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.
Pulmonary (Respiratory) and Extra-pulmonary (Non-Respiratory) samples.
FAM® (Green), Cal Fluor® Orange 560 (Yellow Channel), Cal Fluor® Red 610 (Orange Channel).
IVD Approved
The SARAGENE® Malaria 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.
FAM® (Green), Cal Fluor® Red 610 (Orange Channel)
IVD Approved
The SARAGENE® Hepatitis B Virus (HBV) 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.
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.
Quasar® 670 (Red Channel), Cal Fluor® Red 610 (Orange Channel)
Validated against WHO International Standard for Hepatitis C
IVD Approved
The SARAGENE® Human papillomavirus (HPV) 16/18 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.
Cervical samples, genital swabs, tissues, FFPE blocks, and plasma or serum samples.
FAM® (Green), Cal Fluor® Orange 560 (Yellow Channel), Cal Fluor® Red 610 (Orange 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.
Lower Respiratory Tract Specimens (e.g. bronchoalveolar lavage, tracheal aspirate).
Upper Respiratory Tract Specimens (e.g. nasopharyngeal, and oropharyngeal swabs).
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.
Lower Respiratory Tract Specimens (e.g. broncho-alveolar lavage, tracheal aspirate).
Upper Respiratory Tract Specimens (e.g. nasopharyngeal, and oropharyngeal swabs).
FAM® (Green Channel), Cal Fluor® Orange 560 (Yellow Channel), and Cal Fluor® Red 610 (Orange Channel)
IVD Approved and ICMR 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 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
Cal Fluor® Red 610 (Orange Channel), Quasar® 670 (Red Channel).
IVD 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 from patient's blood sample. The test includes an internal control to identify possible qPCR inhibition and verify the quality of sample extraction.
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.
Cervical samples, genital swabs, tissues, FFPE blocks and plasma or serum samples.
FAM (Green), Cal Fluor® Orange 560 (Yellow Channel), Cal Fluor® Red 610 (Orange Channel), Quasar® 670 (Red Channel).
IVD Approved
The SARAGENE® Drug Resistant Tuberculosis (DRTB) Test is a qualitative RUO screening test for the presence or absence of mutations associated with Rifampicin and/or Isoniazid drug resistance caused by in patients who have been previously diagnosed with tuberculosis infection.
The test is designed to identify mutations in rpoB_516, rpoB_526, rpoB_527_534, rpoB_491, inhA, and katG genes.
Pulmonary and Extra-Pulmonary Samples.
EvaGreen® (Green Channel)
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.
FAM® (Green Channel) and Cal Fluor® Red 610 (Orange Channel).
Research Use Only
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