helic abt
DESCRIPTION
HELIC ABT instructionTRANSCRIPT
®
AMA Co Ltd
HELIC Ammonia Breath Test (HELIC АBT)
For in vitro diagnostic use
Store at –40°С to +45°С Upon Receipt
INSTRUCTIONS FOR USE
Emergo Europe AMA
VERSION 04, JULY 2011
Intended use and principle of operation
HELIC Ammonia Breath Test (HELIC ABT) is a ready-to-use test for qualitative detection of
Helicobacter pylori urease activity by changes in level of ammonia in breath air from patients with
suspected Helicobacter pylori infection.
The test is applied by gastroenterologists, general practitioners, by staff of primary health centers
and dispensaries and allows to implement Near Patient Testings (NPT) in any place and situation.
Packaging and size of the HELIC ABT make the test easy to transport in regions with various
climate conditions.
Sensitive composition inside the indicator tube allows the Helicobacter pylori infection to be
detected without using complicated equipment or radioactive isotope markers. The test’s
sensitivity is 87%, specificity is 91%. The procedure of analysis lasts about 15 minutes. The test
can also be recommended for children and pregnant women without any special precautions.
The method
The test is based on kinetic registration of ammonia concentration in patient`s breath air after a
portion of unlabelled urea 12
C was taken. The indicator tube changes color from yellow or
orange to blue or violet due to presence of ammonia, thus allowing to evaluate the readout
during the test.
The analysis consists of 2 parts. In Part I the basal level is detected. In Part II a portion of urea
(solution of 0,5 g in 50 ml of water) is taken and the load level is detected. After that the first
and second levels are compared and the conclusion regarding the Helicobacter pylori infection
presence is made.
Equipment and attendant materials
plastic indicator tube with the indicator composition inside and both ends sealed;
suction pump;
hose to connect the indicator tube and the suction pump;
urea load – 0,5 g for 1 analysis;
60-80 ml pure still water;
plastic cup with a spoon;
stopwatch;
scale.
Preparations before the test Read the complete assay procedure before starting.
In order to fulfill HELIC ABT correctly, patient should meet the following requirements:
the test is to be performed on an empty stomach. If the test is to be carried out in the
morning, the patient should fast overnight and not eat breakfast. If the patient has
eaten a meal then it will be necessary to fast for 8 - 10 hours prior to the test.
no antibiotics or antisecretory agents for at least 2 weeks before the test, no
antiinflammation agents and no antiacides for at least 24 hours (better 2-3 days), no
resolvents and analgesics for 5 days;
no strong alcohol for 3 days before the test;
no legumes (such as peas, kidney beans, lentil, soy) for at least 24 hours before the test;
no chewing gum for at least 3 hours before the test.
It is also recommended that a patient didn’t smoke for 2-3 hours before the test.
Patient should have his/her teeth brushed before the test.
Test procedure
Part I
Step 1. Open the indicator tube by cutting the edges off. Connect the tube to the hose,
then connect the hose to the suction pump.
Step 2. Ask the patient to take the tube into his/her mouth cavity so that it didn’t
contact with anything. Switch the pump on. Aspirate the breath air during the
period indicated at the label on the pump (6 or 7 minutes).
Attention: The saliva must not get inside the tube! Patient should keep his/her
mouth slightly open throughout the whole analysis. Patient must not blow into the
tube. If saliva accumulates in the oral cavity, the patient can take the inducator
tube out, swallow, then place the tube back.
Please note that if saliva gets inside the indicator tube, it immediately changes
color very dark. If you notice such effect, abort the test and start over with
another indicator tube.
By the end of the aspiration period the indicator tube might change it’s color to blue.
Disconnect the tube and measure the column that has changed color using the scale (in
millimeters) and write this figure down. This is the basal level value. This value might
also be zero if the tube hasn`t changed it’s color.
Part II
Step 3. Ask the patient to take 0,5 g urea dissolved in 50 ml water. After he/she drinks
it, ask the patient to rinse mouth cavity with water.
Step 4. Turn the indicator tube the other side and connect it to the hose.
Step 5. Wait for 2 minutes and start the second aspiration, as described in step 2.
Attention: The saliva must not get inside the tube! Patient should keep his/her mouth
slightly open throughout the whole analysis. Patient must not blow into the tube. If saliva
accumulates in the oral cavity, the patient can take the indicator tube out, swallow, then
place the tube back.
Please note that if saliva gets inside the indicator tube, it immediately changes color to
very dark. If you notice such effect on this stage of the test, abort it, wait for at least 40
minutes and start over from step 3 using another indicator tube.
Step 6. Compare the basal level value with the load level value. Count the delta by
distracting the basal level value from the load level value.
Results Step 7. See the cut-off value (2 or 3 mm) on the label of the immediate container
(plastic bag that contains the indicator tubes) and compare it to the delta value:
if the delta exceeds the cut-off value, the test is positive;
if the delta is less than the cut-off value, the test is negative.
Limitations and precautions
False negative results may occur if:
antibiotics have been taken 2-4 weeks prior to the examination;
acid inhibiting drugs (PPI or H2-blockers) have been taken prior to the
examination.
Negative result does not rule out the possibility of Helicobacter pylori infection. If
clinical signs are suggestive of Helicobacter pylori infection, retest with a new sample
or an alternate method.
False positive results may occur due to urease associated with other gastric spiral
organisms observed in humans such as Helicobacter heilmannii.
As with any diagnostic procedure the HELIC ABT results must be interpreted in the
light of the patient’s clinical picture and any other information available to the
physician.
For in vitro diagnostic use only. The urea solution is taken orally as part of the
diagnostic procedure.
Storage and stability Store the HELIC ABT at the temperature from –40°С to +45°С in the dark place in the
manufacturer pack. Keep away from the ammonia vapor, direct sunlight and moisture. The
storage place must be protected from mechanical action (friction, pressure, strokes).
Warranty The Manufacturer shall remedy all defects discovered in any Product (the “Defective
Product”) that result from unsuitable materials or negligent workmanship and which prevent
the mechanical functioning or intended use of the Products including, but not limited to, the
functions specified in the Manufacturer’s specifications for the Products.
Any warranty will, however, be deemed as void if fault is found to have been caused by
maltreatment, misuse, accidental damage, incorrect storage or use of the product for operations
outside their specified limitation or outside their specifications, contrary to the instructions
given in the instruction manual.
The period of this warranty for the Distributor is defined in the instruction manual of the
Products and will commence from the date the relevant Product is shipped by the
Manufacturer.
Ordering information
Distributor: Gapro Medica, Closed JSC, R. Kalantos str.183/14, LT-52326 Kaunas,
Lithuania. Tel: (370) 601 70034 E-mail: [email protected] Web:
www.gapromedica.com
Manufacturer: AMA Co Ltd, 17 line of Vasilievsky Island, 4-6, 199034, St-Petersburg,
Russia. Tel: (007) 812 321-7501 Fax: (007) 812 380-7699 E-mail: [email protected] Web:
www.amamed.ru
Authorized Representative in Europe (Regulatory affairs only): Emergo Europe
Molenstraat 15, 2513 BH The Hague, The Netherlands Tel: (31) (0) 70 345-8570 Fax:
(31) (0) 70 346-7299
Explanation of the symbols, used in labels
AMA Co Ltd, 17 line of
Vasilievsky Island, 4-6, 199034,
Saint-Petersburg, Russia
– 40°…+45°C Temperature
limitation. Storage at –40°С …
+45°С and use at
+15°…+45°С.
Emergo Europe
Molenstraat 15, 2513 BH The
Hague, The Netherlands Do not reuse
Use by
Consult instructions for use
Batch code
In vitro diagnostic medical
device
Date of manufacture
Contents sufficient for n tests
Cut-off Value to compare test results, see
Part II of Test procedure
Aspiration
period
Time of aspiration, see Part I of
Test procedure