User Manual - Diagnostik Nord
Contents
1. Toxicology BOR K20 Tick rapid test for Borrelia The rapid test for direct borrelia detection in ticks INTENDED USE The Diagnostik Nord Borrelia antigen test BOR K20 directly detects Borrelia B garinii B afzellii and B burgdorferi sensu stricto the Pathogens of Lyme borreliosis in the tick The lyme disease is a serious illness that is transmitted by ticks The causative agent of Lyme disease Borrelia burgdorferi sensu lato is a gram negative spiral sshaped and mobile bacterium spirochete Globally at least 13 Genospecies belong to the Borrelia burgdor feri sensu lato complex The 3 main species B burgdorferi sensu stricto BSS B garinii Bg and B afzellii Ba are also human pathogens Borrelia are transmitted by ticks of the genus Ixodes ricinus Ixodes Ricinus In Europe the prevalence of Borrelia in ticks is regionally different 5 35 If a tick has already engorged itself with blood it cannot be excluded as the potential infecting agent and the tick should be examined for borrelia A negative tick does not excclude an infection with borrelia A Borrelia infection in humans can only be diagnosed by a physician the test is only used for the detection of Borrelia in the ticks PLEASE NOTE BEFORE USE e Use a new test cassette for every individual test and tick tube e Only for one time usage e Use only the original test components provided in the kit Only for one time usage e Use the test c2. 12 2013 of spiked ticks in the PCR compared with the Diagnostik Nord Borrelia antigen test revealed that Borrelia of the following species were detected in both test systems B burgdorferi sensu stricto B afzelii and B spielmanii LITERATURE J Eckert K T Friedhoff H Zahner P Deplazes Lehrbuch Der Parasitologie f r die Tiermedizin Enke Verlag 2 vollst berarb Aufl 2008 W Luttmann K Bratke M K pper D Myrtek Der Experimenta tor Immunologie Spektrum Akademischer Verlag S 110 f 3 Auflage 2009
3. assette within 60 minutes after opening the pouch e The test cassette must be in a horizontal position on a smooth surface under while the test is performed e Note the amount of reagen depends on the size of the tick needed An incorrect number of drops or too small drops may lead to false test results e Consider the test results as invalid after the specified read out time e Do not use the test after the expiration date printed on the pouch only for one time usage FOR USE IN TICKS e The tick must be crushed thoroughly the borrelia is located in the tick s colon e Try to keep the sample field clear of any tick particles e Only use the wooden stick for the purpose described here e Immediately take the wooden stick out of the reagent mixture after crushing the tick STORAGE OF THE TESTKITS The Diagnostik Nord test kit should be stored between 2 30 C COMPONENTS OF THE TEST KIT Reaction field Tick tube Reagent Bottle of reagent wooden Test cassette Pipette stick 0cm 1 2 3 mpi Small to medium sized tick max 8 mm Diacnostik Norp IHR PARTNER FUR IN VITRO DIAGNOSTIKA TEST PROCEDURE Carefully remove the tick and make sure that the head is removed as well Tick pliers are recommended After the tick has been removed and before beginning the test you can store the tick in the supplied sample tube Testing the tick directly after removal yields the best res
4. gstr 97 Fax 49 0 385 208409 29 s E field of the test cassette A red line in the T region T of the re 19053 Schwerin E Mail info diagnostiknord de action field indicates a positive test result Borrelia antigen was Germany Internet www diagnostik nord de T T detected in the tick The less Borrelia antigens are present the weaker the T line Also a faint test line is considered as a positive test result The second red line in the C region C indicates the control line which indicates the correct performance of the test The C line is not a reference line and may have a different line intensity than the T Line NEGATIVE Negative test result Only the control line appears C T INVALID Invalid test result If no control line appears after the test is conducted the test C is invalid In this case it is likely that the test was not properly conducted or that the expiration date had already lapsed If T this occurs a new test must be conducted For the case of a strong background staining after 10 minutes the test cassette can be hold under cold running water for one minute to wash the background color away the test result is visible TEST PERFORMANCE Sensitivity comparison system study 2009 and 2013 2014 Polymerase Chain Reaction PCR Sensitivity Specificity PPW NPW TTP 86 67 Diagnasiie Nora 92 86 95 83 95 35 Borrelia antigen test 97 87 Specificity An analysis Comparison study 20
5. operly If large particles have gotten onto the sample field you can also press down on the sample field with the tip of the pipette causing the liquid to run again or add another drop of reagent liquid onto the sample field The results of the test can be read after 10 minutes The maximum read out time is 20 Large ticks 1 Place the engorged tick in the tick tube 2 Crush the tick with the supplied wooden stick sharp side so that the tick juice excre tes and the colon is crushed Then remove the wooden stick 3 Take up the tick juice with the pipette Ensure that you do not take up any tick particles 4 Add a drop of tick juice on the sample field of the test set and let it soak for a few seconds 5 Add 2 drops of reagent liquid The liquid starts to slowly run across the test strip Application tips if the liquid does not run properly If large particles have gotten onto the sample field you can also press down on the sample field with the tip of the pipette causing the liquid to run again or add another drop of reagent liquid onto the sample field FR Keep dry catalogue number The results of the test can be read after 10 minutes The maximum read Rev 06 10 2015 JM replace 08 07 2015 out time is 20 PRODUCER TEST RESULT POSITIVE Positive test result Diagnostik Nord GmbH Telefon 49 0 385 208409 0 Read for a positive result two red lines appear in the reaction Mecklenbur
6. ults A second point is the crushing procedure for an optimal testing The borrelia to be verified is located in the tick s colon Only a thorough crushing of the colon can yield an optimal result An optimal test execution depends on the size of the tick If a small to medium sized tick is to be tested lt 8 mm test procedure Small to medium sized ticks should be followed If the tick to be tested is a large heavily engorged tick the body of the tick shows a significant size increase gt 8 mm only one drop of the tick juice is tested according to test procedure Large ticks should be followed Small to medium sized ticks lt 8 mm 1 Place the tick in the sample tube and fill the sample tube with 3 drops of reagent liquid 2 Crush the tick with the wooden stick until the liquid becomes discolored Use the sharp and dull side of the wooden stick for this purpose Then remove the wooden stick 3 Take up the tick reagent mixture with the pipette Ensure that you do not take up any tick particles 4 Place the tick reagent mixture on the sample field of the test set Ensure that you do not take up any tick particles with the pipette as these could clog up the sample field 5 The liquid starts to run across the test strip Note it makes little sense to test very small ticks that have not yet been drawn or to test nymphs since the destruction of the intestine is difficult Application tips if the liquid does not run pr
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