Products

The SARAGENE^® Mycobacterium Tuberculosis test is a Real-time PCR (RT-PCR) test that detects the presence or absence of IS6110 and MPB64 genes from tuberculosis complex members that includes Mycobacterium species M. tuberculosis, M. bovis, M. affricanum, M. canetti, M. microti, and M. pinnipedii from extracted nucleic acid samples. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Sample Types used for MTB Testing :

Pulmonary (Respiratory) and Extra-pulmonary (Non-Respiratory) samples.

Thermal Cycler Compatibility :

FAM^® (Green), Cal Fluor® Orange 560 (Yellow Channel), Cal Fluor® Red 610 (Orange Channel).

IVD Approved

The SARAGENE^® Malaria (IVD) Real-Time PCR Test detects the presence or absence of COX3 gene found in Plasmodium species: P. falciparum, P. vivax, P. ovale, P. malariae, and P. knowlesi. The test is optimized for use on deoxyribonucleic acid (DNA) extracted from whole blood samples. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Thermal Cycler Compatibility :

FAM^® (Green), Cal Fluor® Red 610 (Orange Channel)

IVD Approved

The SARAGENE^® Human papillomavirus (HPV) 16/18 (IVD) Real-Time PCR test is used for detection and differentiation of HPV genotypes 16 and/or 18. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Sample Types used for HPV 16/18 :

Cervical samples, genital swabs, tissues, FFPE blocks, and plasma or serum samples.

Thermal Cycler Compatibility :

FAM^® (Green), Cal Fluor® Orange 560 (Yellow Channel), Cal Fluor® Red 610 (Orange Channel).

IVD Approved

The SARAGENE^® Hepatitis B Virus (HBV) (IVD) Real-Time PCR test is used to detect the HBV genotypes A-H from Blood plasma/serum samples. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Thermal Cycler Compatibility :

FAM^® (Green), Cal Fluor® Red 610 (Orange Channel)

IVD Approved

The SARAGENE^® Hepatitis C Virus (HCV) Real-Time PCR (RT-PCR) test is used to detect the HCV genotypes 1-6 from Blood plasma/serum samples. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Thermal Cycler Compatibility :

Quasar® 670 (Red Channel), Cal Fluor® Red 610 (Orange Channel)

Validated against WHO International Standard for Hepatitis C

IVD Approved

The SARAGENE^® Chikungunya test kit is an in vitro diagnostic test, based on RT-PCR technology. The test is designed to detect the Chikungunya virus (IVD) using RNA extracted from patient's blood (Plasma/Serum).The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction

Thermal Cycler Compatibility :

Cal Fluor® Red 610 (Orange Channel), Quasar® 670 (Red Channel).

IVD Approved

The SARAGENE^® Covid-19 V.1 Real-Time PCR test is used for the qualitative detection of RdRp gene of SARS-CoV-2 virus that is responsible for causing Covid-19 in humans. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Sample Types used for Covid-19 V.1 :

Lower Respiratory Tract Specimens (e.g. bronchoalveolar lavage, tracheal aspirate).

Upper Respiratory Tract Specimens (e.g. nasopharyngeal, and oropharyngeal swabs).

Thermal Cycler Compatibility :

FAM^® (Green Channel) and Cal Fluor® Red 610 (Orange Channel)

IVD Approved and ICMR Approved

The SARAGENE^® Covid-19 V.2 Real-Time PCR test is used for the qualitative detection of RdRp gene & E gene of SARS-CoV-2 virus that is responsible for causing Covid-19 in humans. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Sample Types used for Covid-19 V.2 :

Lower Respiratory Tract Specimens (e.g. broncho-alveolar lavage, tracheal aspirate).

Upper Respiratory Tract Specimens (e.g. nasopharyngeal, and oropharyngeal swabs).

Thermal Cycler Compatibility :

FAM^® (Green Channel), Cal Fluor® Orange 560 (Yellow Channel), and Cal Fluor® Red 610 (Orange Channel)

IVD Approved and ICMR Approved

The SARAGENE^® Dengue Real-Time PCR (RT-PCR) test is designed to be a single step Reverse transcriptase test for detection of 1-4 types of dengue virus (IVD) from patient's blood sample. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Thermal Cycler Compatibility :

Cal Fluor® Orange 560 (Yellow Channel), and Cal Fluor® Red 610 (Orange Channel)

IVD Approved

The SARAGENE^® Human papillomavirus- High Risk Real-Time PCR (RT-PCR) test is used for detection and differentiation of HPV genotypes 16 and 18 while concurrently detecting other high risk types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction. The kit is designed to aid in the diagnosis of HPV during early or acute stages of infection to screen for high risk types of HPV that have been associated with cervical cancer.

Sample Types used for HPV HR :

Cervical samples, genital swabs, tissues, FFPE blocks and plasma or serum samples.

Thermal Cycler Compatibility :

FAM (Green), Cal Fluor® Orange 560 (Yellow Channel), Cal Fluor® Red 610 (Orange Channel), Quasar® 670 (Red Channel).

IVD Approved

The SARAGENE^® Human Papillomavirus (HPV) Genotyping test is a Real-time PCR test based on hydrolysis probe multiplexing technology, designed for the simultaneous qualitative detection and individual differentiation of all 14 high-risk HPV genotypes, including HPV 16, HPV 18, and 12 additional high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) from cervical and vaginal specimens. The test individually identifies and differentiates all 14 high-risk genotypes in a single tube reaction. The test includes an internal control targeting the Human RNaseP gene to verify sample quality, nucleic acid extraction, and reaction performance.

Sample Types used for HPV Genotyping Testing :

Cervical and Vaginal Swabs/Brush or Tissue specimens.

Thermal Cycler Compatibility :

FAM™ (Green Channel), Cal Fluor® Orange 560 (Yellow Channel), Quasar® 670 (Red Channel), Cal Fluor® Red 610 (Orange Channel).

RUO (Research Use Only)

The SARAGENE^® Human Metapneumovirus test is a Real-time PCR (RT-PCR) test designed for the qualitative detection of Human Metapneumovirus (HMPV)-specific RNA from respiratory specimens. The test targets HMPV, a prevalent cause of respiratory tract infections across all age groups, including children, adults, and the elderly. The test includes an endogenous internal control to ensure the integrity of nucleic acids, monitor amplification efficiency, and verify the quality of sample extraction.

Sample Types used for HMPV Testing :

Nasal/Throat swabs, Nasal aspirates, Broncho alveolar lavage (BAL), Sputum, and Endotracheal wash specimens.

Thermal Cycler Compatibility :

HEX/VIC (Yellow Channel), Texas Red/ROX (Orange Channel).

RUO (Research Use Only)

The SARAGENE^® H1N1 Influenza A (Swine Flu) Real-Time PCR test is used for the qualitative detection of H1N1pdm09 strain of Influenza A Virus responsible for causing swine flu pandemic in humans. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.

Thermal Cycler Compatibility :

FAM^® (Green Channel) and Cal Fluor® Red 610 (Orange Channel).

Research Use Only