Monkeypox Virus Antigen Rapid Test Monkeypox Symptoms

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HMKP054G
• 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
The Monkeypox Virus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Monkeypox antigen in human skin lesion swab, or mucous membrane swab specimen in individuals who are suspected of monkeypox-like symptoms or recent contact with monkeypox infected patients.
 

SUMMAR
MATERIALS

Materials Provided

1. Foil pouches, each contains one test cassette, and one disposable dropper with desiccant bags
2. Assay buffer tubes (0.8ml each)
3. Disposable sampling swabs
4. Paper tube holder
5. Instruction for use

Materials Required But Not Provided

1. Timer

TEST PROCEDURE

Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Suck the treated sample extraction from the assay buffer tube and place 3 drops into the specimen well (S) of the test cassette. Start the timer.  
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

 

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

PERFORMANCE CHARACTERIST

1. Sensitivity, Specificity and Accuracy
The relative sensitivity and specificity of the Monkeypox Virus Antigen Rapid Test has been studied with the simulative positive cases and clincal negative cases. Below are the data we observed.

Method		Gold standard reagent (PCR)		Total Results
Monkeypox Virus Antigen Rapid Test	Results	Positive	Negative
	Positive	10	0	10
	Negative	0	201	211
Total Result		10	201	211

Relative Sensitivity: 100.00% (95%CI: 67.91%~100.00%)  
Relative Specificity: 100.00% (95%CI:97.74%~100.00%) 
Accuracy: 100.00% (95%CI:97.85%~100.00%)
2.Detection Of Limit
The detection limit of monkeypox A29L protein was studied by the Monkeypox Virus Antigen Rapid Test. According to the test results, the lowest detection limit of the rapid test is 0.1ng/ml to A29L protein.

3.Hook Effect

The Monkeypox Virus Antigen Rapid Test was used to study the hooking effect of strongly positive samples at different dilution concentrations. Results: Hook effect occurred when the positive sample (spiked recombinant A29L protein) was 5μg/ml.
4.Cross-reactivity
No cross reaction was observed when samples enriched with the following relative pathogens: Herpes Simplex virus type 2, Varicella zoster virus, Enterovirus 71, Influenza A, Influenza B, Human coronavirus (229E, HKU1, OC43 and NL63), Parainfluenza virus (type 1-4), Sars-CoV2 virus (alpha, beta, delta,  variants), Mycoplasma pneumoniae, adenovirus, respiratory syncytial virus, Neisseria meningitidis, mumps virus, Staphylococcus aureus, Streptococcus pneumoniae.
5.Interfering Substances: 
No interference was observed to the test strip, with the following compounds: Alpha-interferon, purified Mucin, whole blood, budesonide nasal spray,  Oxymetazoline, HAMA, Fluticason propionate. 
6.Precision (Repeatability & Reproducibility)
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens: a negative, a weak positive and a positive standard. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same two specimens: a negative, a weak positive and a positive standard. Three different lots of the Monkeypox Virus Antigen Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.