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One Step Infectious Disease Blood Tests , Legionella Testing Kit Cassette Format

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One Step Infectious Disease Blood Tests , Legionella Testing Kit Cassette Format

China One Step Infectious Disease Blood Tests , Legionella Testing Kit Cassette Format supplier
One Step Infectious Disease Blood Tests , Legionella Testing Kit Cassette Format supplier One Step Infectious Disease Blood Tests , Legionella Testing Kit Cassette Format supplier

Large Image :  One Step Infectious Disease Blood Tests , Legionella Testing Kit Cassette Format

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
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Detailed Product Description
Category: Infectious Format: Strip/cassette
Specimen: Urine Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: Legionella Pneumophila
Accuracy: 88.40%

One Step Legionella pneumophila Rapid Diagnostic Test,Gold colloidal method, quickly and easily

 

 

Intended Use:

 

 

A rapid test for the qualitative detection of Legionella pneumophila antigen in urine specimen.

For professional in vitro diagnostic use only.

 

 

 

TEST PRINCIPLE

 

 

The Legionella pneumophila antigen Test Dipstick is a qualitative, lateral flowimmunoassay for the detection ofLegionella pneumophila LPS in urine samples, the membrane is pre-coated with a anti-Legionella antibodies on the test line region ofthe test. During testing, the specimen reacts with the particle coated with anti-Legionella antibodies. The mixture migrates upward on the membrane by capillary action to reactwith anti-Legionella antibodies on the membrane and generate a colored line. Thepresence of this colored line in the test region indicates a positive result, while itsabsence indicates a negative result. To serve as a procedural control, a colored linewill always appear in the control line region indicating that proper volume of specimenhas been added and membrane wicking has occurred.

 

 

TEST PROCEDURE

 

Allow kit components, in unopened packaging, and specimens to reach roomtemperature (15-30°C) before performing a test.

 

1. Open the pouch and remove the device. Once opened, run the test immediately.

2.  Swirl urine gently to mix before testing.

3.  With arrows towards pointing toward urine specimen, immerse the test Dipstick vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test Dipstick when immersing the Dipstick. See illustration below.

4.  Place the Dipstick on a non-absorbent flat surface, start the timer and wait for the color line (s) to appear. The result should be read at 15 minutes, do not interpret the result 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.

 

One Step Infectious Disease Blood Tests , Legionella Testing Kit Cassette Format

 

PERFORMANCE CHARACTERS:

 

 

Sensitivity and Specificity

 

The kit was evaluated on 189 clinical samples in a National Reference Laboratory in Spain.118 positive urine specimen and 71 negative urine specimen confirmed with the ELISA. Urine samples from patients with respiratory tractinfections other than Legionella infections were tested in a similar manner to test thespecificity of the kit.

 

Method EIA Total Results
Legionellapneumophila Rapid Test Dipstick (Urine) Result Positive Negative
Positive 97 1 98
Negative 21 70 91
Total Results 118 71 189

 

Relative sensitivity: 82.2% (95%CI*: 74.1%~88.6%);

 

Relative specificity:98.6% (95%CI*: 92.4%~99.9%);

 

Accuracy: 88.4% (95%CI*: 82.9%~92.6%). *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.

 

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

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Contact Person: Jerry Meng

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