!"#$%&'(&)*+
2-N9:1(A>::1.63>8(,7>.1<?71
!""#$!)*+#%,%&'$%($)"*+,$%($+,-./)"01
Immunochromatographic Rapid Test for the
Detection of Fecal Occult Blood
Collect faeces in a clean dry container or receptacle. G>8P6
I71-/(>== the red end of !)*+#%.
,-./-01(2341
28009
!"#$%
28019
28020
24
24
72
72
Test Devices
Collection Tubes
Test Devices
Collection Tubes
!&'(%
*156(,738.39:1
Stool is transferred into a !)*+#%,with transport medium and extracted. This
mixture is added drop by drop to !)#-)%., Human haemoglobin (hHb) in the
sample reacts with reagent consisting of blue coloured particles and
monoclonal anti-human Hb antibodies. The immunocomplex migrates to the
test zone where it is captured by an immobilised second antibody directed
against hHb forming a blue test line (T) to indicate a positive result.
Unreacted reagents migrate further and are bound in a second line by
immobilised anti-mouse IgG antibodies. This control line (C) indicates proper
function and correct handling of the test.
*;1(6156(35(38618<1<(=>7(97>=1553>8-:(?51@
A>861865
!"#$%,BCDDE
,,,,
!"#$%,
BF( *156( G1H3.15 comprising a conjugate consisting of
!)#-)%
blue particles and antibodies (anti-hHb, mouse), immobilised anti-hHb (mouse) and anti-mouse IgG antibodies (goat), individually sealed with desiccant
BF( A>::1.63>8( *?I1 with TRIS buffer pH 7.5 and appli!)*+#%
cator stick
BJ(,-63186(<-6-(:-I1:5
!"#$%,BCDKE
!"#$%,
LB( *156( G1H3.15 comprising a conjugate consisting of
!)#-)%
blue particles and antibodies (anti-hHb, mouse), immobilised anti-hHb (mouse) and anti-mouse IgG antibodies (goat), individually sealed with desiccant
!"#$%,BCDBD
!"#$%,
LB( A>::1.63>8( *?I1 with TRIS buffer pH 7.5 and appli!)*+#%
cator stick
LJ(,-63186(<-6-(:-I1:5
26>7-01(-8<(26-I3:36M
The test kit is stable up to the given expiration date when stored at 2...25°C. It
should not be used beyond the expiration date. Freezing and temperature >
30°C must be avoided.
Unscrew the red cap of !)*+#%, with the applicator stick fixed in the cap holding the tube
upwards, thus assuring not to spill the transport medium.
Avoid skin contact with the transport medium
though it is not dangerous.
Collect sample by immersing the applicator stick
at 3-4 different sites of the faeces.
Remove excess faeces from the applicator
with an absorbent tissue. The amount of
sample remaining in the grooves of the
applicator stick is sufficient for the test.
Reinsert the applicator stick into !)*+#%, and
screw the cap tightly.
The sample now must be tested within one
week.
,17=>7N380(6;1(*156(-8<(+86179716-63>8
Shake !)*+#%,thoroughly to assure proper mixing.
Remove !)#-)%,from the blister and put it on a level surface.
Cover the red cap with a tissue to avoid spilling. Hold
!)*+#%,with the red end upwards and break the tip off.
Dispense exactly 2 full drops into the round
opening (S) at the lower end of !)#-)%.
Wait for about 5 minutes to read the result.
Negative results should be confirmed after 10
minutes.
291.3N18
Dietary restrictions are not necessary for the performance of the HEXAGON
OBTI test.
Unscrew the cap of !)*+#%, and collect sample with the applicator stick by
taking several portions at different sites of the bowl. Remove excess stool with
a tissue. Transfer the applicator into the !)*+#%. The sample thus collected is
stable at room temperature and must be tested within one week after
collection.
Each specimen should be handled with care and treated as if potentially
infectious.
,17=>7N-8.1(A;-7-.6173563.5
The test detects haemoglobin as low as 0.05 mg haemoglobin/g dry stool.
The detection limit in terms of Hb concentration in the transport medium is
0.1 µg/ml Hb.
A positive sample is typically detected within 2-3 minutes, but a negative
result must not be confirmed before 10 minutes have elapsed.
The test is specific for human haemoglobin subtypes HbA0, HbA2, HbF, HbS.
No cross reactivity with haemoglobin from sheep, turkey, pork, beef, goat,
horse, rabbit has been observed up to 1000 µg/ml each. No interference by
horse radish peroxidase has been observed up to 1000 µg/ml. Primate Hb
2
reacts cross.
The test reacts positive up to a haemoglobin concentration of 2000 µg/ml in
the transport medium.
Typical performance data can be found in the Verification Report, accessible
via:
www.human.de/data/gb/vr/1t-obti.pdf or
www.human-de.com/data/gb/vr/1t-obti.pdf
'10-63H1(QR30@(KS
Only one blue A>867>:( :381 QAS appears in the upper part of the rectangular
result window showing that the test has been carried out correctly and the
reagents were functioning.
,>5363H1(QR30@(B(-8<(TS
A second blue *156( :381 Q*S appearing in the lower part of the rectangular
result window, indicates a positive result for haemoglobin in the sample. Even
a weak line indicates a positive result (Fig. 3).
Different intensities between *156(Q*S and A>867>:(QAS lines may occur but do
not affect the interpretation of the results.
+8H-:3<(QR30@(FS
No control line or only the test line. Repeat the test with a new !)#-)%
carefully following this instruction.
U1=1718.15
1. Hochmeister M. N. et al., J. Forensic Sc. May, 597-602 (1999)
O3N36-63>85(-8<(+8617=1718.1
Samples from patients with bleedings for reasons like haemorrhoids or
menstruation should not be used. Alcohol in excess and therapy with aspirin,
indomethacine, phenylbutazone, corticosteroids and reserpine may cause
gastrointestinal bleeding. These medications should be discontinued by a
physician two days prior to testing.
No interference was observed with bilirubin (30 mg/dl), triglycerides
(1000 mg/dl), paracetamol (20 mg/dl), acetyl salicylic acid (20 mg/dl),
ascorbic acid (100 mg/dl) up to the indicated concentrations.
1T-OBTI
INF 2800901 GB
03-2004-15
!
Human Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 - D-65205 Wiesbaden - Germany
Telefon: +49 6122 9988 0 - Telefax: +49 6122 9988 100 - eMail: [email protected]