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    Syphilis Card

    Uploaded by

    Rakim Mikar

    Copyright:

    © All Rights Reserved
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    BEACON DIAGNOSTICS PVT. LTD SYPHILIS (Card) (Immuno Chromatography Method) INTENDED USE : ‘This Syphilis Testis intended for “In vitro” qualitative determination of Treponema antibodies (IgA.lgM1gG) produced against Treponema pallidum antigen (17KDa, 15 KDa, 47KDa) in human serumiplasma. PRINCIPLE: ‘Syphilis Rapid Test isa qualitative membrane device based immunoassay for the detection of TP antibodies (IgA, IgM, IgG) in serum or plasma. In this procedure, recombinant syphils antigen (17KDa, 15KDa, 47KDa) is immobilized in the test ine region of the device. After the specimen is added to the specimen well ofthe device, it reacts with syphilis antigen coated parties in the test. This mixture migrates chromatographicaly along the length of the test strip and interacts withthe immobilized Syphilis antigen. The double antigen test format can detect IgA, lgG and IgM in specimens. If the specimen contains TP antibodies a coloured line will appear inthe test line region, indicating a positive result. Ifthe specimen does not contain TP antibodies, a coloured line will Rot appear in test region, indicating a negative result. To serve ‘as a procedural contro, a colored line will always appear in the ‘control line region, indicating that proper volume of specimen has been added and membrane wicking has occured. SPECIMEN COLLECTION & PREPARATION : Use Fresh serum, collec blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot. Use fresh serum for testing. ‘TEST PROCEDURE : 1. Remove the test device from its protective pouch (bring the device to room temperature before opening the pouch to ‘avoid condensation of moisture on the membrane). Label the Device with patient or control identifications and use the device as soon as possible. 2. Using the dropper provided put 2-3 drops of serum sample into the sample well. Avoid overflowing. 3. Wait for 5-20 minutes and read resulfs. itis important that the background is clear before the result is read. Important note : Do not read results after 30 min’s PRECAUTION 41) Forin vitro diagnostic use only. 2) Do not use test kit beyond expiry date. 3) The test device should not be reused 4) Keep out ofthe reach of children. 8) Do not freeze the kit. 6) Specimen with extremely high concentrations of red blood cells, fibrin should be recentrifuged before use STORAGE AND STABILITY: “The test kit can be stored at temperatures between 4 to 30C in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat. BEACON INTERPRETATION OF RESULTS : Negative : Only one coloured band appears on the control (Cyregion. No apparent band on the test (T) region. Positive : in addition to a pink coloured contro (C) band, a distinct pink coloured band will also appear inthe test (T) region. Invalid : A total absence of colour in both regions or no ‘coloured line on the control (C) region is an indication of [procedure error andlor the test reagent deterioration. Repeat the test with a new kit LIMITATIONS : 1.As with all diagnostic tests, all results must be considered with other clinical information available to the physician, A definite clinical diagnosis should only be made by the physician afterall clinical and laboratory findings have been evaluated, 2:This test kts forthe detection of TP antibodies in serum ‘specimen. This testis for in vitro diagnostic use only. Neither the quantitative value nor the rate of increase in TP antibodies, can be determined by this qualitative test. ‘3.This kt will only indicate the presence of TP antibodies in the ‘specimen and should not be used as the sole criteria forthe diagnosis of TP infection. 4. Ifthe test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possiblity of TP infection. ‘5. Positive results should be confirmed by other confirmatory tests, Code No. Pack size 106 s0T Baas 424, NEW GIDC, KABILPORE, NAVSARI - 396 424. INDIA SYPHILIS TEST (Strip) (Immuno Chromatography Method) INTENDE USE: One Step Ant-Syphils Strip Test isa rapid and immunochromatographis procedure for the qualitative detection of Treponemal antibodies (IgA, IgM, IgG) Generated against Treponema pallidum antigens (17KDa, 15KDa, 47KDa) in human serum/plasma with high sensitivity and spect. Test resus are read visualy without any instrument. Purifed recombinant ‘syphilis antigens are employed to identify anti-Syphilis antibodies specticaly and also used in detection "of eee ‘syphilis. Strip test for detection of Syphilis in PRINCIPLE: ‘Syphilis Rapid Test strip is a qualitative membrane based immunoassay for the detection of TP antibodies (IgA, IgM, IgG) in Serum or Plasma .in this procedure, recombinant syphilis antigen (17KDa, 1SKDa, 47KDa) is immobilized in the test line region ofthe strip. Dip the strip in the specimen; itreacts with syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test strip and interacts withthe immobilized ‘Syphilis antigen. The double antigen test format can detect [gA, IgG and IgM in specimens. Ifthe specimen contains ‘TP antibodies a colored line will appear inthe test line region, indicating a positive result. I the specimen does not contain TP antibodies, a colored line will nt appear in this region, indicating a negative result. To serve as a procedural control, a colored line will aways appear in the Control line region, indicating that proper volume of ‘specimen has been taken and membrane wicking has ‘occurred, CONTENTS: ‘Syphilis Test Strip, ‘SPECIMEN COLLECTION & PREPARATION : Use Fresh Serum, collect blood into a container without anticoagulant. Allow the blood to clot and separate the ‘serum from the clot. Use the Fresh serum for testing. TEST PROCEDURE : 41. When you are ready to begin testing, open the sealed ‘pouch by tearing along the notch. Remove the test strip from the pouch and use it as soon as possible. 2. Following the illustration dip the test strip with the arrow ‘side pointing down into the vessel of serum for about 10 ‘seconds. Donot immerse it past the marked line. Take the strip out and lay it on a clean, dry and non absorbant surface. 3, Wait for 5 -20 mins. And read results, It is important that the background is clear before the results are read. NoTI Do not read results after 30 minutes. PRECAUTIONS: 41) For in vitro diagnostic use only. 2) Do not use test kit beyond expiry date. 3). The test device should not be reused. 4) Keep out of the reach of children. 5) Do not freeze the Kits. 6) Specimen with extremely high concentrations of red blood cells, ib rin should be recentrifuged before BEACON DIAGNOSTICS PVT. LTD 1007 100, Wo] Sd 424, NeW @be, KABIL PORE, NAVSARI "390 428 TN BEACON STORAGE AND STABILITY : ‘The test kt can be stored at temperatures between 4 to 30° C in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat. INTERPRETATION OF RESULTS : Negative : Oniy one colored band appears on the contol (©) region. No apparent band onthe test (7) region. Positive : In addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region. Invalid : A total absence of color in both regions or no colored line appears on the control (C) region is an indication of [procedure error and / or the test reagent deterioration. Repeat the test with a new kit NEGATIVE. PosiTive. LIMITATIONS : 1. As with all diagnostic tess, all results must be considered with Other clinical information available to the physician. A definite clinical diagnosis should only be made by the physician afterall clinical and laboratory findings have been evaluated, 2. This test kits for the detection of TP antibodies in serum ‘specimens testis for in vitro diagnostic use only. Neither the quantitative value nor the rate of increase in TP antibodies can bbe determined by this qualitative test. 3. This kit will only indicate the presence of TP antibodies in the s pecimen and should not be used as the sole criteria for the diagnosiso {TP infection. 4. Ifthe test result is negative and clinical symptoms persist, ‘additional testing using other clinical methods is recommended. ‘A. negative result does not at any time prectude the possibilty of TP infection. 5. Positive result should be confirmed by other confirmatory tests. SENSITIVITY & SPECIFICITY : To establish the sensitivity and specificity of One-step Syphilis test kit relative to other rates of qualitative serum Syphilis tests, 305 clinic samples were studied. Another commercially available Qualitative test kit was used to compare with Beacon Diagnostic (One-step Syphilis test kit for relative sensitivity and specificity in 305 serum samples. Only 1 sample was discordant, the agreement is 99.67%. REFERENCES : 1) Claire FM. Complete genome sequence of Treponema paalidum, s y philis spirochete, Science 1998; 281 July 375-381. 2) Center for Disease Control. Recommendations for diagnosis ‘and tr eating Syphilis in HIV - infected patients, MMWR Morb. MortalWkly Rep. 1998; 37:601. CodeNo. Pack Size BEACON DIAGNOSTICS PVT. LTD ASO TEST KIT INTENDED USE = ‘This diagnostic reagent kits intended forthe invite determination of ‘Antistreptlysn - © activity in serum by sid agglutination method, PRINCIPLE : ‘The ASO Latex est contain polystyrene latex particles, coated with purfied and stabiized Steptolysn-O (Antigen) which reacts wit its corresponding Antisteptolysin-O (Antibody) inthe test ‘sample resulting inthe agglutination of atx parts. CLINICAL SIGNIFICANCE : Group A Streptococ’ produces soluble and oxygen labile hemolysin ‘known as strptolysin 0”. This has lethal flocs onthe human being ‘and especially toxic action to heart muscle. The pathological changes othe heart are proliferative where it produces Valvular cendocardiis, myocandiis and fbrinous pericarditis. when the joints ‘are affected it produces migratory non purulent artis. The heart Involvement is seen commenly in pediatric age group whereas joints lnvolvoment is observed mostly in adult patonts. Contents : Rroag Foagent 3: Negative Control SAMPLE : (Only serum should be used fr testing. Do not heat or inactivate the test or contol serum. In case of delay in testing store the sample at 2°-8°C. ‘STORAGE AND STABILITY ‘Al Reagents ae stable at 2°-8°C til the expiry date mentioned on the ‘abel. PROCEDURE ‘Qualitative Side Test: ‘Alow al reagents as wel as the sample to reach room temperature. 1. Using disposable plastic dropper place one drop of test specimen In led area of the side provided inthe kt. 2. Ad one drop of ASO latex ation to the above drop and mix wo wth dsposable applicator sok. 3. Rock the side gonly back and forth fortwo minutes and examine for ‘agglutination, De not examine beyond two minutes. For Positive & Negative Contos follow the same Procedures as, ‘mentioned above by taking cotrl serum trom respective vials. ‘SEMI QUANTITATIVE TEST : 4. Dut the serum Seraly in tho rato of 1:2, 124, 1:8, 1:16. 1:32 sing normal saline. 2. Place one drop of clued sample using plastic dropper in each rel of lass sido 3. Add one drop of latoxreagentin each ofthese circles. mix well with applicator stick. 4. Rock the side gnty back and forth fortwo minutos and examine for agglutination ‘TEST RESULT! Qualitative Method. 1 Agglutinaton i a postive test result and indicate the presence ‘of detectable Ant Stropolysin-O antibody in serum. 2.No agglutination is @ negative test result and indicates the ‘absence of detectable ant stoptlysin-O antbody in serum. ‘SEMI QUANTITATIVE METHOD: ‘Aggltnation in the highest serum dition corresponds to the ‘approximate amount of ASO Concentration in 1 /mlin test serum, Concentration of ASO can be cated as fellows ‘ASO (IU/ml) = Tire xASO Sons (1 / mi) Where ASO Sensi = 200 1 md Tito = Highest ition showing oar cut agglutination NOTES: 1. Posltve and Negative Contos are ready to use. 2. Contaminated sera anda longer reaction tine may lado {alse Posive resus. 3. Improper mixing and drying of reagents may load to eroneous results. LIMITATIONS: ‘An elovatod ASO tre may be observed in conditions tke cute lomeruloneptvs. For sample showing very high tre of ASO in the Inia phase successive testing after 10 to 12 days should be carted ot. TO REMEMBER: 1. Bring all the reagents and samples to room temperature before 2.Do not use haemolysed or tubid serum as it may load to non spect resus ‘3. While dispensing latex reagent, hod lass cropper vertical to get uniform drop size 4.Do not freeze the latex reagent 5. Do notread result beyond 2 mins time. 6. Poaitve samples shouldbe further tested for quatatve ASO tie, 7.Do not perform test directly under fon '8. Care should be taken to empty dropper after every us. 8. Donotuse plasma a it may ea to false Positive resus REFERENCES 1 RantzLD, Dicaprio JM, Randall E, Am. J. Mod. Sei, 24, 1952 2. Kian GC 1976, Manual of Cinical Immunology ASM, 264 3. Medical Bactorology N.C. Day 6" eitonP. 188. 204. Code No. Pack Size 180 2T CE J80B 50T fee Joc 100 424, NEW GIDC, KABILPORE, NAVSARI - 396 424. INDIA CRP (LATEX METHOD) INTENDED USE : ‘This diagnostic reagent kit is intended for invro determination ‘of C- Reactive protein in serum by qualitative and semi quantitative latex slide method PRINCIPLE : ‘The CRP-atexis aside agglutination test forthe qualtative and

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