Monkeypox virus IgG/IgM joint Test

Main technical information of this Monkeypox IgG/IgM test kit is listed in the following table:

Former Cat. No.:	MPV 233
Description:	Monkeypox virus IgG/IgM joint Test
Category:	Respiratory Tract Disease
Style:	Card
Unit:	PCS
Specimen:	Serum, whole blood, plasma
No. of Step:	One Step
Reading Time:	15 Minutes
Cut Off:
Specification:	4.0 mm
Quan. or Qual.:	Qualitative
Sensitivity:	97.3%
Specificity:	99.2%
Assay Principle:	Capture for IgM, Indirect for IgG

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):	13.3 KG
G.W. per Carton (Bulk):	14.5 KG
Carton Dimension:	53 * 44 * 35 CM
Carton Volume:	0.082 CBM

Materials Provided

• Test Cassettes (20×)
• Assay Diluent [5ml/bottle] (1×)
• Alcohol Prep Pad (20×)
• Sterile Disposable Self-spring Lancet (20×)
• Blood Transfer Pipette (20×)
• Instruction For Use (IFU)(1×)

To carry out the assay with a Monkeypox Virus IgG/IgM Joint Test, Serum, whole blood or plasma 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 Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

Serum, Whole Blood, Plasma Storage Condition

Test specimens as soon as possible after collecting.

The serum and plasma specimens can be stored up to 3 days at 2-8°C if not tested immediately. These specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times.

Whole blood specimens (from venepuncture or fingerstick) should be stored at 2~8°C and must be tested within 24 hours after collection. Do not freeze a whole blood specimen.

Prior to testing, bring 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 hemolysis or turbidity in order to avoid interference on result interpretation.

Capture for IgM, Indirect for IgG method is used in this Monkeypox Virus IgG/IgM Joint Test to detect the Monkeypox IgG/IgM Antibodies in human Serum, whole blood or plasma specifically. The introduction of this Capture for IgM, Indirect for IgG testing principle is given blow.

1. For the detection of IgM-class antibodies, in order to avoid the interference from the IgG class, capture assays technology is usually the best choice.

In capture lateral flow test kit, a secondary antibody, usually antibody directed to human IgM (anti-human IgM), is immobilized in the test band region on the strip membrane. And monoclonal viral antigen or protein conjugated with colloidal gold particle is embedded in the end of membrane strip.

During the testing process, the sample is added to the end of the membrane strip, the embedded antigen conjugate will resolve into the sample, where the target IgM antibody, if present, will react with and bound to the antigen conjugated with colloidal gold particles.

When the IgM-antigen complex moves to the test band region under the capillary effect, the IgM antibody will be captured by the immobilized anti-human IgM antibody. When the colloidal gold particles congregate in the test band region, a red or pink color will develop, indicating a positive result.

If there is no IgM antibody in the specimen, the antigen conjugated with colloidal gold particle can’t be captured by the anti-human IgM secondary antibody, and no color will develop, indicating a negative result.

2. IgG Indirect: In the lateral flow indirect chromatographic rapid test, recombinant or purified antigens are immobilized in the test band region. In the end of the Conjugate pad of the membrane strip where the samples are supposed to be added, rabbit or mouse anti-human IgG antibodies conjugated with colloidal gold particles is embedded.

During the testing process, specimen is added to the end of the membrane strip. anti-IgG colloidal gold particles resolve into the specimen, where the anti-IgG conjugate will react and bound with the target IgG antibody, if present.

This complex of IgG and anti-IgG will move along the membrane strip to the testing band region, under capillary effect, where the immobilized antigen captures the IgG antibody. When the antigen-IgG-Anti-IgG complex accumulate on the test band region, the congregated colloidal gold particle will develop red or pink color, indicating there are target IgG antibodies in the specimen.

If there is no target IgG antibody in the specimen, the secondary anti-IgG conjugate will not bind to the immobilized antigen in the test band region, and no color will develop.