which catalyzes the oxidation of alpha-guaiaconic

acid (active component of the guaiac paper) by hydrogen perox-

ide (active component of the developer) to form a

highly conju-

gated blue quinone compound.

REAGENTS AND MATERIALS

The Hemoccult SENSA test consists of two main components:

• Hemoccult SENSA Slides (Test Cards) containing guaiac paper

• Hemoccult SENSA Developer– a developing solution

containing a stabilized mixture of less than 4.2% hydrogen

peroxide, 80% denatured ethyl alcohol and enhancer in an

aqueous solution.

Hemoccult SENSA Single Slides are convenient for use when

single fecal specimens are tested.

Hemoccult II SENSA Slides, in cards of three tests, are designed

so patients can collect serial specimens at home from bowel move-

ments over three days. After the patient prepares the Hemoccult II

SENSA test, it may be returned in person or by mail (use

Hemoccult Mailing Pouch) to the laboratory, hospital or medical

office for developing and interpretation.

PRECAUTIONS

• For in vitro diagnostic use.

• Do not use after expiration date which appears on each test

component.

• Because this test is visually read and requires color differen-

tiation, it should not be interpreted by individuals with blue color

deficiency (blindness).

• Patient specimens, and all materials that come in contact

with

them, should be handled as potentially infectious and disposed

of using proper precautions.

• Slides (blue and green striped)

Keep cover flap of slide sealed until ready to use. Protect slides

from heat, light, and volatile chemicals (e.g., ammonia, bleach,

bromine, iodine, household cleaners). Hemoccult SENSA slides

present no hazard to the user.

• Developer (blue and green striped label with blue bottle cap)

Hemoccult SENSA Developer should be protected from

heat and the bottle kept tightly capped when not in use. It is

flammable and subject to evaporation.

• Hemoccult SENSA Developer is an irritant. DO NOT USE

IN EYES. AVOID CONTACT WITH SKIN. Should contact occur,

rinse promptly with water and consult a physician.

IMPORTANT: Use Hemoccult SENSA Developer (blue and green

striped label with blue bottle cap) only with Hemoccult SENSA

slides.

Do not interchange Hemoccult SENSA with Hemoccult test

reagents, which are identified by yellow and green striped pack-

aging, or with components from any other manufacturer.

STORAGE AND STABILITY

Store product at controlled room temperature (15 to 30°C) in origi-

nal packaging. Do not refrigerate or freeze. Pr

otect from heat and

light. Do not store with volatile chemicals (e.g., ammonia, bleach,

bromine, iodine, household cleaners).

The Hemoccult SENSA Slides and Developer will remain stable

until the expiration dates which appear on each slide and

developer bottle when stored as recommended.

PATIENT PREPARATION and INSTRUCTIONS

Patients should follow the PATIENT INSTRUCTIONS at least 7 days

prior to and continuing through the test period.

SPECIMEN COLLECTION

The Hemoccult SENSA test requires only a small fecal specimen.

The specimen is applied to the guaiac paper of the Hemoccult

SENSA slide as a THIN SMEAR using the applicator stick provided.

Hemoccult SENSA Slides are best developed no sooner than 3

days after sample application. This allows any fruit and vegetable

peroxidases present in the sample to degrade.

8-10

Slides containing

samples may be stored up to 14 days at room temperature (15 to

30°C) before developing.

Patients using the Hemoccult SENSA test should be instructed to

return the slides to the physician or laboratory immediately after

preparing the last test. IMPORTANT NOTE: Current U.S. Postal

Regulations prohibit mailing completed slides in standard paper

envelopes. Physicians who wish

their patients to return slides by

mail must instruct them to use only U.S. Postal Service approved

mailing pouches.*

Fecal specimens should be collected from bowel movements over

three days. To further increase the probability of detecting occult

blood, separate samples should be taken from two different sec-

tions of each fecal specimen.

3, 5

INTERFERING SUBSTANCES

In general, patients should be carefully instructed to not ingest

foods and vitamins which can cause false-positive or false-nega-

tive test results for at least 72 hours before and through the test

period.

Substances which can cause false-positive test results:

11-14

• Red meat (beef, lamb and liver)

• Aspirin (greater than 325 mg/day) and other non-steroidal

anti-inflammatory drugs such as ibuprofen, indomethacin and

naproxen

• Corticosteroids, phenylbutazone, reserpine, anticoagulants,

antimetabolites, and cancer chemotherapeutic drugs

• Alcohol in excess

• The application of antiseptic preparations containing iodine

(povidone/iodine mixture)

Acetaminophen is not expected to affect test results.

Substances which can cause false-negative test results:

• Ascorbic acid (vitamin C) in excess of 250 mg per day

• Excessive amounts of vitamin C enriched foods, citrus fruits and

juices

• Iron supplements which

contain quantities of vitamin C in excess

of 250 mg per day

PROCEDURE

Materials Supplied:

• Hemoccult SENSA Slides (blue striped)

• Hemoccult SENSA Developer (blue cap and striped label)***

• Applicator sticks

• Patient envelopes with patient sample collection instructions **

• Mailing Pouch for returning completed slides*

• Collection tissues**

• Hemoccult SENSA Product Instructions

** In Dispensapak Plus configuration only.

***Note: Developer is not included in all kit configurations and may

be purchased separately (Product Number 64115). Refer to

PRODUCT INFORMATION section.

IMPORTANT NOTE: Follow the procedure exactly as outlined.

Always develop the test, read the results, interpret them, and

decide whether the fecal specimen is positive or negative for

occult blood BEFORE developing the Performance Monitors fea-

ture. Do not apply developer to the Performance Monitors areas

before interpreting test results. Any blue originating from the posi-

tive Performance Monitors area should be ignored when reading

the sample test results.

TEST PROCEDURE

Hemoccult SENSA and Hemoccult II SENSA

A. Identification

Using a ball-point pen, write

patient name, age, address,

phone number, sample collection

date and physician name on

front of slide in space provided.

B. Preparing the Test

• Using applicator provided, collect

small fecal sample.

• Apply thin smear covering Box A.

• Reuse applicator to obtain second

sample from a different part of

feces. Apply thin smear covering

Box B.

• Close cover flap. Dispose of

applicator in waste container.

C. Developing the Test

• Slides are best developed no

sooner than three days after

sample application to allow for

degradation of any fruit and

vegetable peroxidases that may

be present in the fecal sample.

However, if immediate testing is

required, wait 3 to 5 minutes

before developing.

• Open back of slide and apply

two drops of Hemoccult

SENSA

Developer to guaiac paper directly

over each smear.

• Read results within 60 seconds.

Any trace of blue on or at the

edge of the smear is positive for

occult blood.

D. Developing the Performance

MonitorsFeature (Quality

Control)

• The Performance Monitors areas

must be developed on every slide.

• Apply one drop of Hemoccult

SENSA Developer between the

positive and

negative

Performance Monitors areas.

• Read results within 10 seconds.

If the slide and developer are

functional, a blue color will

appear in the positive Performance

Monitors area and no blue will

appear in the negative

Performance Monitors area.

• Neither the intensity nor the

shade of the blue from the

Positive Performance Monitors

area should be used as a

reference for the appearance of

positive test results.

• Any blue originating from the

positive Performance Monitors

area should be ignored when

reading the sample test results.

NOTES

• Follow the procedure exactly as outlined above.

• W

hen preparing slides for immediate testing, wait as

directed to allow adequate time for sample to penetrate the

test paper before developing.

1 2 3 4

PATIENT INSTRUCTIONS

• For accurate test results, apply samples from bowel move-

ments collected on three different days to slide.

• Do not collect sample if blood is visible in your stool or urine

(e.g., menstruation, active hemorrhoids, urinary tract infection).

Contact your doctor.

• For the most accurate test results collect each stool sample

before contact with the toilet bowl water. You may use any

clean, dry container.

• Return completed slides to your doctor or laboratory no

later than 10 days after your first sample collection.

• Protect slides from heat, light, and volatile chemicals

(e.g., ammonia, bleach, bromine, iodine, household cleaners).

• Remove toilet bowl cleaners from toilet tank and flush twice

before proceeding.

Drug Guidelines

• For seven days before and during the stool collection period,

avoid non-steroidal anti-inflammatory drugs such as ibupro-

fen, naproxen or aspirin (more than one adult aspirin a day).

• Acetaminophen (Tylenol*) can

be taken as needed.

• For three days before and during the stool collection period,

avoid vitamin C in excess of 250 mg a day from supplements,

and citrus fruits and juices.

Diet Guidelines

• For three days before and during stool collection period,

avoid red meats (beef, lamb and liver).

• Eat a well balanced diet including fiber such as bran cereals,

fruits and vegetables.

Notes:

1. Please talk to your doctor or pharmacist if you have any ques-

tions about medications you take regularly.

2. 100% of RDA of vitamin C for an adult is 60 mg a day.

3. Some iron supplements contain vitamin C in excess of

250 mg.

*Tylenol is a registered trademark of McNeil Consumer Healthcare.

Beckman Coulter, Inc.

250 S. Kraemer Blvd., Brea, CA 92821 USA

http://www.beckmancoulter.com/rapids

462489.EF

June 2015

Beckman Coulter, the stylized logo, and Hemoccult, Hemoccult II, SENSA, Gastroccult and

Performance Monitors are trademarks of Beckman Coulter, Inc., and are registered in the USPTO.

DANGER

H225

Highly ﬂammable liquid and vapour.

H303

May be harmful if swallowed.

H315

Causes skin irritation

H318

Causes serious eye damage.

P210

Keep

P233

Keep container tightly closed.

away from heat, hot surfaces,

and sparks. No smoking.

P243 Take action to prevent static discharge.

P280 Wear protective gloves, protective clothing

and eye/face protection.

P310 Immediately call a POISON CENTER or

doctor/physician.

P302+P352

IF ON SKIN: Wash with plenty of

soap and water.

P370+P378

In case of ﬁre: Use water spray for

extinction.

Isopropyl Alcohol 3-6%

Hydrogen Peroxide 3-6%

Ethyl Alcohol 75-85%

Ethyl Paraben 3-5%

GHS HAZARD CLASSIFICATION

Hemoccult SENSA Developer

EUROPEAN HAZARD CLASSIFICATION

Hemoccult SENSA Developer

F;R11

R11

Highly ﬂammable.

S16 Keep away from sources of ignition

- No smoking.

Keep container tightly closed.

Dietary iron supplements will not produce false-positive test

results with Hemoccult SENSA

*Mailing Pouches are included in Hemoccult II SENSA

Dispensapak Plus (Product Number 64130) and may be

ordered separately. Refer to PRODUCT INFORMATION section.

Summary of content (2 pages)

PAGE 1
INTENDED USE The Hemoccult SENSA test is a rapid and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. 462489.EF June 2015 ©2015 Beckman Coulter, Inc.
PAGE 2
Occasionally, a light blue discoloration may be noticed on the guaiac test paper. This discoloration does not affect the accuracy or performance of the test when it is developed and interpreted according to the recommended procedure. When developer is added directly over the fecal smear on a discolored slide, the blue background color migrates outward. A blue ring forms at the edge of the wetted area, leaving the guaiac paper around the fecal smear off-white in color.