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Mycoplasma Pneumonia Test Kits

Different types of Mycoplasma Pneumonia rapid test kits, used as an aid in the diagnostics of Mycoplasma Pneumoniae infections.

Mycoplasma Antibody Rapid Test Kits

Intended Use

Atlas Link Technology Co., Ltd supplies different Mycoplasma Pneumonia rapid test kits: M.Pneumonia IgM Rapid test, M.Pneumonia IgM &IgG Dot ELISA kit, and M.Pneumonia IgG & IgM dot assay filtration test kit. These M.Pneumonia test kits are intended to be used to detect M.Pneumonia antibodies (IgG or IgM) qualitatively, and are widely used as screening test device and as an aid in the diagnostics of Mycoplasma Pneumoniae disease.

Because these M.Pneumonia test kits are all easy to perform, they are widely used as screening test devices and as an aid in the diagnostics of Mycoplasma Pneumoniae disease.

Testing Principle

In these Mycoplasma rapid test kits, purified monoclonal Mycoplasma antigen are used to detect IgG or IgM antibodies specifically, based on the principle of antibody and antigen immuno binding principle.

E.g., in a mycoplasma rapid test cassette, when the serum sample is added to the sample well, if it contains M.Pneumonia antibody, the antibody will react and bind with the anti-human M.Pneumonia antibody embedded in the sample well region. Then the complexes move on to the test region (T) chromatographically, where the pre-coated recombinant MP antigen will capture the complexes by binding to the binding site on the antibody. The cumulation of the colored colloidal gold particle will develop a red or pink line in the test region, indicating a positive result.

Mycoplasma pneumonia

Mycoplasma pneumonia is an important etiological agent of community acquired infections of upper and lower respiratory tracts, which is mainly atypical pneumonia. More mycoplasma pneumonia positive cases were observed between spring and early summer; and more common in elders over 70 years old, especially among those over 80 years old.

The identification of the antibodies specific to M.pneumoniae virus will help the administration of the disease with appropriate antibiotic treatment. This M.Pneumonia (MP) immunoassay of is intended to detect M.Pneumonia antibodies qualitatively.

Mycoplasma Pneumonia Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
MP 841 Mycoplasma Pneumoniae IgM Test Casse serum/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
MP 8412 Mycoplasma Pneumoniae IgM Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
MP 8422 Mycoplasma Pneumoniae IgG Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
MP 8413 Mycoplasma Pneumoniae IgM DOT-ELISA serum 48 Bulk: 42 PCS
Boxed: 42 Boxes
MP 8423 Mycoplasma Pneumoniae IgG DOT-ELISA serum 48 Bulk: 42 PCS
Boxed: 42 Boxes
How to Use

Mycoplasma Pneumoniae IgM Test Casse

General Information

(IVD Kit »-» Respiratory Tract Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:MP 841
Description:Mycoplasma Pneumoniae IgM Test Casse
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:serum/plasma
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99%
Specificity:97.5%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

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

Specimen

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 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/plasma Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 3 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.

Testing Principle of Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen 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 antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold 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 antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Mycoplasma Pneumoniae IgM Dot Assay

General Information

(IVD Kit »-» Respiratory Tract Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:MP 8412
Description:Mycoplasma Pneumoniae IgM Dot Assay
Category:Respiratory Tract Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA Capture

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

Specimen

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.

Testing Principle of DGFIA Capture

DGFIA Capture Method Illustration

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.

Information | Packing | Specimen | Principle

Mycoplasma Pneumoniae IgG Dot Assay

General Information

(IVD Kit »-» Respiratory Tract Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:MP 8422
Description:Mycoplasma Pneumoniae IgG Dot Assay
Category:Respiratory Tract Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

Specimen

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.

Testing Principle of DGFIA indirect

DGFIA Indirect Method Illustration

With indirect Dot filtration test kit, the millipore filtering membrane is pre-coated with purified or recombinant viral antigens. The detecting conjugate reagent is stored in a vial, whose main component is rabbit anti human IgG (anti-IgG) antibodies, which is conjugated with colloidal gold particles.

During the first step, sample is added to the sample well in the test cassette. The target IgG antibodies, if present, will be captured by the pre-coated antigens.

The wells are washed to remove unbound serum proteins. Then, the colloidal gold conjugate is added. If the target IgG antibodies have been captured in the first step, the IgG antibody will react with the added secondary antibody, anti-IgG conjugate, and red color will develop, indicating a positive result.

Information | Packing | Specimen | Principle

Mycoplasma Pneumoniae IgM DOT-ELISA

General Information

(IVD Kit »-» Respiratory Tract Disease -» Dot Enzyme Linked Immunoadsorbent Assay)

Catalog No.:MP 8413
Description:Mycoplasma Pneumoniae IgM DOT-ELISA
Category:Respiratory Tract Disease
Style:DOT ELISA
Unit:Box
Specimen:serum
No. of Step:Two Step
Reading Time:10-2-2-3 Minutes
Cut Off:
Specification:24T/36T/48T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Dot ELISA Capture

Packing Specification

Tests per Kit:48 Tests
Box Dimension:13.5 * 9.0 * 8.0 CM
Kits per CTN:42 Kits
Carton Dimension:55 * 44 * 35 CM
Tests per CTN (BULK):42 Tests
Carton Volume:0.084 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Immuno-filtration device in pouch with desiccant, with an integrated sample flow controller;
  • HRP-conjugate: 1 dropper bottle of 2ml;
  • Sample preservation buffer: 6ml;
  • Wash Buffer: 1 dropper bottle of 6ml;
  • Chromogen Solution: 1 bottle of 1ml;
  • Stop Solution: 1 dropper bottle of 1ml;
  • Sample collection tube: 6 tubes/kit;
  • Sample Lysis Bottle: 6 pieces/kit;
  • Measuring Pipette: 6 pieces/kit;
  • Plastic sealable bag: 1pcs (store the cards not in use);
  • Instruction for use: 1 copy.

Specimen

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.

Testing Principle of Dot ELISA Capture

Dot ELISA Capture Method Illustration

IgM-class antibodies usually are connected with primary infections or acute infections, their diagnosis has a special meaning to the clinical diagnosis. In order to avoid false positive caused by the IgG class, capture testing method is often used to detect IgM antibodies.

In capture dot ELISA kit, millipore filtering membrane (usually nitrocellulose,NC) is pre-coated with secondary antibodies directed to human IgM (anti-μ chain) in test dot area. The patient’s serum/plasma sample is added to the membrane, which filtrates through the latter. During the minutes of filtration process, the IgM antibodies, if present, will be captured by the immobilized anti-IgM antibodies, while IgG antibodies will not.

The IgG antibodies will be washed away completely after wash buffer is added.

Then, viral antigens conjugated to horseradish peroxidase (HRP) are added, which will specifically react with the captured viral specific IgM antibodiesn and antigen conjugate will be captured.

After washing to remove unbound conjugates, Chromogen solutions are added to the membrane, then stop solution is added. When HRP present, the colorless chromogens are hydrolyzed to a blue color product at the testing dot area, indicating a positive result.

Information | Packing | Specimen | Principle

Mycoplasma Pneumoniae IgG DOT-ELISA

General Information

(IVD Kit »-» Respiratory Tract Disease -» Dot Enzyme Linked Immunoadsorbent Assay)

Catalog No.:MP 8423
Description:Mycoplasma Pneumoniae IgG DOT-ELISA
Category:Respiratory Tract Disease
Style:DOT ELISA
Unit:Box
Specimen:serum
No. of Step:Two Step
Reading Time:10-2-2-3 Minutes
Cut Off:
Specification:24T/36T/48T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:Dot ELISA Indirect

Packing Specification

Tests per Kit:48 Tests
Box Dimension:13.5 * 9.0 * 8.0 CM
Kits per CTN:42 Kits
Carton Dimension:55 * 44 * 35 CM
Tests per CTN (BULK):42 Tests
Carton Volume:0.084 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Immuno-filtration device in pouch with desiccant, with an integrated sample flow controller;
  • HRP-conjugate: 1 dropper bottle of 2ml;
  • Sample preservation buffer: 6ml;
  • Wash Buffer: 1 dropper bottle of 6ml;
  • Chromogen Solution: 1 bottle of 1ml;
  • Stop Solution: 1 dropper bottle of 1ml;
  • Sample collection tube: 6 tubes/kit;
  • Sample Lysis Bottle: 6 pieces/kit;
  • Measuring Pipette: 6 pieces/kit;
  • Plastic sealable bag: 1pcs (store the cards not in use);
  • Instruction for use: 1 copy.

Specimen

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.

Testing Principle of Dot ELISA Indirect

Dot ELISA Indirect Method Illustration

IgG-class antibodies usually are connected with secondary infections, and will usually remain in the human body fluid for a long time. Usually, indirect method is used to test this class of antibodies.

In indirect dot ELISA kit, millipore filtering membrane (usually nitrocellulose,NC) is pre-coated with recombinant or purified antigen, which acts as capturer. And a secondary antibody, such as goat anti-mouse IgG antibody (anti-IgG), is made into conjugate reagent by conjugate this second antibody with horseradish peroxidase (HRP). This conjugate acts as indicator.

When the patient’s fluid sample is added to the membrane, it will filtrate through the latter. During the minutes of filtration process, the IgG and other isotypes of antibodies, if present, will be captured by the immobilized antigen. The unbound specimen is washed away completely after wash buffer is added.

Then, anti-IgG conjugate reagent is added, which will specifically interact with the captured IgG antibodies.

And Ag-ab-anti-IgG complex will develop, at which end is the HRP.

After washing to remove unbound conjugates, Chromogen solutions are added to the membrane, then stop solution is added. When HRP presents, the colorless chromogen is hydrolyzed to a blue color product at the testing dot area, indicating the specimen is IgG positive.

Information | Packing | Specimen | Principle