user manual Geratherm chlamydia check
Contents
1. Geratherm chlamydia check Chlamydia rapid test for self testing KIT CONTENTS sample bottle with buffer swab foil pack with test cassette and desiccant instructions for use Please also have a watch or clock to hand test cassette swab sample bottle with buffer result field sample field S IMPORTANT NOTE Please follow the instructions for use Do not use after expiry date Store test components between 4 and 28 C Do not take the test cassette apart For external use only Keep the test out of reach of children In vitro diagnostic device for personal use Open the foil pouch just before running the test Buffer is corrosive before mixing Use test buffer solution bottle and swab only once This test is suitable for taking cell samples from the neck of the uterus and is thus only for use by women In the event of infection it is recom mended that your sexual partner also takes a test and undergoes treat ment As a precaution please wash your hands after performing the test This test is not suitable for use during pregnancy Do not use this test during menstruation and for three days after the end of your period or if you have a urinary tract infection Only use the swab provided and before use make sure the packaging is undamaged Do not make any important medical decisions without consulting your doctor After use the test components may be discarded with your ordinary household waste T2. hose parts of the test materials which are of animal origin e g antibod ies are potentially infectious substances but do not comprise any risk provided all test components are used according to the instructions INFORMATIONEN This test serves to detect Chlamydia trachomatis one of the three known types of Chlamydia Chlamydia infection is the most frequently occurring sexually transmitted disease In Germany alone the number of new infec tions is estimated at between 300 000 and 500 000 per year Younger adults between age 15 and 25 those who frequently change sexual partners the sexual partners of those infected even those without symptoms who are unaware that they carry the infection as well as newborn babies of infected mothers are the most frequently affected Infections without sexual contact e g from swimming pools are rare but not impossible Chlamydia trachomatis infections frequently have no symptoms However they may also lead to complaints such as eye infections arthritis and uri nary tract infections In addition untreated infection frequently leads to infer tility as well as increasing the risk of ectopic pregnancy and preterm births In developing countries Chlamydia trachomatis infection is the most common cause of blindness among newborns It is particularly important to treat Chlamydia infections in pregnancy Around 50 of infected mothers pass the infection on to their newborns Common complications amo
3. ng newborns include conjunctivitis and pneumonia Compared with the PCR method in a clinical performance evaluation with 596 participants this test achieved diagnostic sensitivity of 85 7 and diag nostic specificity of 98 3 A lay study was also conducted with 56 subjects Of these 56 54 interpreted the result correctly TAKING A SAMPLE USING THE SWAB Before taking a sample avoid urinating for at least one hour since oth erwise an incorrect result may be yielded Perform the test in a location where you will be undisturbed Take the swab out of the pack If the pack aging is damaged please do not use the swab and instead contact the manufacturer 1 Select a comfortable position such as one you would adopt for inserting a tampon Carefully insert the swab into your vagina as far as the neck of the womb top end of your vagina Rotate the swab r evenly for about 30 seconds and then slowly with draw the swab 2 There is purposely only a small quantity of solution in the sample bottle 3 Dip the swab containing the sample right into the bottle so that it touches the bottom of the sample bottle Rotate the swab in the solution and squeeze it out several times against the side wall of the bottle in order to ensure that the sample is mixed thoroughly with the buffer solution 4 Wait 5 minutes If you wait too long or not long enough this will distort the test result Dur ing the waiting time the swab mus
4. rforming the test Please retain all the test materials and contact the manufacturer If you wait more than 20 minutes it will no longer be possible to eval uate the test reliably Please therefore dispose of the test cassette once you have finished interpreting the result at the correct time QUESTIONS AND ANSWERS What should do if my test result is positive Please see your doctor in order to discuss the result Please take these instructions for use with you to your appointment so that your doctor is able to gain a clearer picture of the test you have performed What should do if my test result is negative A negative test result means that you are highly unlikely to have a Chlamydia trachomatis infection but it is still recommended that you are regularly checked by your doctor SYMBOLS Attention see instructions RVA Test per kit Manufacturer for use For in vitro diagnostic Use by Do not reuse use only Re Store between ae 4 C and 28 C Lot number whe corrosive Geratherm Medical AG FahrenheitstraBe 1 98716 Geschwenda Germany C 0197 Swab STERILE Puritan Medical Products Co 31 School Street c 0086 Guilford USA wil wal
5. t remain in the bottle PERFORMING THE TEST You should now prepare the foil pack In just 15 minutes you will learn whether or not you have a Chlamydia trachomatis infection 5 Close sample bottle and shake it gently one more time Hold the sample bottle with the cap upwards and snap off the tip of the cap 6 Now as shown in the illustration place 2 drops of the solution onto the sample field S on the test cassette Please make sure that no liquid falls di rectly onto the reaction field 7 Now wait 15 minutes If you wait for longer than 20 minutes it will no longer be possible to inter pret the result reliably READING AND INTERPRETING THE RESULT A sample is considered positive if within the reaction c time of 15 minutes two purple lines appear in the reaction zone of the cassette at C and T even if the coloured T line at T is very faint A positive result can often be identi Ll fied before the end of the 15 minute reaction time cC Aresult is considered negative if there is only one purple T line at C A negative result can only be established with certainty at the very end of the 15 minute reaction time A result is considered invalid if no purple line appears T or there is only a line at T in the test field or the entire test field turns purple Possible reasons for an invalid result may be a damaged foil or swab pack incorrect storage or an error in pe
Download Pdf Manuals
Related Search