Diagnostic Test Colloidal Gold Mycoplasma Pneumoniae Antigen Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: /
• Model NO.: HMP023G
• Blood Sampling Needle: /
• Breathing Pattern: /
• Assay Time: 15-20 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Specimen: Human Throat Swabs
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

Introduction

INTENDED USE
Mycoplasma pneumoniae Antigen Rapid Test 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.
 

SUMMAR
MATERIALS

Materials provided

• Test cassettes • Disposable Sampling Swab
• Assay buffer tubes • Workstation
• Package Insert

Materials required but not provided

• Timer

Test Procedure

TEST PROCEDURE

Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing.

1. 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.
2. 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. 500pl) to the Extraction Tube. See illustration 1.
3. 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.
4. 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.
5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4.
6. Add three drops of the solution (approx.120pl) to the sample well and then start the timer. Read the result at 15 minutes. Do not interpret the result after 20 minutes.
7.  

INTERPRETATION OF RESULTS


 

PERFORMANCE

PERFORMANCE CHARACTERIST
Sensitivity, Specificity and Accuracy
The Mycoplasma pneumoniae Antigen Rapid Test (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 (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 (Throat Swab)	Results	Positive	Negative
	Positive	172	0	172
	Negative	11	384	395
Total Result		183	384	567

Relative Sensitivity: 93.99% (95%CI: 89.45%~96.72%)  
Relative Specificity: >99.99% (95%CI:98.81%~100.00%) 
Accuracy: 98.06% (95%CI:96.52%~98.96%)

Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates off our specimens: a negative, a low positive, a middle positive and a high positive. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, a low positive, a middle positive and a high positive. Three different lots of the Mycoplasma pneumoniae Antigen Rapid Test (Throat Swab)have been tested using these specimens. The specimens were correctly identified >99% of the time.


 

Company Profile

COMPANY PROFILE


Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the  human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.
 

 

Packaging & Shipping