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Brandnew article about Calypte's oral test
(Dedicated to Sower for running this board):
These are essentials of the publication from Toby Gottfried and Ronald Mink published in a journal called Expert. Rev. Mol. Diagn, 139-144 (2006). (www. future drugs.com). The article is not freely accessible online.
This publication relates to the results of the Chinese trials (year 2005) which were used for the filing to the sFDA. The article also describes the results from trials done in Thailand. The results are excellent as it was published by the company some time ago so I don't repeat it here again. Nevertheless, the following additional aspects have been especially interesting to me:
1506 persons have been tested in this trial. 109 of them have been infected with Hepatitis C virus, 60 persons have had other diseases. 37 persons who were known HIV positive and receiving antiretroviral therapy were also tested.
First of all Calypte's oral test has thoroughly tested in terms of cross-reactivity with Hepatitis. From the 109 Hepatitis positive persons tested, all 109 have been identified correctly as HIV negative. There was no false positive with the rapid OMT test of Calypte. I personally find this remarkable because it seems that Oraquick, the only other commercial oral HIV test marketed by OSUR, seems to produce some false positives with Hepatitis-infected persons.
Calypte's test also worked equally well with persons on antiretroviral treatment. I would not have completely excluded that the testing of such patients is more difficult because they might have lower virus levels and thus lower antibody titer. Just my uneducated speculation (which could be naive) but in any case the test worked very well with these patients too.
Additional remarks apart from the trial results which I found remarkable:
1) A long-disputed topic: The price of Calypte's oral test. The article clearly states that the price of the oral test is competitive. The following two statements are cited from the publication:
"The cost per test for rapid tests [relates to all blood rapid test on the market] is slightly higher than ELISAs falling in the US$ 0.24-1.27 price range". [...]
"The Calypte AWARE HIV-1/2 OMT is an economical test, selling well within the cost range of rapid tests above."
2) "The ability to test for HIV without the need for a blood sample has been demonstrated to significantly increase voluntary testing rates."
Interesting to me because this is frequently mentioned but I don't have a lot of info that indeed prove this. The article refers to another publication which gives good data. It is a study done in Uganda with the former Calypte urine EIA (now Maxim). One result was that 14.3% more subjects provided urine than blood. There is another remark from a survey of 180 women in a New York family planning clinic: 21 % of those women declined HIV testing cited reluctance to have a blood draw as a reason for their refusal.
The reference is Sex. Transm. Dis, vol 26 (10) 1999, p. 590-592
3) "In sub-Saharan Africa only 75% of the blood is screened for HIV antibodies due to cost". Simply amazing to me. This published in the journal called Transfusion, vol. 45, Feb. 2005 page 133ff (no free access):
4) "There is an unknown window period for development of oral fluid HIV antibodies."
It is known that it takes months after the infection with HIV until the antibody appears in the blood stream of the infected person. That is the reason why the typical HIV blood test can detect infection only months after the infection has actually occurred. The article states that nobody knows if the antibody appears in oral fluid earlier, later or at about the same time than in the blood stream. Nevertheless, the trials with the oral test revealed that this is no problem as all infections detected from blood by the reference tests have been also detected with Calypte's oral test.
5) "The recent successful performance of AWARE HIV-1/2 OMT with oral fluid specimens, which cover the broad range of HIV subtypes in the develping world along with the inexpensive dipstick format, make it an attractive alternative to fingerstick whole blood." (cited from the publication)
I like to add for comparison the following sentence from an another reference which features the oral test of OSUR (Oraquick).
The reference is Expert. Rev. Mol. Diagn. 4(5), 587-591 (2004), (no free access online access):
"Despite the simplicity of the OraQuick ADVANCE Rapid HIV-1/2 test, the cost is relatively high, presenting a challenge to its widespread use in resource-limited settings." No further comments except that this might illustrate why OSUR is quite active in marketing the test in USA, and also focuses its additional efforts on markets like Europe, Singapur, Korea but not on developing world markets and also not China.
6) My personal highlight of this article:
"The adaptation of a successful rapid test platform to sample types other than blood and infectious diseases, such as tuberculosis and malaria, is the future trend in point-of-care testing. Although urine as a specimen in HIV testing is now FDA approved as the Maxim HIV-1 urine EIA and Urine HIV-1 Western Blot (previously Calypte Biomedical products), the development of a highly sensitive urine HIV-1/2 Rapid test is proving to be challenging. Among the many advantages for urine as a test sample are greater sample stability (even at high temeratures) than any other sample and abroader test menu range for HIV-related conditions, such as pregnancy, sexually transmitted diseases, abuse of drugs and general urinalysis."
and
"Curbing the transmission of tuberculosis and malaria in Africa is now receiving the attention of international funding organizations"
I always wondered why the company seems to prefer the urine over the oral test. At first sight it seems easier to draw an oral sample than an urine sample, isn' it? Now this is probably the reason. With urine, a full menu of diseases can be monitored after drawing only one sample. Great, an integrated rapid test platform for all relevant diseases. I remember from one of sower's transcripts wherein Dr George once said that there are even bigger markets than HIV detection Calypte is targeting in the long run. This is probably one the long term strategies we heard before when Dr George resigned. My speculation here.
Painfully establishing all these distribution and sales channels in the third world could even pay off bigger in the future when the company could one day market such an integrated rapid test platform. Now lets only hope they reach profitibility in 2006 and go on with these plans.
Hope the company keeps the fire burning.
Good luck.
Cal |
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