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Swab Specimen Infectious Disease Blood Tests , Self Blood Test Kit For M. Pneumoniae Antigens

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Swab Specimen Infectious Disease Blood Tests , Self Blood Test Kit For M. Pneumoniae Antigens

China Swab Specimen Infectious Disease Blood Tests , Self Blood Test Kit For M. Pneumoniae Antigens supplier

Large Image :  Swab Specimen Infectious Disease Blood Tests , Self Blood Test Kit For M. Pneumoniae Antigens

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: Disease Format: Strip/cassette
Specimen: Swab Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: Mycoplasma Pneumoniae Antigen
Accuracy: 98.15%

4mm cassette Mycoplasma pneumoniae Antigen Rapid Diagnostic test , quickly and easily, gold colloidal method

 

 

 

Accessories:

 

Test Cassettes Sterilized Swabs Sample Extraction Buffer
Tube Tips Workstation Package Insert
Extraction Tubes    

 

 

Intended Use:

 

 

Mycoplasma pneumoniae Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Mycoplasma pneumoniae(M. pneumoniae) antigens in human throat swabs. It is intended to aid in the rapid differential diagnosis of Mycoplasma pneumoniae infections.

 

TEST PRINCIPLE

 

The Mycoplasma pneumoniae Antigen Rapid Test Cassette a qualitative, lateral flow immunoassay for the detection of M. pneumoniae antigen in a throat swab. In this test, antibody specific to M. pneumoniae antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to M. pneumoniae that is coated onto particles. The mixture migrates up the membrane to react with the antibody to M. pneumoniae on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

 

TEST PROCEDURE

 

Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.

 

Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

  1.  Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of solution (Approx. 400μl) to the Extraction Tube. See illustration 1.
  2.  Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. See illustration 2.
  3.  Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. See illustration 3.
  4.  Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4
  5.  Add three drops of the solution (approx.120μl) to the sample well and then start the timer. Read the result 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.

 

Swab Specimen Infectious Disease Blood Tests , Self Blood Test Kit For M. Pneumoniae Antigens

 

 

PERFORMANCE CHARACTERS:

 

Sensitivity, Specificity and Accuracy

 

The Mycoplasma pneumoniae Antigen Rapid Test Cassette (Throat Swab) has been evaluated with specimens obtained from the patients. PCR is used as the reference method for the Mycoplasma pneumoniae Antigen Rapid Test Cassette (Throat Swab). Specimens were considered positive if PCR indicated a positive result. Specimens were considered negative if PCR indicated a negative result.

 

 

Method PCR Total Result
Mycoplasma pneumoniae Antigen Rapid Test Cassette(Throat Swab) Results Positive Negative
Positive 33 3 36
Negative 2 233 235
Total Result 35 236 271

 

Relative sensitivity: 94.3% (95%CI*: 80.8%~99.3%);

 

Relative specificity: 98.7% (95%CI*: 99.6%~100.0%);

 

Accuracy: 98.2% (95%CI*: 95.7%~99.4%). *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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