Monkeypox Virus Antigen Test Kit

Main technical information of this Monkeypox Ag test kit is listed in the following table:

Former Cat. No.:	MPV 231
Description:	Monkeypox Virus Antigen Test Kit
Category:	Respiratory Tract Disease
Style:	Card
Unit:	PCS
Specimen:	Serum, plasma, whole blood, nasopharyngeal swab, lesion exudate & saliva
No. of Step:	One Step
Reading Time:	15 Minutes
Cut Off:
Specification:	4.0 mm
Quan. or Qual.:	Qualitative
Sensitivity:	98%
Specificity:	99%
Assay Principle:	Colloidal Gold Chromatographic Immuno Double Antibody Sandwich

The standard kit size of this Monkeypox Disease Card test kit is 20 tests per box; 55 boxes per carton.

To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.

Tests per Kit:	20 Tests
Dimension of Kit Box:	15.5 * 12.5 * 6.5 CM
Boxes per Carton:	55 Kits
Tests per Carton (BULK):	1200 Tests
G.W. per Carton (Boxed):	12.5 KG
G.W. per Carton (Bulk):	14.5 KG
Carton Dimension:	53 * 44 * 35 CM
Carton Volume:	0.082 CBM

Materials Provided

• Test Cassette (20×)
• Assay Diluent (2×) [5mL/bottle]
• Disposable Extraction Dropper (20×)
• Specimen Transfer Pipette (20×)
• Sterile Sampling Swab (20×)
• Instruction For Use (1×)

To carry out the assay with a Monkeypox Virus Antigen Test Kit, should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.

Serum/Plasma Collection

Collect blood specimen into collection tube containing EDTA, citrate or heparin for plasma or collection tube containing no anticoagulants for serum by venepuncture.

Test specimens as soon as possible after collecting. Store specimens at 2-8°C if not tested immediately. Specimens can be stored at 2-8°C for up to 3 days and should be frozen at -20°C for longer storage.

Avoid multiple freeze-thaw cycles (no more than 3 times). Prior to testing, equilibrate frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross haemolysis or turbidity to avoid interference on result interpretation.

Blood Collection With Lancet

Collect whole blood by either fingertip puncture or by venepuncture into collection tube containing EDTA, citrate or heparin for plasma.

Do not use any haemolyzed blood for testing.

Do not freeze a whole blood specimen, otherwise the red blood cell will break and causes haemolysis. Whole blood specimens should be stored in refrigeration (2-8°C) if not tested immediately. The specimens must be tested within 24 hours after collection.

Nasopharyngeal Swab Collection

To collect a nasopharyngeal swap sample, carefully insert the swab into the nostril that presents the most secretion under visual inspection.

Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx.

When the tip of the swab reaches the posterior wall of the nasopharynx cavity, gently rotate the swab several times then remove it from the nasopharynx.

Lesion Exudate Collection

Have the patient leak the affected area of the suspected monkeypox infection.

Take the swab and rub it back and forth along the affected area four times, then turn the swab to the opposite side, and using the opposite side of the swab, rub back and forth along the affected area four times.

Saliva Collection

Do NOT eat, drink, smoke, or chew gum for 30 minutes before saliva collection procedure.

Severe mouth ulcers and bronchitis may affect the collection Contact infection should be avoided from different tested ones. Using running water to clean mouth 30 minutes before saliva collection.

Insert the synthetic flocking head plastic rod swab into the mouth, slowly wipe the oral upper palate and the inside of the left and right cheeks and hold it in the mouth for a while until the swab is completely saturated with the saliva. Withdraw the swab from the mouth.

Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this Monkeypox Virus Antigen Test Kit to detect the Monkeypox Virus Antigen in human specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antibody Sandwich testing principle is given blow.

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.