hCG One Step Pregnancy Test Strip

Human chorionic gonadotropin (hCG) is a hormone produced by the developing placenta shortly after fertilization. Because hCG rises during early pregnancy, it is widely used as a marker for pregnancy screening. The hCG One Step Pregnancy Test Strip detects hCG at or above the test’s validated detection level. A positive result suggests hCG is present, while a negative result means hCG is not detected or may be below the test sensitivity at the time of testing.

The hCG One Step Pregnancy Test Strip (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 pregnancy screening support
• Laboratory-based rapid testing
• Pre-procedure pregnancy screening support
• International diagnostic supply

The hCG One Step Pregnancy Test Strip uses the colloidal gold method, a widely used rapid immunochromatographic technology. In this method, hCG in the sample reacts with specific antibodies on the strip. If hCG is present at a detectable level, a visible test line appears along with the control line.

Benefits

• Fast visual result interpretation
• Simple strip-based workflow
• No advanced analyzer requirement
• Easy use in clinics and laboratories
• Compact product format
• Suitable for international distribution
• Reliable screening support when used correctly

The hCG One Step Pregnancy Test Strip may be used with urine and serum when both sample types are validated in the product instructions. Urine testing is simple, non-invasive, and commonly used for pregnancy screening. Serum testing should be performed by trained healthcare or laboratory professionals.

Guidance

• Use urine or serum only if validated in the product insert
• Collect urine in a clean and dry container
• First morning urine may improve early detection because it is more concentrated
• Serum samples should be handled by trained professionals
• Follow the LARKSOIS Pharma product insert carefully
• Read the result only within the approved time window
• Do not reuse the test strip

Note

For product labeling, LARKSOIS Pharma should clearly mention whether the strip is validated for serum only, urine only, or both serum and urine.

Similar hCG rapid test strip products commonly list a sensitivity of 25 mIU/mL and state that the test detects hCG at concentrations of 25 mIU/mL or greater. LARKSOIS Pharma should mention the exact cut-off only according to its own product validation and IFU.

Steps

• Bring the test strip and sample to room temperature
• Open the sealed pouch only when ready to test
• Collect urine or serum sample as instructed
• Dip the strip vertically into the specimen without crossing the maximum line
• Keep the strip immersed for the instructed time
• Place the strip on a clean, non-absorbent flat surface
• Read the result within the approved time window

Note

The exact procedure for the hCG One Step Pregnancy Test Strip by LARKSOIS Pharma should follow the official IFU supplied with the product.

Positive

A positive result usually shows both the control line (C) and the test line (T). This indicates that hCG has been detected in the sample at or above the test’s detection level.

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 sensitivity 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 strip and fresh sample.

The hCG One Step Pregnancy Test Strip is a screening aid, not a complete diagnostic conclusion. Very dilute urine may not contain representative hCG levels, and retesting with first morning urine after 48 hours may be recommended if pregnancy is still suspected.

Instructions

• Use only according to the official product insert
• Do not use expired or damaged strips
• Do not reuse the strip
• Do not interpret results after the approved time window
• False negative results may occur if testing is done too early
• False positive results are rare but may occur in some conditions
• A confirmed pregnancy diagnosis should be made by a healthcare professional after evaluating clinical and laboratory findings

Instructions

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

Instructions

• For in vitro diagnostic screening support only
• Use serum or urine only as validated by the product insert
• Do not use as the only basis for final clinical decision-making
• Do not use damaged, opened, or expired test strips
• Read results only within the approved time window
• Retest if pregnancy is suspected but the result is negative
• Consult a healthcare professional for confirmation and follow-up

LARKSOIS Pharma focuses on fertility and diagnostic products for international healthcare markets. The hCG One Step Pregnancy Test Strip (Serum/Urine) is designed for simple handling, rapid screening, and professional use.

Advantages

• Serum/urine pregnancy screening support
• Colloidal gold rapid test method
• Simple strip-based format
• Qualitative hCG detection
• Fast visual result interpretation
• Suitable for clinics, hospitals, laboratories, and distributors
• International product positioning under LARKSOIS Pharma