FAQs : SD BIOLINE Syphilis 3.0

Transcription

1 FAQs : SD BIOLINE Syphilis 3.0 Table of contents Case 1. Overflow phenomenon - Possible cause - - Confirmatory test of migration pattern Case 2. Slow or non migration - Possible cause - Technical Support Team Sean Kim

2 Case 1. Overflow phenomenon Definition of Overflow phenomenon: Assay diluents flow on the membrane because too m uch assay diluents add in the sample well and then as say diluents can t adequately absorb in the sample pa d. This phenomenon can cause horizontal line and severe reddish background on the membrane and can hardly ever read the control line and test line. Figure. Overflow Possible cause : Add too much assay diluents If adding above 5 drops in the sample well mistakenly, it is possible that overflow phenomenon could occur. Insert sheet of SD BIOLINE Syphilis 3.0 states the whole test procedure. This instruction must be followed exactly to get accurate results. (Below is test procedure.) Test procedure in SD BIOLINE Syphilis Remove the test device from the foil pouch 2. Transfer 10μl of serum or plasma (or 20μl of whole blood) to the sample well (S) 3. And then add 3~4 drops of assay diluents and start the timer. 4. Interpret test results at 5 ~ 20 minutes

3 Case 1. Overflow phenomenon Confirmatory test for verifying migration pattern in SD BIOLINE Syphilis 3.0 Test objective : To verify migration pattern depending on assay diluents volume Test procedure : Add different assay diluents volume / Other procedures are all same. Test result : Overflow phenomenon could not found in 3 drops, 4drops, 5drops of test result s. 1 overflow phenomenon occurred in 6 drops, 2 overflow phenomenon occurr ed in 7 drops. Although test result was normal in 5 drops, there is a risk of overflow phenomenon when adding 5 drops. Table. Migration pattern Test product : SD BIOLINE Syphilis 3.0 #1 #2 #3 #4 #5 3 drops 4 drops Assay diluents volume 5 drops 6 drops Overflow 7 drops : We kindly recommend that you should apply 3~4 drops of assay diluents after the specimen was added in the sample well.

4 Case 2. Slow or non migration Definition of slow or non migration: Specimen and assay diluents do not flow adequately on the membrane due to some factors. Figure. Migration fault Possible 1 : Too long interval between adding specimens and assay diluents If the assay diluents drop lately after sample dropped, incompleteness of migration can be shown. Recommendation is that the assay diluents drop immediately after specimen is dropped. Possible 2 : Using abnormal specimens If the specimen is too sticky, it is p ossible that slow migration or non migration can occur. Sticky specim ens can block the pores of membra ne and this phenomenon can interf eres with migration of assay diluent s. You need to applying the specim en in the sample well after mixin g sufficiently for a short time as using the vortex apparatus.

5 Case 2. Slow or non migration Possible 3 : Improper storage of kit or test at very low humidity Because of improper kit storage be low 2 or above 30, or in case t hat you perform the test at very low humidity below 30% RH, incomplet eness of migration can be shown. You need to adjust humidity ove r 30% RH and store the kit at tem perature between 2 ~ 30 proper ly. Possible 4 : Test kit is very sensitive to humidity Testing delayed after opening the p ouch can cause incompleteness of migration because the rapid test kit is very sensitive to humidity. You need to remove the test strip/device from the foil pouch and use it as soon as possible. T he best result will be obtained if t he specimen is performed within 30 minutes after opening the pou ch. Possible 5 : Inadequate adhesion between nitrocellulose membrane and gold -conjugate pad As look into structure of our produ ct, gold-conjugate pad is located on the nitrocellulose membrane, these material may be detached from me mbrane during the transportation or some unknown factor including pro ducing error. This case can cause i nvalid result although the user perfo rmed the test properly. We kindly recommend that you should perform re-test.

6 Thank you for your attention.