Monkeypox Virus Antigen Rapid Test

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. 

PRINCIPLE

The Monkeypox Virus Antigen Rapid Test is consist with one test strips which could be observed in the window of the rapid test cassette. The strip is based on sandwich method immunochromatographic assay. The A29L protein of Monkeypox antigens are targeted in this strip.

In the test strip, anti-Monkeypox monoclonal antibodies are coated in the test lines and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-Monkeypox antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the pre-coated Monkeypox monoclonal antibodies in the test regions.

To serve as a procedural control, a colored line will always appear at the control line regions(C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND PREPARATION

The Monkeypox Virus Antigen Rapid Test can be performed using Skin lesion Swab or Mucous membrane Swab.

Skin lesion Swab: Place the sterile swab onto the skin lesion site, especially the part with vesicles. Gently scrape the lesion to collect the fluid for 5~8 times with the swab.

Mucous membrane Swab: Place the head of sterile swab into the deep throat, or the nasal cavities, or onto the eye conjunctiva. Gently scrape the mucous membrane with the swab for 5~8 times .

Insert the swab into the provided assay buffer tube.Stir for 8-10 times and stand for one minute.

The assay should be performed immediately in 2 hours after the specimen preparation. If the assay could not be carried immediately, the prepared specimen should be kept no more than 24 hours at 2-8°C or 7 days at -20°C.  

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than two times.

If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.

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) Sterile 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. Suck the treated sample extraction from the assay buffer tube and place 3 drops into the sample hole “S” of the test device. and start the timer.

Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

PERFORMANCE CHARACTERISTICS

1. Cross-reactivity

No cross reaction was observed when samples enriched with the following respiratory symptoms relative pathogens: Influenza A, Influenza B, Human coronavirus (229E, HKU1, OC43 and NL63), Parainfluenza virus (type 1-4), Sars-CoV-2 virus (alpha, beta, delta, omicron variants), Mycoplasma pneumoniae, adenovirus, respiratory syncytial virus, Neisseria meningitidis, mumps virus, Staphylococcus aureus, Streptococcus pneumoniae.

2. Interfering Substances: 

No interference was observed to the test strip, with the following compounds: Alpha-interferon, purified Mucin, whole blood, budesonide nasal spray, Dexamethasone, Oxymetazoline, HAMA, Fluticason propionate.

3.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.