Alere Trueline Malaria Rapid Test Kit (Ag Pf/Pan — HRP2 and pLDH)
Pack Sizes Available
Product Description
Technical Specifications
- Brand / Manufacturer: Alere Trueline — manufactured by Alere Medical Pvt Ltd, India; parent platform distributed globally as Bioline Malaria Ag Pf/Pan by Abbott Diagnostics (SD Bioline); CDSCO registered IVD device; CE marked
- Test Method and Targets: One-step rapid immunochromatographic sandwich assay; dual-marker detection: (1) HRP2 — P. falciparum-specific histidine-rich protein 2; (2) Pan-pLDH — common Plasmodium lactate dehydrogenase of all 4 human Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale)
- Performance: P.f HRP2: Sensitivity 99.7%, Specificity 99.5%; Pan pLDH: Sensitivity 95.5%, Specificity 99.5% (Abbott Global Point of Care confirmed data for Bioline Malaria Ag Pf/Pan platform)
- Sample, Volume and Result Time: Sample type: human whole blood (venipuncture or fingerstick); sample volume: 5μL; result time: approximately 20 minutes; includes safety lancets and capillary pipettes for fingerstick collection
- Storage and Shelf Life: Store at 2–30°C ambient; no refrigeration required; protect from direct sunlight and moisture; shelf life: 18–24 months from manufacture; individually foil-pouched with desiccant per device
Frequently asked questions
The Alere Trueline Malaria Ag Pf/Pan test cassette has two separate test lines plus a control line. The HRP2 test line detects histidine-rich protein 2, an antigen produced exclusively by Plasmodium falciparum — the species responsible for the most severe and potentially fatal form of malaria. A positive HRP2 line confirms P. falciparum infection specifically. The pLDH (pan-pLDH) test line detects lactate dehydrogenase common to all four Plasmodium species that infect humans — P. falciparum, P. vivax, P. malariae, and P. ovale. A positive pLDH line without a positive HRP2 line indicates a non-falciparum malaria infection, most commonly P. vivax. This dual-marker result allows clinicians to differentiate malaria species and choose appropriate treatment in a single test.
P. falciparum malaria is responsible for the vast majority of malaria-related deaths globally and carries significantly higher risk of progression to severe malaria, including cerebral malaria, severe anaemia, and multi-organ failure. Treatment protocols differ between P. falciparum and non-falciparum species — specifically, artemisinin-based combination therapies (ACTs) are recommended for P. falciparum, while chloroquine remains effective for P. vivax in most regions where resistance has not developed. The ability of the Alere Trueline Pf/Pan test to distinguish P. falciparum from non-falciparum infections at the point of care enables appropriate treatment selection without waiting for laboratory microscopy, which is critical in settings where malaria mortality peaks if treatment is delayed.
Performance data confirmed by Abbott Global Point of Care (the current owner of the Bioline/Trueline malaria test line) shows P.f HRP2 sensitivity at 99.7% and specificity at 99.5%. Pan pLDH sensitivity is 95.5% and specificity is 99.5%. These figures are published on the Abbott Global Point of Care product page for the Bioline Malaria Ag Pf/Pan test, which shares the same dual-marker platform as the Alere Trueline variant manufactured in India by Alere Medical Pvt Ltd.
The Alere Trueline Malaria Ag Pf/Pan test uses human whole blood as the sample type. The sample volume required is 5μL — a very small quantity that is comfortably obtained from a fingerstick (capillary puncture) using the safety lancets included in the kit. Fingerstick blood collection eliminates the need for venipuncture equipment and trained phlebotomists, making the test suitable for use in community health worker settings, mobile screening camps, and primary care facilities without laboratory infrastructure.
The test does not require cold storage. It can be stored at ambient temperature of 2 to 30°C throughout its shelf life, which is typically 18 to 24 months from manufacture. No refrigeration is required at any point from manufacture through distribution to the end user. This is a critical logistical advantage for distribution into malaria-endemic regions across sub-Saharan Africa and Southeast Asia, where reliable cold storage infrastructure at peripheral health facility level cannot always be guaranteed. Individual test devices are foil-pouched with desiccant to maintain test integrity until the point of use.
The Alere Trueline Malaria Ag Pf/Pan is manufactured by Alere Medical Pvt Ltd, India and is CDSCO registered for sale in India as a licensed IVD diagnostic device. The parent platform — Bioline Malaria Ag Pf/Pan — distributed globally by Abbott under the SD Bioline brand, has been evaluated by WHO and appears on WHO's malaria RDT evaluation lists. CE marking for the product line is confirmed. For specific WHO prequalification status by lot number, buyers should request the current product dossier at the time of procurement as prequalification status is confirmed per product variant and version.
Microlisa HIV Ag & Ab 4th Generation ELISA Test Kit
Blood screening exists in a category of laboratory work where the margin for error is not just professionally unacceptable but medically catastrophic. A false negative in HIV screening does not just fail a test. It compromises patient safety, undermines transfusion protocols, and exposes healthcare systems to risks that nobody wants to calculate. Microlisa HIV Ag & Ab 4th Generation ELISA was engineered to close the detection window that makes early HIV infection so difficult to identify reliably. This is an in-vitro qualitative enzyme immunoassay designed for simultaneous detection of antibodies to HIV-1 (including Group O and subtype C prevalent in India), HIV-2, and HIV-1 p24 antigen in human serum or plasma. The test is intended for screening of blood donors, diagnostic testing of individuals at risk for HIV infection, and clinical evaluation of patients with AIDS-related symptoms. It represents the fourth generation of HIV ELISA technology, which detects both antibodies and antigens simultaneously rather than antibodies alone. The clinical advantage of 4th generation testing is the shortened window period. Traditional antibody-only tests miss early seroconversion cases where HIV-1 p24 antigen is present but antibodies have not yet developed to detectable levels. By detecting p24 antigen during the acute infection phase (typically 2 to 4 weeks post-exposure), this assay identifies infections approximately 1 to 2 weeks earlier than 3rd generation antibody-only tests. That earlier detection matters critically in blood donor screening and post-exposure monitoring. The assay is based on sandwich ELISA methodology. Microtiter wells are pre-coated with HIV envelope proteins (gp41, C-terminus of gp120 for HIV-1, and gp36 for HIV-2) and anti-p24 monoclonal antibodies. When specimens are added, any HIV antibodies or p24 antigen present bind to the coated antigens or antibodies. After washing, horseradish peroxidase (HRPO) conjugated antigens and anti-p24 antibodies are added, forming a sandwich complex. The colorimetric reaction develops proportionally to the amount of HIV antibodies or antigen present, read at 450nm absorbance. The kit uses color-coded reagents to monitor procedural steps, reducing protocol errors during multi-step workflows. Breakaway microwell strips allow testing flexibility from single specimens to full 96-well plate runs. Storage stability is maintained at 2-8°C with a shelf life of 24 months unopened. Total assay time including incubation steps is approximately 120 minutes. Sensitivity and specificity meet international standards for 4th generation HIV screening. Clinical evaluations demonstrate 100% sensitivity in detecting seroconversion panels and p24 antigen standards quantified down to 200 pg/ml. Specificity exceeds 99.5% when tested against large sample populations. The test detects all major HIV-1 subtypes including Group O and subtype C, which are epidemiologically significant in the Indian subcontinent. For distributors supplying blood banks, transfusion centers, diagnostic laboratories, and public health screening programs, Microlisa HIV Ag & Ab represents a clinically validated 4th generation screening platform with predictable reorder cycles. Sara Wellness has been exporting in-vitro diagnostic kits and laboratory reagents from India for 15 years.
Advantage PAN Malaria Card Rapid Diagnostic Test Kit
Malaria diagnosis in endemic regions operates under time pressure that microscopy cannot always accommodate. A patient presenting with fever in a rural health center at midnight does not have the luxury of waiting until morning for a trained microscopist to arrive, prepare slides, and spend twenty minutes examining blood films under oil immersion. That delay can mean the difference between timely artemisinin treatment and cerebral malaria developing overnight. Advantage PAN Malaria Card was designed to deliver species-level diagnosis in settings where microscopy is impractical or unavailable. This is a rapid visual immunoassay for qualitative detection of all four human Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) based on pan-specific plasmodium lactate dehydrogenase (pLDH) antigen in whole blood. The test provides results within 20 minutes using a simple fingerstick blood sample, no laboratory equipment required, making it ideal for point-of-care testing in primary health centers, rural clinics, field hospitals, and outbreak response settings. The assay is based on sandwich immunochromatography using monoclonal antibodies specific to pLDH, an enzyme produced by all Plasmodium species during their erythrocytic life cycle. When infected blood is added to the test device and assay buffer is applied, red blood cells lyse and pLDH antigen (if present) binds to gold-conjugated anti-pLDH antibodies. This complex migrates along the nitrocellulose membrane and is captured by immobilized anti-pLDH antibodies at the test line, producing a visible pink-purple band that confirms malaria infection. The see-through device design allows direct visualization of sample migration and result development, which helps identify invalid tests caused by insufficient sample volume or improper application. This transparency reduces the ambiguity that plagues some lateral flow devices where internal workings are hidden. Sensitivity and specificity have been validated through WHO malaria RDT evaluation programs using panels of wild and cultured parasites. The test detects parasitemia levels above 100 parasites per microliter of blood for both P. falciparum and P. vivax, which is clinically relevant for symptomatic infections requiring treatment. Specificity exceeds 99% when tested against cross-reactive conditions including dengue, leptospirosis, typhoid, and other febrile illnesses common in malaria-endemic areas. Shelf life is 24 to 30 months when stored at 4-30°C, which is critical for stockpiling in tropical climates where cold chain infrastructure is unreliable. The extended temperature stability means the test remains functional even when stored at ambient temperatures in resource-limited settings. Each kit contains individually sealed test devices, buffer vials, blood collection pipettes, and instructions for use. The test requires no special training beyond basic clinical skills and can be performed by nurses, paramedics, or trained community health workers. For distributors supplying national malaria control programs, public health departments, NGO field operations, and private diagnostic laboratories, Advantage PAN Malaria Card represents a WHO-evaluated rapid diagnostic platform with predictable consumption tied to malaria case loads. Sara Wellness has been exporting rapid diagnostic test kits and laboratory reagents from India for 15 years.
Human Serum Coombs Antisera (Antihuman Globulin Reagent)
Blood banking operates on a fundamental requirement that most people never think about until something goes wrong. Every unit of blood transfused must be confirmed compatible with the recipient's immune system. Every pregnant woman screened for antibodies that could harm her unborn child. Every suspected case of hemolytic anemia investigated for antibodies attacking the patient's own red blood cells. None of this happens without Coombs antisera making the invisible antibodies visible. Human Serum Coombs Antisera is the reagent that makes antiglobulin testing possible in blood banks and immunohematology laboratories worldwide. This is antihuman globulin (AHG) reagent used in both direct and indirect antiglobulin tests (Coombs tests) to detect antibodies and complement components bound to red blood cell surfaces or present free in serum. The reagent is produced by immunizing animals (typically rabbits) with human immunoglobulins, which induces production of polyclonal antibodies specific for human IgG antibodies and complement factor C3d. When added to washed red blood cells coated with IgG or complement, the antihuman antibodies bind to the human antibodies and form bridges between adjacent sensitized cells, causing visible agglutination. The direct antiglobulin test (DAT) detects antibodies or complement already bound to red blood cell surfaces in vivo. This test is critical for diagnosing autoimmune hemolytic anemia, investigating hemolytic transfusion reactions, and diagnosing hemolytic disease of the fetus and newborn. The indirect antiglobulin test (IAT) detects free antibodies circulating in serum or plasma. This test is essential for pre-transfusion antibody screening, crossmatching blood units for compatibility, and prenatal antibody screening in pregnant women. Polyspecific Coombs antisera (like the green-colored reagent shown) contains antibodies against both IgG and C3d complement, providing broad-spectrum detection. When the polyspecific reagent produces a positive result, monospecific antisera (anti-IgG alone or anti-C3d alone) are used for follow-up testing to characterize whether red cells are coated with IgG antibodies, complement, or both. This differentiation is clinically important because it helps determine the cause and clinical significance of the positive test. The reagent is typically dyed green using patent blue and tartrazine to allow easy visual identification during laboratory workflows where multiple reagents are used simultaneously. Storage at 2-8°C maintains reagent potency until the expiration date printed on the bottle, typically 18 to 24 months from manufacture. The reagent contains sodium azide (0.1% w/v) as a preservative, which inhibits bacterial growth but requires careful handling and disposal. Each dropper bottle delivers approximately 40 microliters per drop, allowing precise volumetric dosing during testing. The reagent must not be diluted and should not be used if turbid, as turbidity indicates bacterial contamination or protein aggregation that will compromise test performance. For distributors supplying blood banks, hospital transfusion services, reference immunohematology laboratories, and donor screening centers, Coombs antisera represents an essential reagent with consumption directly tied to transfusion volume and prenatal screening programs. Sara Wellness has been exporting immunohematology reagents and blood banking supplies from India for 15 years.