Safe Home Testing Kits 99% Accuracy , Oral Fluid Hiv Rapid Test Kit Plastic Housing
Safe Home Testing Kits 99% Accuracy , Oral Fluid Hiv Rapid Test Kit Plastic Housing
Safe Home Testing Kits 99% Accuracy , Oral Fluid Hiv Rapid Test Kit Plastic Housing

Safe Home Testing Kits 99% Accuracy , Oral Fluid Hiv Rapid Test Kit Plastic Housing

MOQ:5000pcs
PRODUCT DESCRIPTION
High Light:

home medical test kits

,

home health test kits

Brand Name New Life
Certification ISO13485, CE
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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Safe Home Testing Kits 99% Accuracy , Oral Fluid Hiv Rapid Test Kit Plastic Housing
Safe Home Testing Kits 99% Accuracy , Oral Fluid Hiv Rapid Test Kit Plastic Housing
MOQ: 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
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.

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PRODUCT DESCRIPTION
High Light:

home medical test kits

,

home health test kits

Place of Origin China
Brand Name New Life
Certification ISO13485, CE
Minimum Order Quantity 5000pcs
Packaging Details 1pc/pouch, 25pcs/box
Delivery Time 20-30days
Payment Terms T/T, Western Union, MoneyGram
Supply Ability 2000000pcs/month
Category Home kits testing
Format kits home
Specimen Oral fluid
Testing time 5-15 minutes
Shelf Life 24 Months
Application HIV oral fluid home use
Accuracy 99.30%

 

Safe Home Testing Kits 99% Accuracy , Oral Fluid Hiv Rapid Test Kit Plastic Housing

Description:

Private use HIV Oral fluid self test kit, testing for private disease, easily and safe, 99% accuracy, personal package

 

 

INTENDED USE:

 

The HIV Oral fluid self test kit is a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This rapid HIV test provides results with 99.30% accuracy from oral fluid in as little as 20 minutes, thus providing results during the initial visit and enabling immediate counseling. Additionally, this test will be useful for pregnant women who do not know their HIV status at the time of delivery and for health care workers after accidental exposures to body fluids from infected individuals.

 

 

INTRODUCTION

 

The HIV Oral fluid self test kit utilizes a proprietary lateral flow immunoassay procedure. The device’s plastic housing holds an assay test strip comprised of several materials that provide the matrix for the immunochromatography of the specimen and the platform for indication of the test results. The assay test strip, which can be viewed through the test device result window, contains synthetic peptides representing the HIV envelope region in the Test (T) zone and a goat anti-human IgG in the Control (C) zone immobilized onto a nitrocellulose membrane.

 

 

TEST PRINCIPLE

 

 

An oral fluid specimen is collected using the flat pad on the test device, followed by insertion into the developer solution. Alternatively, a finger-stick or venipuncture whole blood specimen is collected and transferred into the vial of developer solution, followed by the insertion of the test device. The developer solution facilitates the flow of the specimen into the device and onto the test strip. As the diluted specimen flows through the device, it re-hydrates the protein-A gold colorimetric reagent contained in the device. As specimen continues to migrate up the strip, it encounters the T zone. If the specimen contains antibodies that react with the antigens immobilized on the nitrocellulose membrane, a reddish-purple line will appear, qualitatively indicating the presence of antibodies to HIV-1 and/or HIV-2 in the specimen. The intensity of the line color is not directly proportional to the amount of antibody present in the specimen. Further up the assay strip, the sample will encounter the C zone. This built-in procedural control serves to demonstrate that a specimen was added to the vial and that the fluid has migrated adequately through the test device. A reddish-purple line will appear in the C zone during the performance of all valid tests, whether or not the sample is positive or negative for antibodies to HIV-1 and/or HIV-2.

 

The test results are interpreted after 20 minutes but not more than 40 minutes after the introduction of the test device containing the test specimen into the developer solution.

 

 

TEST PROCEDURE

 

  1. Before test, please gargle gently with warm boiled water, do not drink or eat for half an hour before collect specimen.
  2. Place the flat pad above the teeth against the outer gum. Gently swab completely around the outer gums, both upper and lower, one time around, using the flat pad. Do not swab the roof of the mouth, the inside of the cheek or the tongue.
  3. Carry the flat pad to the test stand and insert the flat pad into the tube of developer solution. Be sure that the result window faces forwarded, the flat pad touches the bottom of the developer solution vial.
  4. Do not cover the two holes in the back of the test device after placing it into the developer solution. Doing so may cause an invalid result. Leave the test device in the developer solution vial and start a timer. Do not move the test stand, or remove the test device from the vial once the test dev9ice has been inserted, until you have read the results.
  5. Read the results after at least 20 minutes but not more than 40 minutes in a well-lighted area.
  6. Read the results: Note whether there is a band opposite the “ C” AND “ T” area.

 

QUALITY CONTROL

 

Built-in Control Features

 

HIV Oral fluid self test kit has a built-in procedural control that demonstrates assay validity. A reddishpurple line in the Control (“C”) area of the Result Window indicates that a specimen was added and that the fluid migrated appropriately through the Test Device. The Control line will appear on all valid tests, whether or not the sample is reactive or nonreactive. (Refer to Test Result and Interpretation of Test Result section below.)

 

External Quality Control

 

 

HIV Oral fluid self test kit Controls are available separately for use only with the HIV Oral fluid self test kit. The Kit Controls are specifically formulated and manufactured to ensure performance of the Test, and are used to verify your ability to properly perform the test and interpret the results. The HIV-1 and HIV-2 Positive Controls will produce a reactive test result and have been manufactured to produce a very faint Test (“T”) line. The Negative Control will produce a nonreactive test result. (Refer to Test Result and Interpretation of Test Result section below.) Use of kit control reagents manufactured by any other source may not produce the required results, and therefore, will not meet the requirements for an adequate quality assurance program for the HIV Oral fluid self test kit.

 

PERFORMANCE STUDY

 

Detection of Antibody to HIV-1 in Oral Fluid Specimens from HIV-1 Seropositive Individuals

 

 

         
  Total   Repeatedly True Positive1
Test Group Samples Reactive Reactive
Known HIV-1        
Positive 767 762 764 767
High-Risk 3150 722 743 73
TOTAL 3917 834 838 840

 

 

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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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