Orient New Life Medical Co.,Ltd.

 

Quality is life.

 

Home
Products
About Us
Factory Tour
Quality Control
Contact Us
Request A Quote
Company News
Home ProductsInfectious Disease Blood Tests

Gold Colloidal Infection Blood Test Detect Leptospria Antibody Cleared CE Mark

Certification
Good quality Home Testing Kits for sales
Good quality Home Testing Kits for sales
We are satisfied with your quality & services so far. The HIV 1/2 antibody Test performance is perfect.

—— Katrina

I have to say that New Life provides high quality products. The FOB, Troponin I, HIV, HCV, Drug Abuse test all performed very well in our market.

—— Clemen

Your Dengue IgG/IgM and Malaria test perfromed well. Now we want to try your Filariasis test in our market.

—— Primo

I'm Online Chat Now

Gold Colloidal Infection Blood Test Detect Leptospria Antibody Cleared CE Mark

China Gold Colloidal Infection Blood Test Detect Leptospria Antibody Cleared CE Mark supplier
Gold Colloidal Infection Blood Test Detect Leptospria Antibody Cleared CE Mark supplier Gold Colloidal Infection Blood Test Detect Leptospria Antibody Cleared CE Mark supplier

Large Image :  Gold Colloidal Infection Blood Test Detect Leptospria Antibody Cleared CE Mark

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,CE
Model Number: Cassette

Payment & Shipping Terms:

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
Contact Now
Detailed Product Description
Category: Infectious Format: Strip/cassette
Specimen: Whole Blood/Serum/Plasma Testing Time: 5-15 Minutes
Shelf Life: 24 Months Appilcation: Leptospira IgG/IgM
Senstivity: 98.17%

One Step Leptospira IgG/IgM Rapid Diagnostic test ,detection of Leptospria Antibody, gold colloidal method

 

 

 

Intended Use:

 

The Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Leptospira interrogans in human’s whole blood, serum or plasma.

 

Summary:

 

Leptospirosis occurs worldwide and is a common mild to severe health problem for humans and animals, particularly in area with a hot and humid climate. The natural reservoirs for leptospirosis are rodents as well as a large variety of domesticated mammals. Human infection is caused by Leptospira interrogans, the pathogenic member of the genus of Leprospira1,2. The infection is spread via urine from the host animal.

After infection, leptospires are present in the blood until they are cleared after 4 to 7 days following the production of anti-Leptospira interrogans antibodies, initially of the IgM class. Culture of the blood, urine and cerebrospinal fluid is an effective means of confirming the diagnosis during 1st to 2nd weeks after exposure. Serological detection of anti- Leptospira interrogans antibodies is also a common diagnostic method. Tests are available under this category:1) The microscopic agglutination test (MAT) ; 2) ELISA; 3) Indirect fluorescent antibody tests (IFATs)6. However, all above mentioned methods require a sophisticated facility and well- trained technicians.

 

 

TEST PRINCIPLE

 

The Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of IgG and IgM antibodies to Leptospira in whole blood, serum or plasma. The membrane is pre-coated with recombinant HCV antigen on the test line region of the cassette. During testing, the whole blood, serum or plasma specimen reacts with recombinant Leptospira interrogans antigen conjugated colloid gold. The mixture migrates upward on the membrane chromatographically by capillary action to react with mouse anti-human IgG or/and mouse anti-human IgM on the membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

 

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 cassette from the sealed pouch and use it within one hour. Best results will be obtained if the assay is performed as soon as possible.

3. Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the specimen about 1cm above the upper end of the nozzle as shown in illustration below. Transfer 1 full drop (approx. 20μL) of specimen to each sample well, then add 2 drops of buffer (approximately 80μL) to each sample well and start the timer. See the illustration below.

4. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 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.

 

Gold Colloidal Infection Blood Test Detect Leptospria Antibody Cleared CE Mark

 

 

PERFORMANCE CHARACTERS:

 

Sensitivity and Specificity

 

A total of 230 samples from susceptible subjects were tested by the Leptospira IgG/IgM Rapid Test Cassette and by a commercial Leptospira IgM EIA kit. Comparison for all subjects is shown in the following table.

 

IgM Results

 

Method ELISA Total Results
Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Results Positive Negative
Positive 9 3 12
Negative 1 217 218
Total Results 10 220 230

 

Relative Sensitivity: 90.0% (95%CI*: 55.5%-99.7%)

 

Relative Specificity: 98.6% (95%CI*: 96.1%-99.7%)

 

Accuracy: 97.4% (95%CI*: 94.7%-98.9%) *Confidence Intervals

 

A total of 239 samples from susceptible subjects were tested by the Leptospira IgG/IgM Rapid Test Cassette and by a commercial Leptospira IgG EIA kit. Comparison for all subjects is shown in the following table.

 

IgG Results

 

Method ELISA Total Results
Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Results Positive Negative
Positive 15 3 18
Negative 1 220 221
Total Results 16 223 239

 

Relative Sensitivity: 93.8% (95%CI*: 69.8%-99.8%)

 

Relative Specificity: 98.7% (95%CI*: 96.1%-99.7%)

 

Accuracy: 98.3% (95%CI*: 95.8%-99.5%)

 

 

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.

 

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

Contact Details
Orient New Life Medical Co.,Ltd.

Contact Person: Jerry Meng

Send your inquiry directly to us (0 / 3000)