Entamoeba histolytica serological reagents” are laboratory kits containing specific antigens and antibodies used to detect the presence of antibodies against Entamoeba histolytica in a patient’s blood serum, essentially serving as a diagnostic tool for identifying an infection caused by this parasitic amoeba, commonly known as amoebiasis; these reagents are typically used in immunoassay techniques like ELISA (Enzyme-Linked Immunosorbent Assay) to qualitatively determine the level of antibodies present in a sample

The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.

INTENDED USE: It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history.

DEVICE DESCRIPTION: The device contains a reaction window with two vertical lines of immobilized antibodies. The test line (“T”) contains monoclonal antibodies specific for E. histolytica adhesin. The control line (“C”) contains antibodies to horseradish peroxidase (HRP). The Conjugate consists of polyclonal antibodies to E. histolytica adhesin coupled to horseradish peroxidase. The “T” reaction is examined visually for the appearance of a vertical blue line on the “T” side of the Reaction Window. A blue line indicates a positive test. A positive “C” reaction, indicated by a vertical blue line on the “C” side of the reaction window, monitors/confirms that the sample and reagents were added correctly, the reagents were active at the time of performing the assay, and that the sample migrated properly through the membrane device. It also confirms the reactivity of the other reagents associated with the assay.

INTENDED USE: This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giardia gastrointestinal infections.  As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history.  For In-Vitro Diagnostic use.

DEVICE DESCRIPTION: Giardia test strip (5mm x 60mm) combines a nitrocellulose membrane with designated fiber pads (conjugate, sample and absorbent). The test strip is placed into a plastic housing and is sealed constituting the Test Device.  The test strip consists of A) Mouse anti-Giardia lamblia antibody coated onto the Test Line region, B) Rabbit anti-goat IgG antibody coated onto the Control Line region, C) Goat anti-Giardia lamblia antibodies and Goat IgG antibodies conjugated to red latex particles and dried onto the inert glass fiber conjugate pad which is positioned on the test strip below the nitrocellulose zone.  The housing contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes.

Intended Use: Toxoplasma IgG Positive Control is a human blood-based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Toxoplasma gondii. This control is not intended as a substitute for controls provided with test kits.

Device Description: Toxoplasma IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Toxoplasma gondii, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative.

This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Toxoplasma gondii in human serum and plasma.

INTENDED USE: This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections.  As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history.  For In Vitro Diagnostic use.

DEVICE DESCRIPTION: Cryptosporidium test strip (5mm x 60mm) combines a nitrocellulose membrane with designated fiber pads (conjugate, sample and absorbent). The test strip is placed into a plastic housing and is sealed constituting the Test Device.  The test strip consists of A) Mouse anti-Cryptosporidium parvum antibody coated onto the Test Line region, B) Goat anti-mouse IgG antibody coated onto the Control Line region, C) Mouse anti- Cryptosporidium parvum antibodies and mouse IgG antibodies conjugated to red latex particles and dried onto the inert glass fiber conjugate pad which is positioned on the test strip below the nitrocellulose zone.  The housing contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes.

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Assay cut-off.
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay
• Prozone effect study

The same is applicable for CE Marking under IVDR also.

Required for 510k submission and also IVDR CE Marking