NOVAtest LOGO

Menu Search

TB Test Kits

TB Correlative IFN-γ Release Assay (TB-IGRA) and traditional TB rapid test kits are supplied.

TB-IGRA ELISA Kit

TB Rapid Test Kits

Tuberculosis rapid test cassette, also called one-step TB test kit, is a lateral flow chromatographic immunoassay (CIA) kit; and TB Dot assay kit is an immuno dot filtration assay kit; both of these POCT test kits are for the direct qualitative detection of tuberculosis antibodies in human serum or plasma specimen.

Tuberculosis (TB) Rapid Test Kit

These TB rapid test kits are widely used as an aid in the diagnosis of infection due to Mycobacterium tuberculosis, because they are easy to perform, and takes as short as minutes to get the testing results, instead of waiting for days for the testing result with other complicated testing methods.

TB Correlative IFN-γ Release Assay (TB-IGRA)

TB-IGRA is an ELISA kit for the quantitative detection (2~400pg/ml) of Interferon Gamma (IFN-y) that respond to in-vitro stimulation by Mycobacterium tuberculosis antigens in human whole blood. It is intended for use as an aid in the diagnosis of tuberculosis (TB) infection, including both latent tuberculosis infection (LTBI) and tuberculosis (TB) disease.

Merits of TB-IGRA ELISA kit

IGRA measures a person's immune reactivity to M.tuberculosis. When infected with Mycobacterium tuberculosis, specific T-lymphocytes will appear in the blood of the patient, which will be stimulated to proliferate and release cytokines such as IFN-γ, when they are mixed with antigens derived from M.Tuberculosis. The concentration of IFN-γ is positively related with the quantity of tuberculosis antigens.

The antigens selected for stimulation is specific fragments that pathogenic Mycobacterium tuberculosis contains, while BCG vaccine and other Mycobacterium don't contain. This greatly improves the specificity of the TB-IGRA Assay kit. And this

TB Assay kit is easier to operate than PCR, bacterial culture and SPOT. And this TB-IGRA ELISA kit can be used in the following realms:

  • Active tuberculosis detection;
  • Latent tuberculosis detection;
  • TB therapeutic effect monitor;
  • Medication instruction;
  • Prevent TB cross infection.

Tuberculosis

Tuberculosis is a highly infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis (MTB or TB). It is a small bacillus that can withstand weak disinfectants and can survive in a dry state for weeks. TB is transmitted almost exclusively by aerosol from the respiratory secretions of patients with active M. tuberculosis.

Most of the infected will keep asymptomatic, and about 10% progress to active disease. Tuberculosis mainly affects the lungs and about 80% of all cases of tuberculosis were limited to the lungs. Extra-pulmonary cases most happen to immunosuppressed patients. It was reported that half of the patients can be killed by the TB infection, if not treated with antibiotics. Morbidity of tuberculosis has been decreasing, but recently HIV–associated tuberculosis and multi-drug resistant tuberculosis are on the rise. Persons with silicosis have an approximately 30-fold greater risk for TB infection.

As present, Tuberculosis remains an important socio-economical and medical problem throughout the world. The early detection of tuberculosis disease will help to reduce and chance of further spread, and will help to the cure of the infected. In this way, the IVD Tuberculosis (TB) testing devices are contributing to the control of tuberculosis disease.

Tuberculosis Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
TB 811 TB AB Serum Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
TB 812 TB IgG/IgM WB Test Cassette serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
TB 8112 Tuberculosis IgG Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
TB 8124 TB IgG ELISA Kit serum/WB 96 Boxed: 40 Kits
TB 8134 TB Correlative IFN-γ Release Assay serum/WB 96 Boxed: 40 Kits
How to Use

TB AB Serum Test Cassette

General Information

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

Catalog No.:TB 811
Description:TB AB Serum Test Cassette
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:95.9%
Specificity:90%
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

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 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

TB IgG/IgM WB Test Cassette

General Information

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

Catalog No.:TB 812
Description:TB IgG/IgM WB Test Cassette
Category:Respiratory Tract Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:95.9%
Specificity:90%
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

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/WB/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

Tuberculosis IgG Dot Assay

General Information

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

Catalog No.:TB 8112
Description:Tuberculosis 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

TB IgG ELISA Kit

General Information

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

Catalog No.:TB 8124
Description:TB IgG ELISA Kit
Category:Respiratory Tract Disease
Style:Microwell
Unit:Box
Specimen:serum/WB
No. of Step:Two Step
Reading Time:60-15 Minutes
Cut Off:
Specification:96T
Quan. or Qual.:Qualitative
Sensitivity:89%
Specificity:93%
Method:Indirect ELISA

Packing Specification

Tests per Kit:96 Tests
Box Dimension:13.5 * 9.0 * 8.0 CM
Kits per CTN:40 Kits
Carton Dimension:59 * 45 * 38 CM
Tests per CTN (BULK):40 Tests
Carton Volume:0.100 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • MICROWELL PLATE: 1 plate;
  • NEGATIVE CONTROL: 1 vial;
  • POSITIVE CONTROL SERUM: 1 vial;
  • SPECIMEN DILUENT: 1 vial;
  • HRP-CONJUGATE REAGENT: 1 vial;
  • WASH BUFFER: 1 bottle;
  • CHROMOGEN SOLUTION A: 1 vial;
  • CHROMOGEN SOLUTION B: 1 vial;
  • STOP SOLUTION: 1 vial;
  • PLASTIC SEALABLE BAG: 1 piece;
  • CARDBOARD PLATE COVER;
  • PACKAGE INSERTS: 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.

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.

serum/WB 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 Indirect ELISA

ELISA Indirect Method Illustration

With indirect ELISA kit, polystyrene microwell strips are pre-coated with purified or recombinant viral antigens.

The antibody detection is achieved in two steps. During the first incubation step, the target antibodies, if present, will be bound to the solid phase pre-coated antigens.

The wells are washed to remove unbound serum proteins, and rabbit anti-human IgG antibodies (anti-IgG) conjugated to horseradish peroxidase (HRP) are added. During the second incubation step, these HRP-conjugated antibodies will be bound to any antigen-antibody complexes previously formed.

Then the unbound HRP-conjugate is then removed by washing. Chromogen solutions containing Tetramethyl benzidine (TMB) and urea peroxide are added to the wells. In presence of the antigen-antibody-anti-IgG (HRP) immuno complex, the colorless Chromogens are hydrolyzed by the bound HRP conjugate to a blue colored product which turns blue color turns yellow after stopping the reaction with sulfuric acid, indicating a positive result.

Wells containing samples negative for the target antibodies remain colorless.

Information | Packing | Specimen | Principle

TB Correlative IFN-γ Release Assay

General Information

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

Catalog No.:TB 8134
Description:TB Correlative IFN-γ Release Assay
Category:Respiratory Tract Disease
Style:Microwell
Unit:Box
Specimen:serum/WB
No. of Step:One Step
Reading Time:10 min-16 Hour
Cut Off:
Specification:---
Quan. or Qual.:Quantitative
Sensitivity:89%
Specificity:93%
Method:Double Antibody Sandwich ELISA

Packing Specification

Tests per Kit:96 Tests
Box Dimension:13.5 * 9.0 * 8.0 CM
Kits per CTN:40 Kits
Carton Dimension:59 * 45 * 38 CM
Tests per CTN (BULK):40 Tests
Carton Volume:0.100 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • MICROWELL PLATE: 1 plate;
  • NEGATIVE CONTROL: 1 vial;
  • POSITIVE CONTROL SERUM: 1 vial;
  • SPECIMEN DILUENT: 1 vial;
  • HRP-CONJUGATE REAGENT: 1 vial;
  • WASH BUFFER: 1 bottle;
  • CHROMOGEN SOLUTION A: 1 vial;
  • CHROMOGEN SOLUTION B: 1 vial;
  • STOP SOLUTION: 1 vial;
  • PLASTIC SEALABLE BAG: 1 piece;
  • CARDBOARD PLATE COVER;
  • PACKAGE INSERTS: 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.

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.

serum/WB 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 Double Antibody Sandwich ELISA

ELISA Double Antibody Sandwich Method Illustration

With this type of ELISA test kits, the detection target usually is hormone protein or viral antigen.

In the test kit, monoclonal or polyclonal antibodies specific to the target protein or antigen are used as capturer, which are pre-coated on the polystyrene microwell strips. The sample from the patient, such like urine, serum or plasma sample is added to the microwells. And a second antibody conjugated with horseradish peroxidase (HRP) is used as the detector, which then is added to the microwells. Usually, the samples and the second antibody conjugate are added to the microwell in the same time, thus it is a one-step assay process.

During incubation, the specific immuno-complex formed in case of presence of the target antigen or protein in the sample, and is captured on the solid phase.

After washing to remove sample serum proteins and unbound HRP-conjugate, Chromogen solutions containing tetramethyl benzidine (TMB) and urea peroxide are added to the wells. In presence of the antibody-antigen-antibody (HRP) "sandwich" immuno complex, the colorless Chromogens are hydrolyzed by the bounded HRP-conjugate to a blue colored product. The blue color turns yellow after stopping the reaction with sulfuric acid, indicating a positive result. The amount of color can be measured and is proportional to the amount of antigen or protein in the sample.

Wells containing samples negative for the target antigen or protein remain colorless.

Information | Packing | Specimen | Principle