The Trichomonas Vaginalis Antigen Rapid Test is intended for the qualitative detection of Trichomonas vaginalis(“Trichomonas”) antigens from vaginal swabs or from the saline solution prepared when making wet mount  from vaginal swabs. This kit is intended to be used as an aid in the diagnosis of Trichomonas infection. 

INTRODUCTION
Trichomonas infection is responsible for the most common, non-viral sexually transmitted disease (vaginitis or trichomoniasis) worldwide. Trichomoniasis is a significant cause of morbidity among all infected patients.(1,2) Effective diagnosis and treatment of Trichomonas infections have been shown to eliminate symptoms.(2)  Conventional identification procedures for Trichomonas from vaginal swabs or vaginal washes involve the isolation and subsequent identification of viable pathogens by wet mount microscopy or by culture,(3) a process that will cost  24 -120 hours. Wet mount microscopy has a reported sensitivity of 58% versus culture.(4) The Trichomonas Rapid Test is an immunochromatographic assay that detects pathogen antigens directly from vaginal swabs. Results are rapid, occurring within approximately 10 minutes. 

PRINCIPLE
The Trichomonas Vaginalis Antigen Rapid Test uses color immunochromatographic, capillary flow technology. The test procedure requires the solubilization of Trichomonas proteins from a vaginal swab by mixing the swab in Sample Buffer. Then the mixed sample buffer is added to the test cassette sample well and the mixture migrates along the membrane surface. If Trichomonas is present in the sample, it will form a complex with the primary anti-Trichomonas antibody conjugated to colored particles (red). The complex will then be bound by a second anti-Trichomonas antibody coated on the nitrocellulose membrane. The appearance of a visible test line along with the control line will indicate a positive result. 

KIT COMPONENTS

20 Individually packed test devices	Each device contains a strip with colored conjugates and reactive reagents pre-coated at the corresponding regions.
2 Extraction Buffer vial	0.1  M  Phosphate  buffered  saline  (PBS)  and 0.02% sodium azide.
1 Positive control swab (on request only)	Contain inactived trichomonas and sodium azide. For External control.
1 Negative control swab (on request only)	Not contain trichomonas. For external control.
20 Extraction tubes	For specimens preparation use.
1 Workstation	Place for holding buffer vials and tubes.
1 Package insert	For operation instruction.

PRECAUTIONS

• For professional in vitro diagnostic use only.
• Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to performing any tests.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Do not interchange or mix reagents from different lots. Do not mix solution bottle caps.
• Humidity and temperature can adversely affect results.
• When the assay procedure is completed, dispose the swabs carefully after autoclaving them at 121°C for at least 20 minutes. Alternatively, they can be treated with 0.5% sodium hypochloride (or house-hold bleach) for one hour before disposal. The used testing materials should be discarded in accordance with local, state and/or federal regulations.
• Do not use cytology brushes with pregnant patients.

STORAGE

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results. 

SPECIMEN COLLECTION AND STORAGE
Use only Dacron or Rayon tipped sterile swabs with plastic shafts. It is recommend to use the swab supplied by the kits manufacturer(The swabs are not contained in this kit, for the ordering information, please contact the manufacture or local distributor, the cataloge number is 207000). Swabs from other suppliers have not been validated. Swabs with cotton tips or wooden shafts are not recommended.

• Insert the swab into the inside of the vagina, and rotate for 20sec. Pull the swab out carefully!
• Do not place the swab in any transport device containing medium since transport medium interferes with the assay and viability of the organisms is not required for the assay. Put the swab to the extraction tube, if the test may be run immediately. If immediate testing is not possible, the patient samples should be placed in a dry transport tube for storage or transport. The swabs may be stored for 24 hours at room temperature (15-30°C) or 1 week at 4°C or no more than 6 month at -20°C. All specimens should be allowed to reach a room temperature of 15-30°C before testing.
• Do not use 0.9% sodium chloride to treat swabs before collecting specimens.
• The solution remaining in the test tube used for the wet mount may also be used as the sample for the trichomonas test. To use this sample type, add 3 drops of the solution to the sample well directly. These saline specimens may be held at room temperature for no longer than 24 hours. These specimens may also be stored at 4°C for up to 1 week or -20°C for 6 month.
• To run a culture as well as the Test, Separate swabs must be collected because the sample buffer will kill Trichomonas organisms.

Our mission:

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.

 
Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Rebecca Yan

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
Rapid Tests for Human Use :
1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
2) Infectious diseases: Hepatitis B, HCV, HIV
3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
4) Tumor markers: CEA, PSA, AFP, FOB
5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
Rapid Tests for Veterinary :
1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
Rapid Tests for Food Safety :
1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol