1. What is the stability of a patient sample once it has been applied to the test card?
2. If a fecal or gastric sample has been collected in a container, what is the pre-application sample stability?
3. Can I use expired HemaPrompt FG test cards?
4. Do HemaPrompt and HemaPrompt FG test cards have an internal negative control?
5. Do the Internal Performance Controls need to give acceptable results with each patient test in order for the result to be valid?
6. Why is it that when comparing positive gastric occult results on HemaPrompt FG and popular competitor's brand, it might take longer for the blue color to appear on the HemaPrompt FG Card?
7. How is it possible to test low pH gastric samples on HemaPrompt FG test cards without compromising results?
8. What is the sensitivity of HemaPrompt FG?
9. What is the normal amount of hemoglobin found in stools of healthy adults?
10. How should HemaPrompt Quality Control (QC) be documented?
11. How much does the HemaPrompt FG cost?
12. What is the difference between HemaPrompt FG and any competitor's brand?
13. I read/heard that it is a good idea to rehydrate sampled HemaPrompt sensitivity, is this correct?
14. Do I need to wait 2-5 minutes after sample application before developing a HemaPrompt FG test?
15. What CPT code should I use?
16. What is the reimbursement?
17. Can I get a Materials Safety Data Sheet (MSDS)?
18. Can I get a Package Insert?
19. Do external positive and negative controls need to be run with each new kit used?
20. Does the appearance of the blue checkmark (positive control), indicate a positive patient test result?
21. Does Aerscher sell external blood controls?
22. Is HemaPrompt suitable for outpatient home collection use?



Answers

1. What is the stability of a patient sample once it has been applied to the test card?
Answer: Fecal Sample: 5 days from date of application when stored properly at room temperature 15 - 30°C . Gastric Sample: 24 hours from date of application when stored properly at room temperature 15 - 30°C. All inoculated slides should be stored away from heat, light and volatile chemicals.

2. If a fecal or gastric sample has been collected in a container, what is the pre-application sample stability?
Answer: Fecal Sample: Blood in bulk stool is unstable. Once the fecal sample is collected, the sample should be applied to the test card immediately. Gastric Sample: 10 days at 5°C .

3. Can I use expired HemaPrompt FG test cards?
Answer:NO
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4. Do HemaPrompt and HemaPrompt FG test cards have an internal negative control?
Answer: YES. The background area surrounding the Positive Control functions as a negative control. The background color should remain white (unchanged) after developer is added.

5. Do the Internal Performance Controls need to give acceptable results with each patient test in order for the result to be valid?
Answer: YES. The Internal Controls should give the following acceptable results after the developer has been applied to the test card: Positive control should appear as a blue checkmark at the far right side of the card Negative control is the background area behind the blue checkmark: the color should remain white (unchanged).

6. Why is it that when comparing positive gastric occult results on HemaPrompt FG and popular competitor's brand, it might take longer for the blue color to appear on the HemaPrompt FG Card?
Answer: The guaiac paper used in HemaPrompt FG cards is coated on two sides, whereas the competitor's product is coated on one side, which allows for more rapid absorption. The end result is the same for both test methods.
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7. How is it possible to test low pH gastric samples on HemaPrompt FG test cards without compromising results?
Answer: A buffer is incorporated into the guaiac paper that adjusts the pH of the gastric sample, so quality results are obtained.

8. What is the sensitivity of HemaPrompt FG?
Answer: HemaPrompt FG has a sensitivity of 2mg of hemoglobin/gram of stool or 100 ug hemoglobin/ml of gastric sample.

9. What is the normal amount of hemoglobin found in stools of healthy adults?
Answer: 1 mg hemoglobin/gram of stool is considered a normal amount for healthy adults.
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10. How should HemaPrompt Quality Control (QC) be documented?
Answer: Follow your own laboratory or regulatory agency's guidelines.

11. How much does the HemaPrompt FG cost?
Answer: The Sales and Marketing department can quote you a price.

12. What is the difference between HemaPrompt FG and any competitor's brand?
Answer: The methodology is the same for both products; however, HemaPrompt FG is suitable for testing on fecal and gastric specimens. HemaPrompt also has a built-in developer with each test card.
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13. I read/heard that it is a good idea to rehydrate sampled HemaPrompt sensitivity, is this correct?
Answer: We do not recommend rehydrating sampled HemaPrompt. Rehydrating may increase sensitivity, however, you will also decrease specificity.

14. Do I need to wait 2-5 minutes after sample application before developing a HemaPrompt FG test?
Answer: NO - there is no wait time required after applying the specimen to the test card.

15. What CPT code should I use?
Answer: 82270 for all fecal occult blood testing and 82273 for occult blood testing on all other sources.
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16. What is the reimbursement?
Answer: National cap is $4.54 (as of 2003) for either CPT code (G0107 or 82270) submitted (Medicare).

17. Can I get a Materials Safety Data Sheet (MSDS)?
Answer: YES. A downloadable version of this document is located under the "Downloads" link.

18. Can I get a Package Insert?
Answer: YES. The package insert is available under the "Download' section of the website.
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19. Do external positive and negative controls need to be run with each new kit used?
Answer: NO - the on-board analyte control is Heme, which has been impregnated into the test card control area (Performance Control). Heme is the analyte in blood, which is being detected by this test. Since this analyte control is developed with each test performed, it is unnecessary to run external controls for each test. Aerscher Diagnostics recommends that external positive and negative controls be tested with each new shipment/ kit lot number that is received by the customer.

20. Does the appearance of the blue checkmark (positive control), indicate a positive patient test result?
Answer: NO - the appearance of the blue checkmark, the internal positive control, is used in conjunction with the internal negative control to indicate that the test was performed and is functioning correctly.

21. Does Aerscher sell external blood controls?
Answer: NO - we can recommend a manufacturer that sells external controls that are compatible with our product.
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22. Is HemaPrompt suitable for outpatient home collection use?
Answer: NO - HemaPrompt is not recommended for outpatient use. Current U.S. Postal Regulations prohibit mailing completed test slides in standard envelopes. Hemaprompt FG should not be sent in the mail and Aerscher does not provide postal approved mailing envelopes. Sending the card by mail may squeeze the developer out of the card when put through postal rollers used for mail sorting, making the card unusable. There is also the possibility that patients may develop their own test cards and not inform the physician of the occult blood result.
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For technical assistance, contact Sales & Marketing at (866) 425-7468 or e-mail nsmith@hemaprompt.com