Basic Info.
Model NO.
DGNTP-02
Group
Adult
Material
Plastic and Paper
Logo Printing
OEM
Shelf Time
24 Months
Specimen
Blood
Application
Luteinizing Hormone Surge Stage
Product Type
Strip, Cassette
Size Regular
2.5mm, 3.0mm
Package
Foil Bag and Box and Carton
Payment
Tt, Paypal, Western Union
Sample
Available to Prepare
Certificate
CE, ISO FSC
Packing Size
63*26*49cm
Gross Weight
13kg
Transport Package
Carton
Specification
Standard
Trademark
Diagnos
Origin
Jiangsu China
HS Code
3822001000
Production Capacity
5000000 PCS/Month
Product Description
High quality; Mutual-benefit price; Fast delivery; Best service
Product Description
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********* TP/Syphilis test kit *********
| Format | strip; cassette |
| Specimen | Whole blood/serum/plasma |
| Accuracy | Over 99% |
| Read time | 10mins |
| Expiry date | 24-36months |
| Certificate | CE, FSC,ISO13485 |
Specification
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********* TP/Syphilis test kit *********
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Product Principle of TP/Syphilis test kit
One Step Anti-Syphilis Test is a rapid direct binding test for the visual detection of anti-syphilis
antibodies in serum as an aid in the diagnosis of syphilis infection.
Test results are read visually without any instrument.
It is based on the principle of double antigen sandwich immunoassay for determination of syphilis
antibodies in serum.
Purified recombinant syphilis antigens are employed to identify anti-Syphilis antibodies specifically.
This one step TP/syphilis test kit is very sensitive and only takes about 10 to 15 minutes.
| Product type | Strip, cassette |
| Usual size | Strip: 2.5-4.0mm; Cassette: 3.0 or 4.0mm |
| Specimen | Whole blood, serum/plasma |
| Application period | Primary infection period or with symptoms |
| Type 1. TP/Syphilis test strip Size: | 2.5mm, 3.0mm, 3.5mm, 4.0mm |
| Type 2. TP/Syphilis test cassette Size: | 5.0mm 6.0mm |
| Storage | Indoor temperature of 2-30 degrees |
| Advantage | easy to use, fast to read result, accuracy and stable application, private usage |
Product Paramenters
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Example of statistical results of reagent of 240 samples
| Reagent | Control reagent kit Positive Negative | Total | Specificity: Sp=100% False positive rate =0% False negative rate =0% Total accordance rate = 100% | |
| Positive | 100 | 0 | 100 | |
| Negative | 0 | 140 | 140 | |
| Total | 100 | 140 | 240 | |
TP/Syphilis test kit strip using procedure
> 1. Allow the sealed TP/Syphilis test pouch, blood sample, and control solution to reach room temperature (18-30C).
>2. Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the
MAX (maximum) line.
> 3. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface
(e.g., mouth of the serum container).
> 4. Wait 10-15 minutes and read result. Do not read results after 30 15 minutes
>2. Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the
MAX (maximum) line.
> 3. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface
(e.g., mouth of the serum container).
> 4. Wait 10-15 minutes and read result. Do not read results after 30 15 minutes
 |
TP/Syphilis test kit cassette using procedure
>1. Allow the sealed TP/Syphilis test pouch, blood sample, and control solution to reach room temperature (18-30C).
Get the cassette out of the foil bag and lay flat
>2. Drip 2 or 3 drops of blood specimen into the sample well.
>3. Wait 10-15 minutes and read result. Do not read results after 30 15 minutes
INTERPRETATION OF RESULTS
1. Negative: Only one pink band appears on test region. This indicates that there is no detectable Syphilis in the specimen.
2. Positive: Two pink bands appear on test region. This indicates that the specimen contains detectable amount of syphilis.
3. Invalid: If without colored band appears on test region, this is an indication of a possible error in performing operation.
Need to repeat the process with a new device.
PRECAUTION OF TP/SYPHILIS TEST OPERATION
>1. Allow the sealed TP/Syphilis test pouch, blood sample, and control solution to reach room temperature (18-30C).
Get the cassette out of the foil bag and lay flat
>2. Drip 2 or 3 drops of blood specimen into the sample well.
>3. Wait 10-15 minutes and read result. Do not read results after 30 15 minutes
 |
INTERPRETATION OF RESULTS
1. Negative: Only one pink band appears on test region. This indicates that there is no detectable Syphilis in the specimen.
2. Positive: Two pink bands appear on test region. This indicates that the specimen contains detectable amount of syphilis.
3. Invalid: If without colored band appears on test region, this is an indication of a possible error in performing operation.
Need to repeat the process with a new device.
PRECAUTION OF TP/SYPHILIS TEST OPERATION
- Must use fresh specimen and avoid repetitive freezing, the result will be invalid
- Use it before expiry date.
- The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
- Old Serum can not be used. If the serum is thick, it can be used only after being separated.
Packing & Delivery
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Package: go as normal package or as per clients needs.
Out carton size:63*26*49CM; Gross weight: 13KG
Out carton size:63*26*49CM; Gross weight: 13KG
Shipping: by sea or by air.
Company Profile
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*Nantong Diagnos Biotechnology Co., Ltd. (Diagnos) is a professional POCT (point-of-care testing)
manufacturer in China, found in 2006, specialized in researching, developing, manufacturing and
distributing advanced medical instruments and in-vitro medical diagnostic products.
*Diagnos offers quality products in the following specialties: Fertility, Infectious Diseases, Tumor Markers,
Cardiac Markers, Substance of Drug Abuse tests and etc.
*With the strong support from the government, Diagnos has obtained ISO9001 certificate, ISO13485
certificate and CE Mark already.
*Diagnos focuses on excellent client-centered support with experienced sales and marketing team that is
fluent in both Chinese and English, in addition to strong international import - export experience.
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
*Nantong Diagnos Biotechnology Co., Ltd. (Diagnos) is a professional POCT (point-of-care testing)
manufacturer in China, found in 2006, specialized in researching, developing, manufacturing and
distributing advanced medical instruments and in-vitro medical diagnostic products.
*Diagnos offers quality products in the following specialties: Fertility, Infectious Diseases, Tumor Markers,
Cardiac Markers, Substance of Drug Abuse tests and etc.
*With the strong support from the government, Diagnos has obtained ISO9001 certificate, ISO13485
certificate and CE Mark already.
*Diagnos focuses on excellent client-centered support with experienced sales and marketing team that is
fluent in both Chinese and English, in addition to strong international import - export experience.
Our Advantages
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FAQ
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1. Q: Sample available?A: Reasonable quantity free samples will be available to sent for quality evaluation.
2. Q: Do you have minimum order quantity requirements?A: Yes, but quantity can be negotiated.
3. Q: Can we visit your factory?A: sure, welcome you to visit our factory any time.
4. Q: How to ensure the cargo quality?A: A professional QC team will control the goods quality during all the mass production or a third party inspection service
could be arranged at your expense if you want. We will supply bulk sample for evaluation before shipping.
6. Q: Which certificates do you have?A: We already got CE 0123, ISO13485 and ISO 9001 certificate.
7. Q: How to pay?A: Payment can be made by paypal, western union, bank transfer, etc.
2. Q: Do you have minimum order quantity requirements?A: Yes, but quantity can be negotiated.
3. Q: Can we visit your factory?A: sure, welcome you to visit our factory any time.
4. Q: How to ensure the cargo quality?A: A professional QC team will control the goods quality during all the mass production or a third party inspection service
could be arranged at your expense if you want. We will supply bulk sample for evaluation before shipping.
6. Q: Which certificates do you have?A: We already got CE 0123, ISO13485 and ISO 9001 certificate.
7. Q: How to pay?A: Payment can be made by paypal, western union, bank transfer, etc.