Kits to Test Disease-Causing Bacteria

A new product line, called Identikit, is designed for the rapid identification and antibiotic testing of disease-causing pathogens.

The biophasic system comprises devices to cultivate and identify pathogenic microorganisms such as Mycobacterium tuberculosis, Mycobacterium avium complex (MAC), and Paratuberculosis, as well as Pseudomonas and Nocardia species. The basic test kit consists of a glass slide coated with paraffin, used as a carbon source by certain bacterial species. The slides are incubated in a sample of almost any body fluid (saliva is preferred) within a nutrient broth. This creates a semi-solid growth medium for the bacteria, which imitates their natural environment within a human or animal host.

The bacteria collect on the paraffin slide in four to eight days. Testing can then be done to identify the species of bacteria. This can be done via acid-fast staining or through polymerase chain reaction (PCR) gene amplification. The bacteria can also be cultured with antibodies to test for specific sensitivities. Through the choice of different nutrient broths, each kit can be tailored to encourage the growth of a specific bacterium. By using saliva or stool samples, the process could identify an infection as much as 10 months before the bacterium could be found in blood samples and well before symptoms begin, stated the company.

The Indentikit line of products was developed by Infectech, Inc. (Sharon, PA, USA). Because the devices are categorized as medical devices, the standard lengthy approval process of the U.S. Food and Drug Administration (FDA) was not required, only registration of the company and its product line.

MAC is the primary bacterial infection associated with "wasting syndrome” of HIV/AIDS patients and is a leading cause of death among these patients worldwide. MAC is often resistant to anti-tuberulosis drugs, and there has been no standardized method for determining antibiotic sensitivity. MAC is usually diagnosed in HIV/AIDS patients after symptoms appear, by a diagnostic screen that utilizes a blood test. By that time, mortality is very high and time to death is estimated at about five months. Infectech's Indentikit could detect MAC significantly sooner than expected for normal culture techniques, according to Paul Hyman, Ph.D., primary investigator in the company's ongoing validation studies.

"Dr. Hyman's validation of Infectech's patented technology and the subsequent FDA registration clearly show that we can identify a costly disease in a fraction of the time,” commented Dr. Mitchell Felder, CEO of Infectech. "These results may also have enormous implications in the treatment of TB, AIDS, and MAC sufferers, as an antibiotic-sensitivity test can now be performed early enough to make a difference in these patients.”




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