Raj Biosis Private Limited

• Instant screening test

• Detects IgM anti-HAV in serum, plasma and whole blood

• Evaluated with BBI seroconversion panel (PHT903)

• Useful for identifying acute HAV infections

Product Features:

• In-house developed fourth-generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection

• Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen

• Simple assay procedure yields results within 20-25 minutes

Clinical Performance:

• Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)

• Sensitivity: 100%

• Specificity: 98.75% comparing to a commercial ELISA

• Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others

• No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)

• Use of conserved antigens allows ‘pan-filaria’ tests to be applicable

• Simple procedure provides alternative to diagnosis by blood smear

• Use serum, plasma or whole blood

• No restrictions on time of day for sample collection

The TRUSTline HCV Ab Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis C virus antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood.

• Utilizes a Core-NS3-NS4-NS5 double antigen method

• Evaluated by NIB

• Highly sensitive detection of low level titre antibodies

• Simple test procedure

• Efficient, easy-to-interpret result

• No equipment required

• Highly sensitive diagnostic test: Detects and monitors AFP levels for various conditions, including cancer.
• Chemiluminescence immunoassay: Uses a chemical reaction to produce light, enhancing sensitivity and precision.
• Multi-purpose: Suitable for various clinical applications, including routine testing, special tests, and emergent care.
• Rapid results: Provides quick results for timely diagnosis and treatment decisions.
• Multiple tests: Can be used with various Maglumi reagents for different assays.
• Workflow improvement: Streamlines the testing process and reduces manual

SD BIOLINE Rota/Adeno Ag test is a rapid immunochromatographic assay for qualitative detection of the presence of rotavirus or adenovirus antigen in human fecal specimens.

• Differentiation of test results by clear band formation (3-line)
• Test result : 20min
• Specimen : Fecal specimens(about 50mg)
• 24 months at 1-30°C

SD BIOLINE Norovirus rapid test is a rapid immunochromatographic assay for qualitative detection of the presence of norovirus antigen (Geno group I (GI) and Geno group II(GII)) in human fecal specimens. It is used as an aid in the diagnosis of acute gastroenteritis with the symptoms of suspected gastroenteritis caused by Norovirus. 

• Specimen : Fecal specimens (50-100mg)
• Test result : 15min
• 24 months at 1-30°C

SD BIOLINE Influenza Ag test detects Influenza virus type A & B respectively. Also, it detects all kinds of influenza antigen subtypes including novel influenza A(H1N1) pandemic strain.

Differential detection of Influenza virus type A & B

Human nasal swab, throat swab, nasopharyngeal swab or nasal/nasopharyngeal aspirate

Sensitivity (91.8%), specificity 99.0% vs. Viral culture and RT-PCR as gold standard

A lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human serum or plasma.

• Detects IgG, IgM and IgA antibodies facilitating accurate screening during all stages of disease

• Simple test procedure

• Efficient, easy to interpret result

• No additional equipment required

• Room temperature storage

• Utilizes Recombinant Orientia tsutsugamushi antigens.

• Qualitative detection and differentiation of antibodies(IgG and IgM) against Orientia tsutsugamushi (Scrub typhus)

• Compatible with Whole blood, Serum and Plasma.

• Sensitivity: For IgG 95.4% and IgM 96.1%, Specificity: For IgG 96.8% and IgM 97.6%.

• Results in 20 minutes.

• Meets WHO acceptance criteria

• Ease of use, requires minimal training of personnel

• Expanded testing facility options including areas where quality microscopy is not available

• Quick turnaround time to results

• Increased cost effectiveness, no high cost equipment monitoring

• Availability of Positivia external controls

• Utilizes O antigen and H antigen from both Typhi and Paratyphi serovars to maximize sensitivity

• Differentiates between IgG and IgM to determine stage of infection

• One step procedure minimizes operator error due to sample preparation

• Test result within 15 minutes allows medical professionals to take immediate action

• High level of reproducibility

• Test kits can be used and stored in a wide range of temperatures

Each Kit Contains:

• Individually sealed foil pouches containing:

  • One cassette device.

  • One desiccant

• Plastic droppers

• Sample Diluent (1 bottle, 5 mL)

• One package insert (instruction for use)

A lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM, and IgA) to Treponema pallidum (Tp) in human serum or plasma.

• Detects IgG, IgM, and IgA antibodies facilitating accurate screening during all stages of disease

• Simple test procedure

• Efficient, easy-to-interpret result

• No additional equipment required

• Room temperature storage

• Utilizes recombinant chimeric dengue virus licensed from the US CDC

• Detects all four dengue serotypes

• Duo test format minimizes processing time

• IgM detection indicates recent infection

• IgG detection indicates recent or previous infections

• Ag detection indicates a current infection

• Utilizes O antigen and H antigen from both Typhi and Paratyphi serovars to maximize sensitivity

• Differentiates between IgG and IgM to determine stage of infection

• One step procedure minimizes operator error due to sample preparation

• Test result within 15 minutes allows medical professionals to take immediate action

• High level of reproducibility

• Test kits can be used and stored in a wide range of temperatures

Each Kit Contains:

• Individually sealed foil pouches containing:

  • One cassette device.

  • One desiccant

• Stool collection devices, each containing 1 mL Fecal Sample Extraction Buffer

• Plastic droppers

• Patient ID stickers

• Sample Diluent (1 bottle, 5 mL)

• One package insert (instruction for use)

A lateral flow immunoassay for the qualitative detection of antibodies (IgG, IgM, IgA) to anti-HIV-1 & 2 virus and HIV-1 p24 antigen in human serum, plasma, or whole blood.

• 4th Generation HIV test to detect p24 in addition to IgG and IgM for early detection

• Evaluated by NIB

• Requires only 5 µL of specimen

• Use serum, plasma, or whole blood

• Results available within 15 min to allow prompt action to be taken at the point of care

• Performance validated with BBI low titre panel and Chinese FDA HIV Ab Panel

• Use of conserved antigens allows ‘pan-filaria’ tests to be applicable

• Simple procedure provides alternative to diagnosis by blood smear

• Use serum, plasma or whole blood

• No restrictions on time of day for sample collection

• Instant screening test

• Detects IgM anti-HAV in serum, plasma and whole blood

• Evaluated with BBI seroconversion panel (PHT903)

• Useful for identifying acute HAV infections

A lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma at a level equal to or higher than 0.5 ng/mL.

• Uses serum or plasma

• Evaluated by NIB

• Can be performed without the use of laboratory equipment

• Result in 15 minutes

The TRUSTline HCV Ab Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis C virus antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood.

• Utilizes a Core-NS3-NS4-NS5 double antigen method

• Evaluated by NIB

• Highly sensitive detection of low level titre antibodies

• Simple test procedure

• Efficient, easy-to-interpret result

• No equipment required

• Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market

• Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA

• Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 µmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 µmol/L; Hemoglobin: 2 g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L

• Shelf life: 24 month

The OnSite H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection of H. pylori antigen in human fecal specimen. It is a noninvasive diagnostic method and can be performed within 10 minutes by minimally skilled personnel, and without the use of laboratory equipment.

This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with H. pylori.

The OnSite H. pylori Ag Rapid Test detects antigen present in the feces by using specific antibodies, which indicates an active H. pylori infection. However, a negative test result does not preclude the possibility of infection with H. pylori. It can also be used to monitor the effectiveness of treatment and the recurrence of an infection, and is not affected by the use of Proton Pump Inhibitors (PPI). It is reported that the seroprevalence of H. pylori in specimens with positive fecal occult blood (FOB) test results is approximately 39.3%. Therefore a specimen that tests positive with an FOB test may also be tested positive with the OnSite H. pylori Ag Rapid Test. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

• Instant screening test

• Detects IgM anti-HEV in serum or plasma

• Evaluated with BBI HEV serum conversion and HEV mixed titer performance panels

• Useful for identifying acute HEV infections

• Individually sealed foil pouches containing:

  • One cassette device

  • One desiccant

• 10 µL Capillary tubes

• Sample Diluent (REF SB-R0095,5mL/bottle)

• One package insert (instruction for use)