High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method
High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method
High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method

High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method

MOQ:5000pcs
Price:USD0.1-USD1
PRODUCT DESCRIPTION
High Light:

bacterial infection blood test

,

home blood test kit

Brand Name New Life
Certification ISO13485,
Delivery Time 20-30days
Minimum Order Quantity 5000pcs
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ABOUT US
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
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High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method
High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method
MOQ: 5000pcs
Price:USD0.1-USD1
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About Us
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
Company Name Orient New Life Medical Co.,Ltd.
Business Type: Manufacturer,Exporter
Brands: New Life
No. of Employees: 200~300
Year Established: 2009
Annual Sales: 10,000,000-15,000,000
Company Location 12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China
Factory Location No.1369, Chengnan Road, Jiaxing, Zhejiang, China
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

 

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

 

Company's core technical team with more than 35 employees,3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.

Get Latest Price For Your Requirement
PRODUCT DESCRIPTION
High Light:

bacterial infection blood test

,

home blood test kit

Place of Origin China
Brand Name New Life
Certification ISO13485,
Minimum Order Quantity 5000pcs
Price USD0.1-USD1
Packaging Details 1pc/pouch, 25pcs/box
Delivery Time 20-30days
Payment Terms T/T, Western Union, MoneyGram
Supply Ability 10000000pcs/month
Category Infectious
Format Strip/cassette
Specimen Whole Blood/Serum/Plasma
Testing time 5-15 minutes
Shelf Life 24 Months
Application Syphilis test
Accuracy 99.915%

 

High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method

Description:

High Accuracy One Step Syphilis Rapid Diagnostic test Whole Blood/SerumPlasma specimen Gold Colloidal Method

 

Product Name:


Syphilis Rapid Diagnostic test

 

 

Intended Use:

 

The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.

 

Summary:

 

Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.1 Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly increased since 1985.2 Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users.3 One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis.4

Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment.5

The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in whole blood, serum or plasma.

 

 

 

TEST PROCEDURE

 

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

 

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

 

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

 

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

 

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

 

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

 

 

 

INTERPRETATION OF RESULTS

 

Positive:

Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

 

Negative:

The control line appears in the result window, but the test line is not visible.

 

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

 

 

 

 

PERFORMANCE CHARACTERS:

 

 

Clinical Sensitivity, Specificity and Accuracy

 

The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPHA Syphilis test using clinical specimens. The results show that the relative sensitivity of The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is 99.5% and the relative specificity is 99.3%.

 

Syphilis Rapid Test Device vs. TPHA

 

Method TPHA Total Results
Syphilis Rapid Test Device Results Positive Negative
Positive 394 4 398
Negative 2 540 542
Total Results 396 544 940

 

Relative sensitivity: 99.5% (98.2%-99.9%)* Relative specificity: 99.3% (98.1%-99.8%)*

 

Accuracy: 99.4% (98.6%-99.8%)* * 95% Confidence Intervals

 

 

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

 

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ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry
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