hCG Combo Rapid Test CE

hCG Combo Rapid Test CE

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment.

The OnSite hCG Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human serum, plasma or urine.

The hCG detection limit of the OnSite hCG Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

  • Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
    • 100% sensitivity and 100% specificity in urine specimens
    • 100% sensitivity and 99.1% specificity in serum specimens
  • Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
  • Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
  • Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
  • Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
  • Shelf life: 24 month
  • Individually sealed foil pouches containing:

                   a. One cassette device

                   b. One plastic dropper

                   c. One desiccant

  • One package insert (instruction for use)

 

 

Catalog #

Product

Quantity

Specimen

R1001C

hCG Combo Rapid Test CE 

30/kit 

S/Urine

Other Products You Might Be Interested In..

Catalog #

Product

Quantity

Specimen

R1000S

hCG Urine Rapid Test (strip) CE

30/kit

Urine

R1001S

hCG Combo Rapid Test (Strip) CE

50/kit, 100/kit

S/Urine

To learn about distribution opportunities or for additional product information, please contact <http://www.privatedaddy.com?q=TmxadGRASE5QKTxpaldlaD5TcGpza3c-3D_19>

Product Features
  • Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is
    • 100% sensitivity and 100% specificity in urine specimens
    • 100% sensitivity and 99.1% specificity in serum specimens
  • Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
  • Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
  • Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
  • Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
  • Shelf life: 24 month
Kit Components
  • Individually sealed foil pouches containing:

                   a. One cassette device

                   b. One plastic dropper

                   c. One desiccant

  • One package insert (instruction for use)

 

 

Support
Order Information

Catalog #

Product

Quantity

Specimen

R1001C

hCG Combo Rapid Test CE 

30/kit 

S/Urine

Other Products You Might Be Interested In..

Catalog #

Product

Quantity

Specimen

R1000S

hCG Urine Rapid Test (strip) CE

30/kit

Urine

R1001S

hCG Combo Rapid Test (Strip) CE

50/kit, 100/kit

S/Urine

To learn about distribution opportunities or for additional product information, please contact <http://www.privatedaddy.com?q=TmxadGRASE5QKTxpaldlaD5TcGpza3c-3D_19>

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