Why CheckMate?

•  Fast – Results in one to five minutes
•  Easy – Urine sample dip strip
•  Sensitive – Will detect HCG in urine wth concentrations greater than 25 mIU/mls
•  Accurate – Positive correlation of more than 99% was found testing random urine samples*
•  Convenient – Test at point-of-care

*Compared to a commercially available HCG IRMA (Serono MAIA) kit

Test Procedure

If urine specimen, or the dip-strips have been stored in the refrigerator, allow them to warm to room temperature before testing.

Use a new Check-Mate dipstrip for each sample.

Remove the dipstrip from the pouch. Label the back of the Check-Mate dipstrip with the patient’s name or control identification.
NOTE: Only touch the strip on the end with the solid blue tape. Contact with other parts of the strip may affect the performance of the test.

Step 1
Remove the dipstrip from the pouch. Label the back of the Check-Mate dipstrip with the patient’s name or control identification.
NOTE: Only touch the strip on the end with the solid blue tape. Contact with other parts of the strip may affect the performance of the test.

Step 2
Dip strip into the sample of urine up to the blue line indicated by the arrows for 5 seconds.

Step 3
This top pink line (below) is also the ‘Test Complete’ line and indicates that the test has been performed correctly. If the dipstrip remains blank then the test has been performed incorrectly and a fresh test started. Results will appear after 1-5 minutes.

Interpreting the results

POSITIVE
A line of any intensity below the ‘control’ line shows a positive result.

NEGATIVE
If nothing shows below the ‘control’ line, the test is negative.

Do not read the test after 15 minutes.

Specification

Sensitivity
CHECK-MATE urine dip-strips will detect HCG in urine with concentrations greater than 25 mIU/ml. The test has been standardized to World Health Organisation 1st IRP / 3rd IS 75 / 537.

Materials Provided
Test devices (test strips) sealed in an aluminium pouch with desiccant. Each dip-strip is used to perform one test only.

Accuracy
Positive correlation of more than 99% was found testing random urine samples, as compared to a commercially available HCG IRMA (Serono MAIA) kit.

Expected Values
HCG is not normally detected in the urine of healthy men and healthy non-pregnant women. The sensitivity of CHECK-MATE HCG Urine is 25 mIU/ml (WHO, 1st IRP). In normal pregnancy, HCG levels in urine can reach 25 mIU/ml (1st IRP) as early as 10 days post-conception, approximately 3 days before the expected period. CHECK-MATE dip-strips can therefore be used to determine pregnancy as early as the first day of the missed period. HCG levels continue to increase exponentially to reach a maximum concentration in excess of 200,000 mIU/ml at the end of the first trimester.

Cross Reactivity
HCG-free urine samples containing 500 mIU/ml of the glycoprotein LH & 1,000 mIU/ml of the glycoproteins FSH & TSH gave negative results.

Precautions

•  For in-vitro diagnostic use
•  Do not use the reaction units after the expiry date
•  All patient samples should be handled as if they were capable of transmitting disease.

Quality Control
A built-in control is included in the test. In addition, in accordance with good laboratory practice, negative and positive controls should be used with each assay. Such controls are available commercially.

Specimen Collection
For optimal results it is best to test the first urine voided in the morning because it contains the greatest concentration of HCG. However, specimen urine collected anytime during the day can be used. Specimens can be stored at 2 o C to 8 o C for up to 48 hours, or below -20 o C for at least 3 months. Specimens should not be frozen and thawed repeatedly. Thawed specimens should be inverted several times just prior to testing. Urine samples containing excessive bacterial contamination should not be used.

Limitations
As in the case of any other diagnostic procedures, the results obtained from this kit must be used only as an adjunct to other information available to the physician. A normal pregnancy cannot be distinguished from an ectopic pregnancy based on HCG levels alone. Positive results from very early pregnancy may later prove negative due to natural termination of pregnancy. This is estimated to occur in 50% of all conceptions. It is recommended that weak positive results be re-tested with a fresh urine sample 48 hours later. Patients with trophoblastic and non-trophoblastic disease, or specimens with a high Rheumatoid Factor ( RF ), may have elevated HCG levels, therefore the possibility of HCG secreting neoplasms should be eliminated prior to the diagnosis of pregnancy.

A negative result obtained with a urine specimen collected from a very early pregnancy may be due to an extremely low concentration of HCG. If pregnancy is still suspected, a test should be repeated on a fresh specimen obtained about 2 days later. If a urine specimen is too dilute (i.e., low specific gravity), it may not contain a representative urinary HCG concentration. If a negative result is obtained with a low specific gravity specimen and pregnancy is still suspected, a first morning specimen should be obtained and re-tested. After an extended period of time, negative results obtained with the recommended timing may become weakly positive. This may be due to a level of HCG less than 25 mlU/ml. If pregnancy is still suspected, a repeat test is suggested in after 48 hours.

In rare cases one pink line may appear 1 cm from the edge of the solid blue tape indicating a positive result with a very high concentration of HCG.

FAQs

BHR are here to help, and we welcome any feedback on any of our products. Should you have any questions regarding this, or any other product, please get in touch with us by email here and we’ll get right back to you and post all relevant questions on this page.