Mycoplasma Pneumoniae Antigen Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HMP023G
• Blood Sampling Needle: None
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

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

DIRECTIONS FOR USE

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.

INTERPRETATION OF RESULTS
POSITIVE: Two colored lines appear. One colored line appears in the control region(C), and one colored line in the test region(T). The shade of color may vary, but it should be considered positive wheneverthere is even a faint line.
NEGATIVE: Only one colored line appears in the control region(C), and no line in the test region(T). The negative result indicates that there are no M. pneumoniae in the sample or the number of M. pneumoniae is below the detectable range.
INVALID: No line appears in the control region(C). The test is invalid even if there is a line on test region(T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

PERFORMANCE CHARACTERISTSensitivity, 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.
Cross-reactivity

1. Virus

No cross reaction with following pathogens:
Influenza virus A(H1N1,H3N2), Influenza virus B;Adenovirus Type 1 ~ 8,11,19,37, Coxsackie virus Type A16,B1~5, Cytomegalovirus, Echovirus Type 3,6,9,11,14,18,30, Enterovirus Type 71, HSV-1, Mumps virus, Parainfluenza virus Type 1~3, Poliovirus Type 1~3, Respiratory syncytial virus, Rhinovirus Type 1A,13,14.

1. Mycoplasma etc.

No cross reaction with Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis.

1. Bacteria

No cross reaction with following bacteria:
Acinetobacter baumannii.Bacteroides fragilis, Bordetella pertussis, Candida albicans, Candida glabrata, Cardiobacterium hominis .EikeneUa corrodens, Enterococcus gallinarum. Escherichia coil , Haemophilus phrophlus, aemophilus influenzae, Haemophilus parainfluenzae, Haemophilus paraphrophilus, Kingella kingae, Klebsiella pneumoniae, Listeria monocytogenes, Moraxella catarrhalis, Neisseria gonorrhoeae Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus, pyogenes, Streptococcus agalactiae, Streptococcus sp. group C, G, F, Streptococcus mutans