Innovita Rapid Pregnancy Test 1 Piece

Innovita Rapid Pregnancy Test is an in vitro diagnostic home medical device designed for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. Utilizing a rapid lateral flow immunochromatographic assay, the test strip incorporates colloidal gold-conjugated monoclonal anti-$\beta$-hCG antibodies on the sample conjugate pad and immobilized polyclonal anti-$\alpha$-hCG antibodies along the test line (T). When urine is applied, capillary action drives the sample across the membrane. If hCG is present at or above the analytical sensitivity threshold of 25 mIU/ml, it forms a visible pink/purple antibody-antigen-antibody sandwich band at the test zone. An integrated procedural control line (C) confirms adequate liquid volume and membrane wicking, packaged as 1 single-test foil pouch with a desiccant.

Key Benefits

• High Analytical Sensitivity: Detects urinary hCG concentrations as low as 25 mIU/ml, allowing reliable testing from the very first day of a missed menstrual period.

• Rapid Clinical Results: Delivers unambiguous, easy-to-read visual chromatographic results within 3 to 5 minutes.

• High Diagnostic Accuracy: Demonstrates greater than 99% accuracy when performed in accordance with manufacturer instructions.

• Early Detection Capability: Sensitive to early gestational hormone rises following blastocyst implantation.

• Hygienic Single-Use Format: Hermetically sealed individual packaging ensures test membrane integrity and prevents external moisture degradation.

Key Components

• Active Reagents per Test: Colloidal gold-labeled mouse monoclonal anti-$\beta$-hCG antibodies, goat anti-mouse IgG polyclonal antibodies (control zone), and purified anti-$\alpha$-hCG capture antibodies (test zone).

• Test Strip / Cassette Housing: Nitrocellulose membrane matrix, sample absorbent pad, polyester conjugate pad, and protective casing.

Key Features

• Product Type: In Vitro Diagnostic (IVD) Rapid Lateral Flow Urine Test Device

• Indications: Early home screening and confirmation of clinical pregnancy

• Sensitivity: 25 mIU/ml hCG

• Accuracy: > 99%

• Reading time: 3 to 5 minutes (do not interpret results after 10 minutes)

• Pack size: 1 individually sealed test device (with desiccant)

How to Use

• Collect fresh urine in a clean, dry container (first-morning urine is strongly recommended for highest hCG concentration).

• Remove the test device from the foil pouch just before testing and place it on a flat, dry surface.

• Immerse the absorbent tip into the urine sample (or dispense urine into the sample well using the dropper) for the specified duration without exceeding the maximum mark.

• Wait for colored bands to appear and read the result between 3 and 5 minutes; do not read after 10 minutes:

  • Positive (Pregnant): Two distinct colored lines appear (one in the control zone "C" and one in the test zone "T").

  • Negative (Not Pregnant): Only one colored line appears in the control zone "C".

  • Invalid: No line appears in the control zone "C" (the test must be repeated with a new device).