hCG One Step Pregnancy Test Device

Human chorionic gonadotropin (hCG) is a pregnancy-related hormone. It appears in blood and urine after pregnancy begins. Because hCG is strongly associated with pregnancy, it is the main hormone detected by urine and serum pregnancy tests. The hCG One Step Pregnancy Test Device helps detect the presence of hCG at or above the stated device cut-off. It does not measure the exact hCG level; it provides a qualitative result such as positive, negative, or invalid.

The hCG One Step Pregnancy Test Device (Serum/Urine) is intended for the qualitative detection of hCG in urine or serum samples. It is used as an aid for early pregnancy screening.

Applications

• Early pregnancy screening
• Fertility clinic testing
• Gynecology and women’s health diagnostics
• Hospital and laboratory pregnancy testing
• Pre-procedure pregnancy screening support
• International diagnostic product supply
• Point-of-care testing environments

The hCG One Step Pregnancy Test Device uses the colloidal gold immunochromatographic method. In this method, antibodies react with hCG in the sample. If hCG is present at or above the test cut-off, a visible test line appears in the result window.

Benefits

• Simple visual result format
• No complex instrument required
• Fast sample-to-result workflow
• Suitable for urine and serum testing
• Easy handling in clinical settings
• Built-in control line for procedural validation
• Practical for international distribution

The hCG One Step Pregnancy Test Device can be positioned for serum and urine sample testing when both sample types are validated in the product IFU. Urine testing is convenient and non-invasive, while serum testing may be useful in clinical or laboratory environments.

Guidance

• Use a clean and dry urine container
• First morning urine may be preferred for early testing
• Avoid excessive fluid intake before testing
• Use the required number of drops as per IFU
• Read results within the recommended time window
• Serum testing should be performed by trained professionals
• Handle all biological samples with standard safety precautions

Note

LARKSOIS Pharma should clearly mention whether the device is validated for serum only, urine only, or both serum and urine in the final IFU and product label.

The hCG One Step Pregnancy Test Device by LARKSOIS Pharma has a stated cut-off of 25 mIU/ml. This means the device is designed to show a positive result when hCG is detected at or above this level, according to the product’s validated performance. LARKSOIS Pharma should use only its validated performance data in the final IFU, label, and regulatory documents.

Steps

• Bring the test device and specimen to room temperature
• Open the sealed pouch only when ready to test
• Place the device on a clean, flat surface
• Add the required number of urine or serum drops into the sample well
• Wait for colored lines to appear
• Read the result within the approved reading time
• Do not interpret results after the stated time window

Note

The exact procedure for the hCG One Step Pregnancy Test Device should always follow the official LARKSOIS Pharma product insert.

Positive

A positive result usually shows both the control line (C) and test line (T). This indicates that hCG has been detected in the serum or urine sample at or above the device cut-off.

Negative

A negative result usually shows only the control line (C) and no test line. This means hCG is not detected or is below the cut-off level at the time of testing.

Invalid

If the control line does not appear, the result is invalid. The test should be repeated with a new device and fresh sample according to the product IFU.

Instructions

• Do not use expired test devices
• Do not reuse the device
• Do not use damaged or opened pouches
• Do not mix different specimens
• Handle serum specimens as potentially infectious material
• Dispose of used devices according to local regulations
• Confirm uncertain results with medical consultation or laboratory testing

Instructions

• Store in a dry place
• Keep away from direct sunlight
• Do not freeze
• Keep sealed until use
• Use before the expiry date
• Follow the temperature range printed on the package

Note

LARKSOIS Pharma should mention its own confirmed shelf life based on stability data.

LARKSOIS Pharma offers fertility and diagnostic products designed for international healthcare markets. The hCG One Step Pregnancy Test Device (Serum/Urine) is suitable for professional diagnostic buyers who need a practical, fast, and reliable pregnancy screening product.

Advantages

• Serum and urine sample compatibility
• Colloidal gold rapid test method
• 25 mIU/ml cut-off
• Easy visual result interpretation
• Fertility and pregnancy screening application
• Suitable for clinics, laboratories, and distributors
• International product positioning under LARKSOIS Pharma