- Condition: Factory New
- Warranty: Not Available
- Weight: 1.0 lb
- Designed to detect hCG in serum or urine
- CLIA waived for urine
- Serum and urine 25 mIU/mL sensitivity
- Physician’s licensing required. This is NOT an at-home test and should only be completed in a lab facility
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Learn more:
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Purchasing Restriction: Medical license or prescription required
- MFR: LifeSign Ships from Manufacturer
- MPN: 35035
- Phone: (800) 526-2125
Frequently asked questions
Does this test detect hCG in both serum and urine?
Yes, the LifeSign Status hCG Combo Cassette is specifically designed for dual-sample capability, allowing for the qualitative detection of human chronic gonadotropin (hCG) in both serum and urine specimens.
Key features of this dual detection capability include:
- Sample Flexibility: Use the same cassette format for either serum or urine, simplifying procedures.
- High Sensitivity: The test maintains a high sensitivity of 25 mIU/mL for both sample types, ensuring accurate results.
- Rapid Results: Definitive results are typically available within three to five minutes.
How quickly does this test provide results?
This rapid immunoassay delivers clear and definitive results very quickly, typically within three to five minutes. This fast turnaround supports timely clinical decision-making in a laboratory setting.
Is this test CLIA waived?
Yes, the LifeSign Status hCG Urine/Serum Combo Cassette is CLIA waived, but this status applies specifically to the urine testing component.
This means the procedure for detecting hCG in urine samples is simplified for regulatory compliance in certain laboratory environments. Please note that this product is intended for professional lab facility use only and is not an at-home test.
How many tests are in each box?
Each box of the LifeSign Status hCG Urine/Serum Combo Cassette contains 35 individual test cassettes. This quantity is suitable for clinical laboratories and medical facilities requiring a reliable supply for routine qualitative screening.
Does this test resist the Hook effect?
Yes, the LifeSign Status hCG Combo Cassette is specifically designed to minimize issues related to the Hook effect.The assay exhibits minimal susceptibility to interference caused by the hCG $\beta$ core fragment. This feature helps reduce the risk of false negatives, ensuring clearer and more definitive results for accurate qualitative detection of human chronic gonadotropin (hCG).
Is this test suitable for at-home use?
No, this LifeSign Status hCG Combo Cassette is not intended for at-home use.
It is a professional-grade rapid immunoassay tool designed exclusively for use in laboratory facilities by licensed professionals.
What is the high sensitivity of this hCG test?
The LifeSign Status hCG Urine/Serum Combo Cassette offers a high level of sensitivity for detecting hCG. The sensitivity is 25 mIU/mL, and this applies consistently to both serum and urine samples.
Is the testing procedure simple?
Yes, this cassette is designed for efficient and straightforward use in professional laboratory settings.
- The test utilizes a simple one-step procedure for qualitative detection of hCG.
- It provides rapid, definitive results typically within three to five minutes.
- Furthermore, the urine testing component is CLIA waived, which helps simplify regulatory compliance.
Is this test for professional use only?
Yes, the LifeSign Status hCG Urine/Serum Combo Cassette is designed exclusively for professional use in controlled environments. This product is:
- Intended only for lab facility use (it is not an at-home test).
- A professional-grade diagnostic tool that requires appropriate physician licensing for administration and interpretation.
Does this test simplify urine testing?
Yes, this test simplifies regulatory compliance for hCG detection in urine samples.
This is because the urine testing component of the LifeSign Status hCG Combo Cassette is CLIA waived (Clinical Laboratory Improvement Amendments).
This status allows the test to be performed in a wider variety of clinical settings with less complex regulatory oversight.