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CMV Rapid Test Kits

CMV IgG test and CMV IgM test kits are used in the diagnosis of Cytomegalovirus infection.

CMV IGG and IgM cards

Intended Use

Atlas Link Technology Co. Ltd is supplying two series of Cytomegalovirus test kits according to the testing methods, namely one-step lateral flow CMV rapid test kits, and CMV Dot Filtration Assay kits. Both can be divided into two types depending on the isotypes of the antibody tested:CMV IgM test kits and CMV IgG test kits.

All the CMV rapid assay kits are based on the principle of Gold Immuno-chromatography Assay (GICA), using the antibody-antigen reaction to detect CMV IgM and IgG antibodies in human serum or plasma specimen respectively, and are used in the diagnosis of Cytomegalovirus infection.

Why CMV Test Matter

The detecting of CMV IgM antibody enables effective diagnosis of acute or recent CMV infection. The test is particularly useful for the follow-up of pregnant women, who were not previously exposed to CMV and consequently are not protected against the virus. In addition, determination of specific IgM antibody in the newborn is useful for the diagnosis of congenital CMV infection. Screening for IgG antibodies to CMV is useful to detect previous exposure to CMV. By detecting the Cytomegalovirus specific antibodies in serum samples, and by differentiating the IgM and IgG antibodies, these two CMV antibody tests can help to determine the immune status and the infection status of the patient, thus Cytomegalovirus tests help disease administration properly.

Testing Principle

These Cytomegalovirus tests are IVD test, and the assay principle are similar. With one-step CMV IgM rapid test, e.g. when serum is added,the CMV-IgM antibody will react with anti-human IgM monoclonal antibody embedded in the sample well. These complexes move along the membrane strip chromatographically to the test region (T), where these complexes will be captured by the pre-coated recombinant CMV antigen. Then a red or pink line will develop, indicating a positive result. C line should always appear, as a inner control indicator.

Cytomegalovirus Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
CMV 151 Cytomegalovirus IgM Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
CMV 152 Cytomegalovirus IgG Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
CMV 1512 Cytomegalovirus IgM Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
CMV 1522 Cytomegalovirus IgG Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
How to Use

Cytomegalovirus IgM Cassette

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:CMV 151
Description:Cytomegalovirus IgM 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:
Specificity:
Method:Lateral Flow Capture

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

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 Lateral Flow Capture

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.

Information | Packing | Specimen | Principle

Cytomegalovirus IgG Cassette

General Information

(IVD Kit »-» Fetility & Eugenics -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:CMV 152
Description:Cytomegalovirus IgG 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:
Specificity:
Method:Lateral Flow Indirect

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

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 Lateral Flow Indirect

GICA Indirect Method Illustration

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.

As a procedural quality control, a secondary antibody or recombinant antigen will be immobilized in the control band region. When the specimen climb to this region, the unbound anti-IgG colloidal gold particle will be captured, thus a red band will always develop. This inner control process ensure that enough specimen is added, proper testing procedure has been followed, and the reagent has not deteriorated.

Information | Packing | Specimen | Principle

Cytomegalovirus IgM Dot Assay

General Information

(IVD Kit »-» Fetility & Eugenics -» Dot Immuno Gold Filtration Assay)

Catalog No.:CMV 1512
Description:Cytomegalovirus IgM Dot Assay
Category:Fetility & Eugenics
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

Cytomegalovirus IgG Dot Assay

General Information

(IVD Kit »-» Fetility & Eugenics -» Dot Immuno Gold Filtration Assay)

Catalog No.:CMV 1522
Description:Cytomegalovirus IgG Dot Assay
Category:Fetility & Eugenics
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