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Influenza A & B Rapid Test Kits

Influenza A & B antigen swab test kits, Influenza-A IgM test, and Influenza-B IgM test are intended to be used in the diagnosis of influenza A and B viral infections.

Influenza A and Influenza B POCT Rapid Test Kits

Intended Use

Influenza A/B test strip is an in-vitro immunoassay based on the principle of lateral flow Chromatographic Assay, for the qualitative detection of Influenza A and B nucleoproteins in various swab specimens such as throat swab, nasal swab. Influenza A IgM Dot Assay Kit and Influenza B IgM Dot Assay Kit are dot assay rapid test kits, for the qualitative detection of IgM antibodies specific to influenza A and B respectively in human serum specimen.

All these kits are intended to be used to help the diagnosis of influenza A and B viral infections.

Testing Principle

One step Influenza Rapid test, influenza dot assay and Influenza DOT ELISA are all In-Vitro immunoassay devices, with a little difference in the color development principle. In the rapid influenza antigen test, antibodies specific to the Influenza A and Influenza B nucleoproteins is separately coated on the test line regions of the test strip. During testing, the nucleoproteins, if present in the specimen, will react with the Mouse monoclonal anti-influenza B-gold colloid or anti-influenza A-Gold Colloid. The mixture migrates up the membrane and captured by the antibodies to Influenza A and/or Influenza B on the membrane, and the accumulation of the colloidal gold conjugate will present colored lines in the test regions, indicating a positive result.

Influenza Viruses

Influenza, commonly referred to as "flu", is an infectious disease caused by RNA viruses of the family Orthomyxoviridae, A.K.A. influenza viruses. Three genera of the five Orthomyxoviridae can infect human beings. Influenza B infects only humans, influenza A is the most most virulent, while influenza C mainly affect children.

Influenza spreads around the world in seasonal epidemics, resulting in the deaths of between 250,000 and 500,000 people every year, up to millions in some pandemic years. Usually, influenza pandemics occurs when a new strain of the virus appear, and these new strains appear when an existing flu virus spreads to humans from other animal species, or when an existing human strain picks up new genes from a virus that infects only birds or animals.

Influenza A & B Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
FLU 831 Influenza A/B AG Test Strip Throat & Nasal Swab 100 Bulk: 1500 PCS
Boxed: 48 Boxes
FLU 8312 Influenza-A IGM Dot Assay serum/plasma 25 Bulk: 1200 PCS
Boxed: 36 Boxes
FLU 8322 Influenza-B IGM Dot Assay serum/plasma 25 Bulk: 1200 PCS
Boxed: 36 Boxes
FLU 8323 Influenza-B IGM Dot ELISA serum/plasma 48 Bulk: 42 PCS
Boxed: 42 Boxes
How to Use

Influenza A/B AG Test Strip

General Information

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

Catalog No.:FLU 831
Description:Influenza A/B AG Test Strip
Category:Respiratory Tract Disease
Style:Dipstick
No. of Step:One Step
Specimen:Throat & Nasal Swab
Quan. or Qual.:Qualitative
Reading Time:15-20 Minutes
Specification:5.0 mm
Sensitivity A: 95.3%
Specificity A: 99.1%
Sensitivity B: 94.7%
Specificity B: 98.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1500 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.5 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Test Strip for Influenza A&B Antigens;
  • Disposable sample tubes;
  • Assay diluents;
  • Disposable Droppers (to transfer 300ul of diluent );
  • Sterilized Swabs for Sample collection;
  • Package insert.

Specimen

Throat Swab

To collect a throat swab specimen, vigorously rub a rayon throat swab on both tonsillar surfaces and the posterior pharynx.

Remove swab from mouth and insert, tip down, into paper wrapper.

Nasal Swab Specimen

Use the sterile swab supplied in the kit. Insert this swab into the nostril that presents the most secretion under visual inspection.

With gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch in the nostril). Rotate the swab three times against the nasal wall.

Or, insert the swab into nostril parallel to the palate and leave in place for a few seconds to absorb specimens.

Throat & Nasal Swab Storage Condition

It is recommended that swab specimens be processed as soon as possible after collection.

If swabs are not processed immediately they should be placed into a dry, sterile, and tightly sealed plastic tube for storage. Swabs can be stored dry at room temperature for up to 24 hours.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody 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 antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody 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 protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Influenza-A IGM Dot Assay

General Information

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

Catalog No.:FLU 8312
Description:Influenza-A IGM Dot Assay
Category:Respiratory Tract Disease
Style:DOT Card
No. of Step:Two Step
Specimen:serum/plasma
Quan. or Qual.:Qualitative
Reading Time:3 Minutes
Specification:25T
Unit:PCS
Cut Off:
Sensitivity:
Specificity:
Method:DGFIA Double Antibody Sandwich

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

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 DGFIA Double Antibody Sandwich

DGFIA Double Antibody Sandwich Method Illustration

With this double antibody test, the detection target usually is hormone protein or viral antigen.

In this kind of dot filtration immunoassay test kit, monoclonal or polyclonal antibodies specific to the target protein or antigen are used as capturer, which are pre-coated in a dot area in the millipore filtering membrane, which called test region. And another antigen or secondary antibody, such as mouse anti-goat IgG antibodies, is coated in another dot area, which is supposed to develop visual red dot regardless of the testing results. This is the mechanism to insure that the procedure is correctly followed, and the reagent is not deteriorated.

When the sample is added, the antigen, if present, will react with the pre-coated antibody, and bounded there.

After washing the membrane with diluents, the antibody colloidal gold conjugate is added. The antibody will bind to another site on the antigen, which is captured in the previous step. When the antibody-antigen-antibody complex develops, the conjugated colloidal gold particles will congregate and develop red or pink color, indicating a positive result.

If there is no target antigen or viral protein in the sample, the complex will not develop, the colloidal gold particles will not gather, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Influenza-B IGM Dot Assay

General Information

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

Catalog No.:FLU 8322
Description:Influenza-B IGM Dot Assay
Category:Respiratory Tract Disease
Style:DOT Card
No. of Step:Two Step
Specimen:serum/plasma
Quan. or Qual.:Qualitative
Reading Time:3 Minutes
Specification:25T
Unit:PCS
Cut Off:
Sensitivity:
Specificity:
Method:DGFIA Double Antibody Sandwich

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

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 DGFIA Double Antibody Sandwich

DGFIA Double Antibody Sandwich Method Illustration

With this double antibody test, the detection target usually is hormone protein or viral antigen.

In this kind of dot filtration immunoassay test kit, monoclonal or polyclonal antibodies specific to the target protein or antigen are used as capturer, which are pre-coated in a dot area in the millipore filtering membrane, which called test region. And another antigen or secondary antibody, such as mouse anti-goat IgG antibodies, is coated in another dot area, which is supposed to develop visual red dot regardless of the testing results. This is the mechanism to insure that the procedure is correctly followed, and the reagent is not deteriorated.

When the sample is added, the antigen, if present, will react with the pre-coated antibody, and bounded there.

After washing the membrane with diluents, the antibody colloidal gold conjugate is added. The antibody will bind to another site on the antigen, which is captured in the previous step. When the antibody-antigen-antibody complex develops, the conjugated colloidal gold particles will congregate and develop red or pink color, indicating a positive result.

If there is no target antigen or viral protein in the sample, the complex will not develop, the colloidal gold particles will not gather, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Influenza-B IGM Dot ELISA

General Information

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

Catalog No.:FLU 8323
Description:Influenza-B IGM Dot ELISA
Category:Respiratory Tract Disease
Style:DOT ELISA
No. of Step:Two Step
Specimen:serum/plasma
Quan. or Qual.:Qualitative
Reading Time:10-2-2-3 Minutes
Specification:6T/30T
Unit:Box
Cut Off:
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

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 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