Pregnancy Test Strip

Pregnancy Test Strip

$1.50

Description

SPECIMENS COLLECTION

  1. The urine specimens must be collected in a clean dry container either plastic or glass without preservatives. No centrifugation or filtration of urine is required. Specimens collected at any time may be used. However the first morning urine generally contains the highest concentration of the hormone.
  2. If specimens cannot be tested within 3 days of collection, they should be stored refrigerated at 2-8 degrees C.

Instructions:

  1. Remove the dipstick from pouch and label the device with specimen identification.
  2. Carefully place the white end of the hCG Smart Strip into the specimen vial. Make sure that the absorbent patch is submerged in the urine. 10 to 30 seconds into the sample is sufficient.
  3. Remove the test strip from the urine.  Read results within 10 minutes.  A pink-colored control line should appear at the top of the strip indicating a valid result.

INTERPRETATION OF RESULTS

Negative: Only one colored line appears on the control region. No line appears in the test region.
Positive: In addition to the control line, a distinct colored band also appears in the test region.
Invalid: If no bands appear, or a test band appear without a control band, the test should be repeated using a new dipstick.

 

LIMITATION

  1. The hCG Smart Strip (Urine) is a qualitative assay and is not intended for any use other than for the early detection of pregnancy.
  2. In addition to the normal elevations of hCG produced in pregnancy, a number of conditions including trophoblastic disease, proteinuria, hematuria, choriocarcinoma, ovarian and testicular teratomas cause elevated levels of hCG. These diagnoses should be taken into account when reading test results.
  3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

PERFORMANCE CHARACTERISTIC

Sensitivity:

The analytical sensitivity of hCG Smart Strip (Urine) has been set at 20 mIU/ml. A urine specimen contains hCG concentrations equal to or greater than 20mIU/ml hCG gives a positive result. The sensitivity was also evaluated by a panel of urine samples spiked with hCG to the concentrations of 0, 20, 50, 100, 500mIU/ml. The results are shown in Table 1.

 

HCG Concentration
(mIU/ml)

0

20

50

100

500

Sample number

20

20

20

20

20

Positive

0

20

20

20

20

Negative

20

0

0

0

0

Specificity:

Specificity was determined from cross reaction studies with known amounts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH) and Thyroid Stimulating Hormone (hTSH). 500mIU/ml hLH, 1000mIU/ml hFSH and 1000mIU/ml hTSH. All gave negative results.

Accuracy:

A study was performed using a total of 66 randomly selected urine specimens. These specimens were assayed with hCG Smart Strip (Urine) and a similar commercial available qualitative visual pregnancy test. The results indicated a complete agreement (36 positive specimens and 30 negative specimens).



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