One Step Syphilis Home Test Kit  4mm Strip Rapid Chromatographic Immunoassay
One Step Syphilis Home Test Kit  4mm Strip Rapid Chromatographic Immunoassay
One Step Syphilis Home Test Kit  4mm Strip Rapid Chromatographic Immunoassay

One Step Syphilis Home Test Kit  4mm Strip Rapid Chromatographic Immunoassay

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

home health test kits

,

home disease test kits

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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One Step Syphilis Home Test Kit  4mm Strip Rapid Chromatographic Immunoassay
One Step Syphilis Home Test Kit  4mm Strip Rapid Chromatographic Immunoassay
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:

home health test kits

,

home disease test kits

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%

 

One Step Syphilis Home Test Kit  4mm Strip Rapid Chromatographic Immunoassay

Description:

Private Syphilis blood Home Testing kits, 99% accuracy, 4mm cassette home use test kit.

 

Product Name:


Syphilis blood Home Testing kits

 

 

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.

 

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.

 

QUALITY CONTROL

 

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

 

EXPECTED VALUE

 

The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) has been compared with a leading commercial TPHA Syphilis test, demonstrating an overall accuracy greater than or equal to 99.4%.

 

 

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

 

 

Intra-Assay

 

Within-run precision has been determined by using 10 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.

 

Inter-Assay

 

Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) have been tested over a 3-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.

 

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