trichomonas rapid test kit

1. SPECIFICATION SHEET Rev 120201HML Trichomonas Vaginalis (T.V) Rapid Test Kit Prod. No.: DTS054 Pkg.Size: 20T INTENDED USE FEATURE The Trichomonas V. ( T.V )rapid test is a qualitative assay which detects T. vaginalis antigen by color immunochroma- tographic technology . The test procedure requires the extrac- tion of T.V secreted protein from vaginal swab taken from pa- tient. The TV strip is then placed in extraction mixture and mix- ture migrated along the membrane surface. Easy to use: One reagent, dipstick simply. Accurate: 95%agreement against composite wet and cul- ture Fast: Result in 5-15minutes Flexible: User convinces and friendly Obiective: Provide easy to visual read two color results. GENERAL DESCRIPTION COMPARISION OF T.V DETECTION METHOD Detection Method Wet Mount Staining T.V Test Kit Culture PCR Sensitivity (%) 52% 24% 90-95% 78% 84% Specificity (%) ＞90% 99% 99% ＞95% 94% Trichomonas Vaginalis is the most common nonviral sexually transmitted infection ( STI ) globally and in the United States. Although there is no reportable STI in the United States, an estimated five million women and one million men are infected annually with Trichomonas vaginalis, a common cause of vagin- itis and urethritis. The prevalence in women has ranged from 2% in lowrisk populations to 60% in the highest-risk groups. As many as 80% of women with trichomoniasis have been asymp- tomatic in some settings and in the absence of treatment, infec- tion is thought to persist for years. T. vaginalis infection has been associated with adverse pregnancy outcomes and with increased human immunodeficiency virus (HIV) shedding in women infected with both T. vaginalis and HIV. Although culture is the ‘‘ gold standard ‘‘ for the diagnosis of trichomoniasis, it is not widely available. PCR method has been shown to have high sensitivity but also is not widely available. Microscopic examina- tion of vaginal secretions (wet preparation) is most frequently used diagnostic test for trichomoniasis. However, test sensitivity depends greatly on examiner expertise and access to a micro- scope is required. The performance of the Trichomonas V. antigen Test was determined using a composite reference standard (CRS), comparing the test to wet mount microscopy and in pouch culture. Method ( N=204) Microscopy Culture T. V. Ag test kit Sensitivity 72.8% 91.3% 99% Specificity 78.6% 92% 100% The Trichomonas V. antigen Test identified ALL samples positive by either wet mount or microscopy and resolving all samples against culture The results are summarized as be- low: The Trichomonas V. antigen Test will detect soluble antigen present in vaginal samples from > 20 organisms, a number of organisms that is lower than that expected from discharge of patients. PRINCIPLE OF THE TEST 1) a burgundy-colored conjugate pad containing colloidal gold coupled with Trichonomas V. polyclonal antibodies, 2) nitrocellulose membrane containing a test line ( T - line) and a control line (C- line). The T line is coated with Trichomonas V. antibody, and the C- line is coated with goat anti-Trichmonas.V iantibody. When patient antigen to Trichomonas V. are present in the specimen, the T line will become a burgundy-colored band. If antigen to Trichomonas V. are not present or are present below the detectable level, no T line will develop. The C line should always appear as a burgundy-colored band regardless of the presence of antigen to Trichomonas V. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. TEST PROCEDURE 1. Add 1ml buffer into the vagina secretion sample, shake and mix well 2. Put the strip vertically 3. Take the strip out and lay it flat on a clean, dry and non- absorbent surface 4. 5-15minutes interpretation Creative Diagnostics. All rights reserved. 45-16 Ramsey Road Shirley, NY 11967, USA Tel: 631-624-4882 ·Fax:631-614-7828 E-mail: info@creative-diagnostics.com www.creative-diagnostics.com

2. SPECIFICATION SHEET Rev 120201HML INTERPRETATION OF RESULTS A total absence of color in both (C) and (T) regions or no colored band appears on the control (C) region is an indication of pro- cedure error and/or the test reagent has deteriorated. Repeat with a new test kit. If the problem persists, discontinue using the test kit immediately and contact your local distributor. NOTES The test result must be combined with clinic diagnosis and procedure. Creative Diagnostics. All rights reserved. 45-16 Ramsey Road Shirley, NY 11967, USA Tel: 631-624-4882 ·Fax:631-614-7828 E-mail: info@creative-diagnostics.com www.creative-diagnostics.com