Rubella IgM Antibody Test Cassette

Rubella IgM Antibody Test Cassette (风疹IgM抗体检测试纸) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Capture principle, which is used to detect Rubella Virus IgM Antibody in human Serum specimen.

Please refer to the Instruction for Use (IFU) of the Rubella IgM Antibody Test Cassette. (For reference only; Read the package insert in the test kit before performing any test.)

Detailed information of Rubella IgM Antibody Test Cassette

  1. General and Technical information of this RV test kit;
  2. Packing specification of this RV Card style test kit (gross weight in full kit package and in bulk packing);
  3. Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
  4. Specific immuno assay principle used in this Rubella Virus Test Kit.

Main technical information of this Rubella IgM test kit is listed in the following table:

Catalog No.:RuV 161
Description:Rubella IgM Antibody Test Cassette
Category:Fetility & Eugenics
Style:Card
Unit:PCS
Specimen:Serum
No. of Step:One Step
Reading Time:15-30 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:95.3%
Specificity:96%
Assay Principle:Colloidal Gold Chromatographic Immuno Capture

The standard kit size of this Rubella Virus Card test kit is 25 tests per box; 40 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:25 Tests
Dimension of Kit Box:21.0 * 12.5 * 6.5 CM
Boxes per Carton:40 Kits
Tests per Carton (BULK):1600 Tests
G.W. per Carton (Boxed):14.0 KG
G.W. per Carton (Bulk):16.5 KG
Carton Dimension:53 * 45 * 36 CM
Carton Volume:0.085 CBM

Materials Provided

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Instruction leaflet.

To carry out the assay with a Rubella IgM Antibody Test Cassette, Serum 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.

Serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. 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.

Colloidal Gold Chromatographic Immuno Capture method is used in this Rubella IgM Antibody Test Cassette to detect the Rubella Virus IgM Antibody in human Serum specifically. The introduction of this Colloidal Gold Chromatographic Immuno Capture testing principle is given blow.

GICA Capture Method Illustration

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.