Frequently Asked Questions - Point of Care Tests

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Frequently Asked Questions - Point of Care Tests

OSOM^®

Q. How is the OSOM^® Ultra Strep A test different than other rapid diagnostics on the market?

A. Studies comparing the performance of Ultra Strep A and standard single swab culture method showed that there is no statistical difference between the two methods (see package insert for study details). In addition, Ultra Strep A was tested against a rigorous Gold Standard (dual swab + pledget) resulting in 92.6% sensitivity (see package insert for study details) .

Q. What is the difference between sensitivity and specificity?

A. The best way to explain sensitivity and specificity is by using an example.

For instance, if the test is 96% sensitive, that means it will detect Strep A antigen 96% of the time when Strep A antigen is present in the sample.

Specificity tells how accurate the test is at picking up that specific antigen. For instance, if a test has 96% specificity, that means it will pick up Strep A antigen correctly 96% of the time when Strep A antigen is present in the sample vs. picking up another antigen.

The method of comparison varies by product type. They are typically compared to whatever the "gold standard" is for that specific analyte.

Q. What is the difference between OSOM^® Strep A Test and OSOM^® Ultra Strep A Test?

A. The Ultra Strep A Test is the next generation in Strep A testing. It offers superior performance and sensitivity by utilizing a patented process known as Dual Label Technology™ (DLT)*. DLT uses antibody labeled color particles coated at two separate locations in the test device. DLT allows greater sensitivity than the conventional single label technology without sacrificing specificity, increasing background or causing false positives.

* U.S. Patent No. 6, 194, 221 B1

Pregnancy

Q. How many different pregnancy tests do you have?

A. The hCG product line for pregnancy tests includes:

Name

Description

CAT#

OSOM^® hCG Urine

Urine Dipstick test - 50 Test

#101

OSOM^® Card Pregnancy

Cassette test - 25 Test

#102

OSOM^® hCG Combo Test

Cassette Test - 25 tests

#124

Q. What are the differences and specifications?

A. The main differences are price and convenience.

The #101 is our most economical test. One step. Dip and read.

The #102 offers ease of use. Add 3 drops of urine. Read result.

The #124 (Combo Test) offers flexibility by allowing you to test urine or serum.

Additional features:
24 months dating

Q. How soon after conception can your test detect a positive?

A. In a normal pregnancy, hCG levels in urine can reach 25mIU/mL as early as 7-10 days post conception.

Mono

Q. Does the OSOM^® Mono test detect IgM or IgG antibodies?

A. The OSOM^® Mono test is for the detection of Infectious Mononucleosis heterophile antibodies which are primarily of the IgM class.

Q. How long can you keep the patient sample at room temperature before testing?

A. You must use the samples collected from a finger stick immediately. Whole blood samples collected by any other acceptable medical technique should be tested within 24 hours. Serum or plasma samples should be tested within 48 hours.

Q. What type of blood collection tube should be used for collecting the sample?

A. You can use tubes containing EDTA or Heparin.

Q. Do you have to use whole blood collected in a capillary tube?

A. You can use capillary tubes or any whole blood specimen collected by an acceptable medical technique, using a tube containing EDTA or heparin as an anticoagulant.