Molecular Diagnostics

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Sexually Transmitted Diseases

DiAGSure Hepatitis B Viral Load Kit

Hepatitis B is a highly preventable liver diseases caused by the Hepatitis B Virus which affects the liver. It can cause acute and chronic infection. More than 350 million individuals 8.5% of the world population are chronic HBV carrier. The cause is the hepatitis B virus. Having chronic hepatitis B increases your risk of developing liver failure, liver cancer or cirrhosis — a condition that permanently scars of the liver. Other symptoms of this disease are fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay-colored bowel movements, and joint pain, jaundice (yellow color in the skin or the eyes). DiAGSure kits use endogenous IC to take care of sample quality along with process control. Per 25 uL reaction requires 10 uL of sample DNA input. In case of concentrated DNA, the DNA maybe diluted 1:2 or 1:10 (as per requirement with DNA dilution buffer in the kit) before template addition. We are providing additional reagents so that a customer can run the set of four quantitative standards per 10 samples.
  • Specimen type: whole blood, plasma or serum
  • Genotype Coverage: Detects all 8 HBV genotypes A-H
  • Technology: 2-plex TaqMan PCR (one for target, other for internal control)
  • Turn-around-time: 1 hr 10 mins
  • Sensitivity: 3 copies of in vitro cloned viral Core/precore gene construct equivalent to 2.68 IU/mL viral count.
  • Specificity: 100%

DiAGSure Hepatitis C Viral Load Kit

Hepatitis C is a liver infection that can lead to serious liver damage. It’s caused by the hepatitis C virus .it is the most common blood borne viral infection. The virus can caused both acute and chronic hepatitis. Others symptoms are: Bleeding easily, bruising easily, fatigue, poor appetite, yellow discoloration of the skin and eyes, dark coloured urine, itchy skin, weight loss, swelling on legs, spider angiomas, and hepatic encephalopathy. DiAGSure kits use endogenous IC to take care of sample quality along with process control. Per 20 uL reaction requires 10 uL of sample RNA input. In case of concentrated RNA, the RNA maybe diluted 1:2 or 1:10 (as per requirement with RNA dilution buffer in the kit) before template addition. We are providing additional reagents so that a customer can run the set of four quantitative standards per 10 samples.
  • Specimen type: whole blood, plasma or serum
  • Genotype Coverage: Detects all six genotypes (1-6) of HCV
  • Technology: 2-plex TaqMan PCR (one for target, other for internal control)
  • Turn-around-time: 1 hr 15 mins
  • Sensitivity: The sensitivity of the kit is less than 100 copies of viral RNA equivalent to 22.7 IU/mL viral count.
  • Specificity: >=99.99%

DiAGSure HIV-1 Detection Kit

HIV (human immunodeficiency virus) is a virus that attacks the body's immune system. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome). Learning the basics about HIV can keep us healthy and prevent HIV transmission. There are two major types of the human immunodeficiency virus. HIV-1, which was discovered first, is the most widespread type worldwide. HIV-2 is more than 55% genetically different from HIV-1.
  • Specimen type: whole blood, plasma or serum
  • Genotype Coverage: A-H, J,K and recombinants
  • Technology: 2-plex TaqMan PCR (one for target, other for internal control)
  • Turn-around-time: 1 hr 15 mins
  • Sensitivity: The sensitivity of the kit is less than 100 copies of viral RNA equivalent to 57.47 IU/mL viral count.
  • Specificity: >=99.99%

DiAGSure HPV-16/18 Detection Kit

A large majority of cervical cancer (more than 95%) is due to the human papillomavirus (HPV). HPV is the most common viral infection of the reproductive tract. Symptoms of HPV infections include genital warts, common warts, plantar warts and flat warts. HPV-16 and HPV-18 are responsible for more than 95% of cervical cancers. HPV high-risk serotypes are responsible for 60-70% of oral cancer and several cases of head & neck cancer. Genomic integration of HPV high-risk serotypes have been implicated in many types of cancer. Endogenous IC ensures proper sample type as well as process control. Multiplex PCR allows the detection of both serotypes (HPV-16/18) in a single-tube reaction. A 25 uL reaction requires 10 uL DNA input. Positive control (PC) is so provided in the kit such that a customer can run a PC along with 10 samples. On the contrary, a customer can half-dilute the PC to run a single PC per 5 samples.
  • Specimen type: cervical swab, oral swab in VTM, biopsy sample, FFPE sample, urine, menstrual blood
  • Technology: 3-plex TaqMan PCR (one for each target of HPV-16 & HPV-18, other for internal control)
  • Coverage: HPV-16 & HPV-18 high-risk serotypes
  • Turn-around-time: 1hr
  • Sensitivity: 3 copies of in vitro cloned E6 oncoprotein gene construct.
  • Specificity: 100%

DiAGSure Chlamydia trachomatis Detection Kit

Chlamydia trachomatis is a gram-negative bacterium that infects the columnar epithelium of the cervix, urethra, and rectum, as well as non-genital sites such as the lungs and eyes. Most persons with this infection are asymptomatic. Untreated infection can result in serious complications such as pelvic inflammatory disease, infertility, and ectopic pregnancy in women, and epididymitis and orchitis in men. Men and women can experience chlamydia-induced reactive arthritis.
  • Signs and symptoms of Chlamydia trachomatis infection can include: Painful urination, vaginal discharge in women, discharge from the penis in men, painful sexual intercourse in women, bleeding between periods and after sex in women, testicular pain in men.
  • Sample type: urine and genital swab samples.
  • Technology: 2-plex TaqMan PCR (one for target, other for internal control)
  • Minimum sample volume 1 mL
  • Turn-around-time: 1 hr
  • Test Sensitivity: 30 copies of in vitro cloned Chlamydia trachomatis ompA gene construct.
  • Specificity: >=99%

DiAGSure Panfungal Detection Kit

The prevalence of fungal infections has increased in recent years due to an increasing population of immune-compromised patients, intensive immunosuppressive chemotherapy, increasing awareness of fungal infections, and the widespread use of broad-spectrum antibiotics and central venous catheters. The panfungal PCR assay can detect multiple fungal genera and may be used as an adjunct to conventional methods for the detection of fungal infection or for describing the natural history of fungal infection. Further studies are needed to define the sensitivity and specificity of this assay for the diagnosis of fungal infection prior to the existence of other clinical or laboratory indications of invasive fungal infection.
  • Symptoms of panfungal included Skin changes including red and possibly cracking or peeling skin, itching, redness and soreness on and surrounding the vagina. A red rash with a circular shape and rise edges, redness in the groin, buttocks, or thighs, chafing, irritation, itching, or burning in the infected area, Invasive fungal infections (IFIs) affect a multitude of organs leading to meningitis, sinusitis, osteomyelitis and enteritis.
  • Species coverage : 95%.
  • Sample type: Bronchoalveolar lavage (BAL), tracheal aspiration, sputum, nasal/oral swab in VTM, tear, pleural fluid, paraffin embedded tissue samples (FFPE), skin or nail swab, biopsy, blood and serum samples .
  • Minimum sample volume: 1 mL
  • Technology: 2-plex TaqMan PCR (one for target, other for internal control)
  • Turn-around-time: 48 hrs
  • Test Sensitivity: 10 copies of in vitro cloned fungal 18S rDNA.
  • Specificity: 99%

DiAGSure Candidiasis Detection Kit

Candidiasis is a fungal infection caused by a yeast (a type of fungus) called Candida. Some species of Candida can cause infection in people; the most common is Candida albicans & Candida tropicalis. Candida normally lives on the skin and inside the body, in places such as the mouth, throat, gut, and vagina, without causing any problems. Candida can cause infections if it grows out of control or if it enters deep into the body (for example, the bloodstream or internal organs like the kidney, heart, or brain).
  • Detects the presence of Candida albicans and Candida tropicalis (key players of the disease) DNA in clinical samples. Meant for detection of skin, oral, vaginal and invasive candidiasis.
  • Symptoms vary depending on body location, but include the following: rashes, red or purple patches (area with an altered surface),white, flaky substance over affected areas, scaling, or shedding of the skin with flakes, cracks in the skin, soreness, erythema, which results in areas of redness, maceration, or the appearance of soft white skin, creamy satellite pustules at margins of affected areas (pimples filled with pus), red and white lesions in the mouth, as seen in oral thrush.
  • Specimen type: skin swab for skin candidiasis, genital swab for vaginitis, buccal swab for oral candidiasis, whole blood for invasive candidiasis
  • Species coverage: Candida albicans and Candida tropicalis
  • Minimum sample volume: 1 mL
  • Turn-around-time: 48 hrs
  • Sensitivity: 30 copies of in vitro cloned Candida albicans ITS2 and tropicalis ITS1 gene constructs respectively.
  • Technology: 2-plex TaqMan PCR (one for target, other for internal control)
  • Specificity: >=99%

DiAGSure HSV Detection and Genotyping Kits

The herpes simplex virus, also known as HSV, is an infection that causes herpes. Herpes can appear in various parts of the body, most commonly on the genitals or mouth. There are two types of the herpes simplex virus: HSV-1& HSV-2 Some of the symptoms associated with this virus include: blistering sores (in the mouth or on the genitals), pain during urination (genital herpes), itching, fever, swollen lymph nodes, headaches, tiredness, lack of appetite. HSV can also spread to the eyes, causing a condition called herpes keratitis. Endogenous IC enables proper sample quality check. Positive control (PC) is so provided that a customer can run a PC per 10 samples (or per 5 samples by half-dilution of PC).
  • Specimen type: Whole blood, Tear, vitreous biopsy, urine, genital swabs
  • Genotype Coverage: HSV Detection kit detects both HSV genotypes HSV-1 and HSV-2. HSV genotyping kit further discriminates between those two genotypes.
  • Technology: 2-plex TaqMan PCR (one for target, other for internal control)
  • Turn-around-time: 1hr
  • Sensitivity: 10 copies of HSV DNA
  • Specificity:=99%