Monkeypox Virus Ag Test Kit (Colloidal Gold)

Product Name

Monkeypox Virus Ag Test Kit (Colloidal Gold)

Product Description

The Monkeypox Virus Ag Test Kit is a gold immuno-chromatographic assay (GICA) that is intended for the qualitative detection of the nucleocapsid protein antigen from Monkeypox Virus in oropharyngeal swaband saliva specimens directly from individuals who are suspected of Monkeypox Virus by their healthcare provider, with or without signs and symptoms of Monkeypox Virus. Results are for the identification of Monkeypox Virus nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected

may not be the definite cause of disease. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out Monkeypox Virus and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with Monkeypox Virus.

The Monkeypox Virus Ag Test Kit is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.

Storage and Expiry Date

1.Kits should be stored in 2°C~30°C, valid for 12 months. Do not freeze.

2. The test Cassette should be used within 2 hour once it has been removed from the foil pouch.

3. Keep away from sunlight, moisture, and heat.

4. Kit components are stable until the expiration date printed on the outer box.

SPECIMEN COLLECTION AND PREPARATION

Test specimens immediately after collection for optimal test performance. Inadequate specimen collection or improper sample handling/storage/transport may yield erroneous results.

Collection of nasal swab specimen:

1. Collection of oropharyngeal swab specimen:

2. Collection of saliva specimen:

SAMPLE TRANSPORT AND STORAGE

Samples should be tested as soon as possible after collection. The nasal or nasopharyngeal swabs are stable for up to 24 hrs at room temperature or 2- 8°C.

TEST PROCEDURE

Please read the instructions for use carefully before testing, and complete the test in strict accordance with the directions of the manual, otherwise reliable results

cannot be guaranteed.

Open the aluminum foil bag, put the test Cassette on a clean, horizontal bench.

Bring the samples to room temperature prior to assay in case of the samples were stored at 2- 8°C.

INTERPRETATION OF TEST RESULTS

1. Positive: A red line appears on the test line (T) and the control line (C).

NOTE: A positive result does not rule out co-infections with other pathogens.

2. Negative:Only the control line (C) appears, and no red line appears on the test line (T).

NOTE: A negative result does not exclude infection.

1. Invalid:There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again.

Scope of Use

EU countries and countries that recognize the EU CE certification.

Product Features

1. Specimen: Nasal / Throat l Anterior Nasal swab

2. Simple operation

3. Convenient storage: 2-30°c

Our advantage

1. Quick result: ＜10 minutes

2. High accuracy: ＞95%

3. High sensitivity：>99%