THPB-625 Hb Hp Rapid Diagnostic Test Kits Accurate High Sensitivity

A rapid, one step test for the qualitative detection of Hemoglobin and Haptoglobin-Hemoglobin complex in feces CE certified

Applications:

The Hb + Hb/Hp Combo Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of hemoglobin and/or haptoglobin-hemoglobin complex in feces.

Description:

The Hb + Hb/Hp Combo Rapid Test is a sandwich immunoassay. It is a combo test consisting of 2 individual tests, a hemoglobin (Hb) test and a hemoglobin-haptoglobin (Hb/Hp) complex test to selectively identify human Hb and/or Hb/Hp complexes in test samples. Each test contains a nitrocellulose membrane strip with an immobilized mouse anti- Hb -antibody on the test zone (T).

The Hb test has a pad containing poly anti-Hb colloidal gold and mouse IgE colloidal gold. The Hb/Hp complex test has a pad containing poly anti-Hp colloidal gold and mouse IgE colloidal gold. A goat-anti-mouse antibody is immobilized in the control line zone (C) on the nitrocellulose membrane. 90 to 120μl specimen (buffer mixed) specimen (containing the respective analytes, Hb and Hb/Hp complexes) is added onto the respective specimen pad.

The analytes (i.e. Hb and/or Hb/Hp complex) in the collected specimen couple with the mouse anti-Hb-antibody or anti-Hp-antibody of the gold conjugate pad thus forming antibody – antigen – colloidal gold complexes. While the liquid is moving along the membrane it transports these complexes by capillary action. When the antibody – antigen – colloidal gold complexes are transported across the membrane and reach the respective immobilized mouse anti- Hb-antibody on the membrane, they are trapped and will form a sandwich complex consisting of: immobilized antibody – antigen – antibody – colloidal gold for Hb and/ or Hb/Hp complex respectively.

Only when the applied specimen sample contains a certain concentration of Hb or Hb/Hp complex, the formation of this sandwich complex will result in a visible magenta color band in the respective test zones (T) of the membrane.

The colored C-line will always appear if the test has been performed correctly. The test sensitivity for Hb is 50ng/ml and Hb/Hp is 50ng/ml.

How to use?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1.To collect fecal specimens:

Collect feces in a clean, dry specimen collection container. Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours.

2.To process fecal specimens:

Unscrew the cap of the specimen collection tube,then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites. Do not scoop the fecal specimen.

Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.

3.Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.

4.Hold the specimen collection tube upright and open the cap onto the specimen collection tube.

Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately

120μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in

the specimen well (S). See illustration below.

5.Read results at 5 minutes. Do not read results after 10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of hemoglobin or haptoglobin-hemoglobin complex present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure.

Order Information

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.