Immunochromatografic test for the determination of PCT (procalcitonin ...

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. The performance characteristics of this product have not been established.

104398

10602000 000

Immunochromatografic test for the determination of PCT (procalcitonin) in serum and plasma Article number: 106.025 (25 determinations) B·R·A·H·M·S and B·R·A·H·M·S PCT are registered trademarks of B·R·A·H·M·S Aktiengesellschaft. Other product names in this document are used for identification purposes; they may be trademarks and/or registered trademarks of their respective companies.

User leaflet B·R·A·H·M·S PCT-Q Date: 19.05.2004 (This version supersedes all earlier instruction manuals.) Protected by the following patents: USA N° 5 639 617; Europe N° 0 656 121, N° 0 880 702; Japan N° 3 257 796, N° 3 095 784; Australia N° 686 114; China N° ZL 93 1 18343X; Russia N° 2 137 130; South Africa N° 93/6042 Content changes versus previous version •

Umbrella brand adjustment

Contents of the kit It contains the following components in sufficient quantities for 25 individual determinations •

25 individual test sets

•

25 reference cards

• 1 user leaflet Each individual test set is sealed in a protective packaging and contains

Important notes As patient serum or plasma is to be regarded as being potentially infectious, the generally accepted precautionary measures and laboratory techniques must be strictly adhered to, when implementing the test. The EC safety data sheets specific to reagents according to the EC guideline 91/155/EEC may be obtained upon request. Please call our Customer Service Department on: + 49 (0)3302/883 300. The test and parts of the kit must be disposed of in accordance with the specifications of the local authorities.

Stability and storage conditions The B·R·A·H·M·S PCT-Q must be stored in the unopened individual test packaging at 2 – 30 °C. The expiry date indicated on the reverse of the individual test packaging is to be strictly observed.

•

1 individual test

Reference ranges

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1 disposable plastic pipette

•

1 dry bag

Data available up to now present the following picture with regard to the assessment of PCT concentrations:

Introduction The B·R·A·H·M·S PCT-Q is an immunochromatografic test for the semi-quantitative detection of PCT (procalcitonin), which is used for diagnosing and controlling the treatment of severe, bacterial infection and sepsis. B·R·A·H·M·S PCT-Q is a test system with an incubation period of only 30 minutes, which neither depends on apparatus, nor needs calibrating. The test uses a monoclonal mouse anti-catacalcin antibody conjugated with colloidal gold (tracer) and a polyclonal sheep anticalcitonin antibody (solid phase). After the patient sample (serum or plasma) has been applied to the test strip, the tracer binds to the PCT in the sample and a marked antigen antibody complex forms. This complex moves by means of capillarity through the test system and, in the process, passes through the area containing the test band. Here, the marked antigen antibody complex binds to the fixed anticalcitonin antibodies and forms a sandwich complex. At a PCT concentration ≥ 0.5 ng/ml, this sandwich complex can be seen as a reddish band. The colour intensity of the band is directly proportional to the PCT concentration of the sample and is related to the following PCT concentration ranges with the help of a reference card: < 0.5 ng/ml ≥ 0.5 ng/ml ≥ 2 ng/ml ≥ 10 ng/ml Non-bound tracer diffuses into the control band zone, where it is fixed and produces an intensely coloured red control band. The functional ability of the test system is checked by means of this control band. B·R·A·H·M·S Aktiengesellschaft B·R·A·H·M·S PCT-Q

Patients

PCT [ng/ml]

Normal persons

< 0.5

Chronic, inflammatory processes and autoimmune diseases

< 0.5

Viral infections

< 0.5

Minor to moderate bacterial, local infections

< 0.5

SIRS, polytrauma, burns

0.5 – 2

Severe, bacterial infections, sepsis, multi-organ failure

>2 (frequently 10 –100)

It is recommended that each laboratory establish its own reference ranges based on representative patient populations in order to test the validity of the data provided with commercial test kits. Therefore, the data given should be treated as orientational guidelines. Bibliography 1.

Meisner M: PCT, Procalcitonin – A new, innovative marker for severe infection and sepsis. Biochemical and clinical aspects. B·R·A·H·M·S Aktiengesellschaft (free of charge available at B·R·A·H·M·S Aktiengesellschaft)

2.

Karzai W, Oberhoffer M, Meier-Hellmann A, Reinhart K: Procalcitonin – A New Indicator of the Systemic Response to Severe Infections. Infection 1997; 25 (6): 329-334

3.

Hammer S, Meisner F, Dirschedl P, Höbel G, Fraunberger P, Meiser B, Reichardt B, Hammer C: Procalcitonin: a new marker for diagnosis of acute rejection and bacterial infection in patients after heart and lung transplantation. Transplant Immunology 1998, 6: 235-241

4.

Schröder J, Staubach K-H, Zabel P, Stüber F, Kremer B: Procalcitonin as a marker of severity in septic shock. Langenbecks Arch Surg 1999, 384: 33-38

Instruction manual (Version R07en)

D 11499 Page 1 of 2

The PCT concentration range is determined by comparing the colour intensity of the test band with the colour blocks of the reference card (see ill. 2).

Assay characteristics Precision and accuracy As a semi-quantitative test method, the B·R·A·H·M·S PCT-Q correlates closely to the B·R·A·H·M·S PCT LIA with regard to the individual concentration ranges. Due to individual differences in the readings, differences between B·R·A·H·M·S PCT-Q and LUMI-test® PCT are possible, particularly in the proximity of the PCT concentrations symbolised by the reference band. „High Dose Hook“ effect High PCT concentrations up to 4000 ng/ml have no affect on correct relating to the concentration ranges. Interference Haemoglobin values > 5 g/dl can restrict the reading accuracy and thus affect the test result. Severely haemolytic samples should not be measured with the B·R·A·H·M·S PCT-Q. Lipides or bilirubin have no effect on the measured result.

Handling of samples

Illustration 2

Serum or plasma samples which are not used for the assay within 4 hours after taking the blood sample must be frozen and stored at – 20 °C. Repeated freezing and thawing is to be avoided.

3.

Test procedure Note

Use a new individual test for each determination. Prior to commencing with the test, bring the temperature of all components to room temperature.

1.

Execution The individual test packaging is not to be opened until immediately prior to measuring the samples. Pipette 6 drops using the enclosed dropper pipette into the round cavity of the B·R·A·H·M·S PCT-Q. Fill pipette to at least the measuring line without any bubbles and hold slightly tilted when pipetting. Dispose of serum/plasma rests. Alternatively, a micropipette (200 µl) may also be used. Pipette 200 µl of serum/plasma into the round cavity. Incubate for 30 minutes at room temperature. Document the time when the test was begun on the reference card.

Note

2.

Recording and assessment After 30 minutes (max. 45 minutes), the PCT concentration range of the sample is determined. Firstly, the validity of the test is checked with the help of the clearly visible control band (see ill. 1).

Documentation and archiving To document the test result, the concentration range, which corresponds to the colour intensity of the test band, is marked with a cross on the reference card. The number of the batch (lot) used must also be entered on the reference card. To archive the test result, the fully completed reference card can be stuck in the patient file (peel off the covering paper from the reverse of the reference card, to uncover adhesive tape).

Particular notes

1.

A follow-up comparing a B·R·A·H·M·S PCT-Q test with one from the previous day is not permitted, as the colour may change (from red to violet) within a few hours. It may also happen, that a test which is negative after 30 minutes may turn slightly in colour after a few hours. The result obtained after 30 minutes reading time is valid in this case. Further information may be obtained from the Customer Service Department of B·R·A·H·M·S Aktiengesellschaft. Follow the manufacturer’s instructions carefully. Improper handling of the reagents may falsify the test results. B·R·A·H·M·S Aktiengesellschaft accepts no liability for faulty test results arising from improper storage, use or handling. The stability of the test must be observed.

B·R·A·H·M·S Service Address

B·R·A·H·M·S Aktiengesellschaft Neuendorfstrasse 25 D-16761 Hennigsdorf

Switchboard

Tel.: +49 (0)3302/883 0 Fax: +49 (0)3302/883 100 E-Mail: [email protected]

Orders

Tel.: +49 (0)3302/883 600, 700, 800 Fax: +49 (0)3302/883 666 E-Mail: [email protected]

Customer Service

Tel.: +49 (0)3302/883 300 Fax: +49 (0)3302/883 388 E-Mail: [email protected]

Internet

http://www.brahms.de http://www.procalcitonin.com http://www.kryptor.net

Illustration 1

A. No band or only test band visible: tests, which show no control band are not valid and may not be evaluated. B. Only control band visible: tests, which show only a control band are negatively valid. The PCT concentrations are < 0.5 ng/ml. C. Control and test band visible: tests, which show both a control band and a test band are positively valid.

B·R·A·H·M·S Aktiengesellschaft B·R·A·H·M·S PCT-Q

Instruction manual (Version R07en)

D 11499 Page 2 of 2