Medical Equipment One Step Tp Device Syphilis Rapid Test Kit

• Type: Sexually Transmitted Disease Tests
• Group: Anyone in Need
• Certification: CE, FDA, ISO13485
• Medical Device Regulatory Type: Type 1
• Transport Package: Carton
• Specification: Strip/Cassette
• Model NO.: SYP-P23/W23
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 50000000000PCS/Year

Product Description

Medical Equipment One Step TP Device Syphilis Rapid Test Kit

Anti-Syphilis Test	SYP-P11	Serum/Plasma	Strip	50 pcs	3.0mm	CE
Anti-Syphilis Test	SYP-P23	Serum/Plasma	Cassette	20 pcs	4.0mm	CE
Anti-Syphilis Test	SYP-W11	Serum/Plasma/Whole Blood	Strip	50 pcs	3.0mm	CE
Anti-Syphilis Test	SYP-W23	Serum/Plasma/Whole Blood	Cassette	20 pcs	4.0mm	CE

Product Details
The serological diagnosis of syphilis is performed by demonstrating the presence of significant levels of specific Treponema Pallidum antibodies in serum/plasma. The commonly used reference methods and techniques require laborious execution and complicated interpretation. Alternative methods have therefore been introduced to simplify the procedure. One Step Anti-TP (Treponema Pallidum) Test is a rapid qualitative screening test that can be performed without the use of an instrument. The test utilizes purified recombinant antigen to specifically detect the presence of Treponema Pallidum specific antibodies. It allows the detection of both IgG and IgM.
 

Related information

Accuracy:>99%

Origin:China

Using:self-test

INSTRUCTION

One step Syphilis rapid rapid test kit (serum/plasma in vitro diagnostic/test foil pouch) is a sandwich method based rapid immunochromatographic assay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma to aid in the diagnosis of Syphilis.

 

MORE rapid diagnostic products supplied

HCG,LH,FSH,HIV,HBSAG,HCV,HBV,HEV,SYPLILIS,TB, HP,NGH,Chlamydia,Malaria,PSA,

CEA,FOB,Dengue,Troponin I,Toxoplasma, Drug of Abuse test, saliva alcohol test and so on 

 

TEST PROCEDURE

1. Testing Time:5 minutes
2. Specimen:Serum or plasma
3. Sampling Quantity: 50 UL,or 2 drops by the provided disposable dropper
4. Storage Temperature:2-30 C
5. Shelf Life:2 years.
6. Packing Size:40 tests/kit

TEST RESULTS

1. NEGATIVE:Only one band appears in the control region (C)
2. POSITIVE:Two bands appear individually in the control region (C) and test region (T).
3. INVALID:Control band fails to appear.

FAQ
Q1: What's the method u use to do the test?
A: Colloidal Gold Method.


Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.


Q3: What's ur packing of the tests?
A: If u choose the low cost, we will suggest you the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.


Q4: What's the main differences when comparing products from different suppliers?
A: U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.
 
Q5: Some tests can be tested with serum/plasma or with whole blood, so what's the difference?
A: Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.


Q6: How can i distinguish a good test kit?
A: U can judge from the 4facts:Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.

Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. You can refer to the instruction for more accurate time.

Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.