AMA Co Ltd

Helicobacter pylori

AMA RAPID UREASE TEST

Express-test for Helicobacter pylori urease activity in

Biopsy Specimen

For in vitro diagnostic use

Store at 15-50oC Upon Receipt

INSTRUCTIONS FOR USE

Emergo Europe AMA

EDITION 04, JULY, 2011

Intended use and principle of operation

AMA Rapid Urease Test is a ready-to-use test for qualitative detection of Helicobacter pylori

urease activity in biopsy specimen obtained by gastroscopy from patients with suspected

Helicobacter pylori infection. The test is applied by endoscopists and allows to implement

Near Patient Testings (NPT) as well as at the laboratory.

The biopsy specimens taken from antrum, body of stomach or duodenal cap could be the

biomaterial for the testing.

Put the biopsy specimen on the surface of the indicative disc and see the color change.

Warnings and precautions

For in vitro diagnostic use.

CAUTION: Handle biopsy specimens as potential biohazardous material.

Design of the device

1, 3, 10 or 21 indicator discs, fixed on the rectangular-shaped carrying base and hermetically

protected by the plastic cover.

Preparation before the testing

Read the complete assay procedure before starting.

Put on the gloves.

Tear off the plastic cover to access the indicator disc. Make sure that the color of the indicator

disc is yellow.

Put the carrying base on the flat surface.

Test procedure

With the forceps put the biopsy specimen on the indicator disc, switch on stopwatch.

Three minutes later replace the biopsy specimen from the indicator disc.

Immediately assess the color change of the spot on the indicator disc.

Results

If the color of the spot is blue, the test is positive.

If the color of the spot remains yellow, the test is negative.

The higher the urease activity of Helicobacter pylori is, the quicker does the spot appear and

the bigger it is. The result must not be taken into consideration if the biopsy specimen is

replaced from the indicator disc later than three minutes after it has been put on it.

Limitations

False negative results may occur if:

• H. pylori inhibiting 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.

As with any diagnostic procedure the AMA Rapid Urease Test results must be interpreted in

the light of the patient’s clinical presentation and any other information available to the

physician.

Storage and stability

Store the AMA Rapid Urease Test at the temperature from +15°С to +50°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). After

the plastic cover was torn off, the test must be used within 2 weeks.

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

Association of Medicine and Analytics

17 line of Vasilievsky Island, 4-6, 199034, Saint-Petersburg, RUSSIA

Tel: +7-812-380-7699, +7-812-321-7501 Fax: +7-812-321-7501

E-mail: info@amamed.ru 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

Association of Medicine and Analytics

17 line of Vasilievsky Island, 4-6, 199034, Saint-Petersburg, Russia

Emergo Europe

Molenstraat 15, 2513 BH The Hague, The Netherlands

Use by

Batch code

Date of manufacture

Contents sufficient for n tests

Do not reuse

Consult instructions for use

In vitro diagnostic medical device

+15…+60°C Temperature limitation. Storage at +15…+50°С and use

at +15…+60°С.