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
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 12C 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: firstname.lastname@example.org 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@example.com 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
Consult instructions for use
In vitro diagnostic medical device
Date of manufacture
Contents sufficient for n tests
Value to compare test results, see Part II of Test procedure
Aspiration Time of aspiration, see Part I of period Test procedure