IGFBP-1 Home Fertility Testing Kits , Vaginal Secretion Pregnancy Detection Kit
IGFBP-1 Home Fertility Testing Kits , Vaginal Secretion Pregnancy Detection Kit

IGFBP-1 Home Fertility Testing Kits , Vaginal Secretion Pregnancy Detection Kit

MOQ:20000pcs
Price:USD0.10-USD0.25
PRODUCT DESCRIPTION
High Light:

female fertility test kit

,

pregnancy ovulation kit

Brand Name New Life
Certification ISO13485, CE,FDA
Delivery Time 20-30days
Minimum Order Quantity 20000pcs
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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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IGFBP-1 Home Fertility Testing Kits , Vaginal Secretion Pregnancy Detection Kit
IGFBP-1 Home Fertility Testing Kits , Vaginal Secretion Pregnancy Detection Kit
MOQ: 20000pcs
Price:USD0.10-USD0.25
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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:

female fertility test kit

,

pregnancy ovulation kit

Place of Origin China
Brand Name New Life
Certification ISO13485, CE,FDA
Model Number Cassette
Minimum Order Quantity 20000pcs
Price USD0.10-USD0.25
Packaging Details 1pc/pouch, 25pcs/box
Delivery Time 20-30days
Payment Terms T/T, Western Union, MoneyGram
Supply Ability 2000000pcs/month
Category Home Fertility kits
Format Cassette
Specimen vaginal secretion
Testing time 5-15 minutes
Shelf Life 24 Months
Application Insulin-like growth factor-binding protein 1
Sensitivity 99.12%

 

IGFBP-1 Home Fertility Testing Kits , Vaginal Secretion Pregnancy Detection Kit

Description:

iGFBP-1 Home Fertility Testing Kits, self test use at home, individual package or professional package

 

 

INTENDED USE:

 

The Insulin-like growth factor-binding protein 1 (iGFBP-1) rapid test (vaginal secretion) is a visually interpreted, qualitative immunochromatographic test device for detection of iGFBP-1 in vaginal secretions during pregnancy, which is a major protein marker of the amniotic fluid in a vaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.

 

TEST PRINCIPLE

 

The iGFBP-1 (vaginal secretion) has been designed to detect iGFBP-1 through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-iGFBP-1 antibodies on the test region. During the test, the specimen is allowed to react with colored anti-iGFBP-1 antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough iGFBP-1 in specimens, a colored band will form at the T region of the membrane. Presence of colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

 

 

TEST PROCEDURE


1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.

2. Insert the swab into the specimen tube containing 1ml of assay diluent.

3. add the Vaginal secretion into the specimen tube containing 1000ml of assay diluent using the dropper.

4. Mix the swab samples with assay diluent to extract well.

5. Hold the dropper vertically and transfer 3 full drops of specimen (approx. 100 uL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).

6. Wait for the colored band to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

 

INTERPRETATION OF RESULTS

 

POSITIVE: Two distinct colored lines are visible, and the line in the test line region (T) is the same as or darker than the line in the control line region (C). A positive result indicates that the FSH level is higher than normal and the subject may be experiencing perimenopause.

 

NEGATIVE: Two colored lines are visible, but the line in the test line region (T) is lighter than the line in the control line region (C), or there is no line in the test line region (T). A negative result indicates that the subject is probably not experiencing perimenopause in this cycle.

 

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect test performance are the most likely reasons for an invalid result. Review the procedure and repeat with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

Kit Components

 

Individually packed test Devices Each Device contains colored conjugates and reactive reagents pre-spreaded at the corresponding regions.
Specimens collection swab For specimens collection use.
Specimens dilution tube with buffer 0.1 M Phosphate buffered saline (PBS) and preservative
Package insert For operation instruction.
   

 

 

Performance

 

Sensitivity and Specificity

 

The iGFBP-1 Rapid Test Cassette (vaginal secretion) has been tested with a leading commercial iGFBP-1 Rapid Test using clinical specimens.

 

Method Other iGFBP-1 Rapid Test Total Results
iGFBP-1 Rapid Test Cassette Results Positive Negative
Positive 102 3 105
Negative 2 147 149
Total Results 104 150 254

 

Relative Sensitivity: 98.1% (95%CI:*93.2%-99.8%)

 

Relative Specificity: 98.0% (95%CI:*94.3%-99.6%)

 

Overall Accuracy: 98.0% (95%CI:*95.5%-99.4%)

 

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most

likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, please contact your local distributor.

 

 

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

 

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