Chlamydia Trachomatis IgM Assay
Chlamydia Trachomatis IgM Assay kit (沙眼衣原体（CTm）IgM抗体渗滤法检测试剂) is a two-step qualitative dot filtration rapid diagnostic test kit, based on the Colloidal Gold Immuno-filtration Capture principle, which is used to detect Chlamydia Trachomatis IgM Antibody in human Serum specimen.
Please refer to the Instruction for Use (IFU) of the Chlamydia Trachomatis IgM Assay kit.
Detailed information of Chlamydia Trachomatis IgM Assay
- General and Technical information of this CTm test kit;
- Packing specification of this CTm DOT Card style test kit (gross weight in full kit package and in bulk packing);
- Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
- Specific immuno assay principle used in this Chlamydia Trachomatis Test Kit.
Main technical information of this CTm IgM test kit is listed in the following table:
|Catalog No.:||CHLA 3422|
|Description:||Chlamydia Trachomatis IgM Assay|
|Category:||Sexually Transmitted Disease|
|No. of Step:||Two Step|
|Reading Time:||3 Minutes|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Colloidal Gold Immuno-filtration Capture|
The standard kit size of this Chlamydia Trachomatis DOT Card test kit is 25 tests per box; 36 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:||36 Kits|
|Tests per Carton (BULK):||1200 Tests|
|G.W. per Carton (Boxed):||15.0 KG|
|G.W. per Carton (Bulk):||15.0 KG|
|Carton Dimension:||53 * 45 * 36 CM|
|Carton Volume:||0.085 CBM|
- Filtration assay device;
- Washing buffer Gold colloidal Conjugate solution;
- Disposable dropper for sample transfer;
- Instruction For Use (IFU).
To carry out the assay with a Chlamydia Trachomatis IgM Assay, 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.
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 Immuno-filtration Capture method is used in this Chlamydia Trachomatis IgM Assay to detect the Chlamydia Trachomatis IgM Antibody in human Serum specifically. The introduction of this Colloidal Gold Immuno-filtration Capture testing principle is given blow.
For the detection of IgM-class antibodies, capture technique has its advantage in that it can reduce the interference from the IgG class, thus increase the specificity of the test kit.
In a capture dot filtration test kit, antibodies directed to human IgM antibody (anti-i chain) are pre-coated in the test region on the millipore filtering membrane. When specimen is added, the IgM, if present, will be captured by this secondary antibody, anti-IgM.
After washing away the specimen, especially the IgG antibody, the antigen conjugated with colloidal gold particle will be added. If the IgM antibody was captured in the prior step, the IgM will bind to the antigen conjugate. When the colloidal gold particles congregate, a red or pink color will develop, indicating a positive result.
If no IgM in the specimen, this complex will not develop, the antigen conjugated colloidal gold particles will not congregate, and no color will develop in the test region, indicating a negative result.