DRUG ASSAYS

KRIBIOLISA™ Rituximab (RITUXAN®) ELISA

KRIBIOLISA™ Infliximab (REMICADE®) ELISA
KRIBIOLISA™ Alemtuzumab (LEMTRADA®) ELISA
KRIBIOLISA™ Etarnacept (ENBREL®) ELISA
KRIBIOLISA™ Ustekinumab (STELARA®) ELISA THE FOREFRONT OF BIOLOGICS MONITORING
KRIBIOLISA™ Adalimumab (HUMIRA®)ELISA
KRIBIOLISA™ Bevacuzimab (AVASTIN®) ELISA
KRIBIOLISA™ Trastuzumab (HERCEPTIN) ELISA
KRIBIOLISA™ Humanized Anti-Her2/neu (Herceptin/Trastuzumab) ELISA

* ® all trade marks and registered brands are of their respective own-
KRIBIOLISA™ Cetuximab (ERBITUX®) ELISA
KRIBIOLISA™ Golimumab (SIMPONI®) ELISA
KRIBIOLISA™ Natalizumab (TYSABRI®) ELISA
KRIBIOLISA™ Omalizumab (XOLAIR®) ELISA
KRIBIOLISA™ Tocilizuma b (ACTEMRA®) ELISA
KRIBIOLISA™ Eculizumab (SOLIRIS®) ELISA
KRIBIOLISA™ Ipilimumab (YERVOY®) ELISA
KRIBIOLISA™ Denosumab (PROLIA®) ELISA
KRIBIOLISA™ Atezolizumab (TECENTRIQ®) ELISA
KRIBIOLISA™ Daratumumab (DARZALEX®) ELISA
KRIBIOLISA™ Ranibizumab (LUCENTIS®) ELISA

ANTI-DRUG ANTIBODY ASSAYS

KRIBIOLISA™ Anti-Rituximab (RITUXAN®) ELISA
KRIBIOLISA™ Anti-Infliximab (REMICADE®) ELISA
KRIBIOLISA™ Anti-Alemtuzumab (LEMTRADA®) ELISA
KRIBIOLISA™ Anti-Etarnacept (ENBREL®) ELISA
KRIBIOLISA™ Anti-Ustekinumab (STELARA®) ELISA
KRIBIOLISA™ Anti-Adalimumab (HUMIRA®)ELISA
KRIBIOLISA™ Anti-Bevacuzimab (AVASTIN®) ELISA
KRIBIOLISA™ Anti-Trastuzumab (HERCEPTIN®) ELISA
KRIBIOLISA™ Anti-Cetuximab (ERBITUX®) ELISA
KRIBIOLISA™ Anti-Golimumab (SIMPONI®) ELISA
KRIBIOLISA™ Anti-Natalizumab (TYSABRI®) ELISA
KRIBIOLISA™ Anti-Omalizumab (XOLAIR®) ELISA
KRIBIOLISA™ Anti-Tociliz umab (ACTEMRA®) ELISA
KRIBIOLISA™ Anti Eculizumab (SOLIRIS®) ELISA
KRIBIOLISA™ Anti-Ipilimumab (YERVOY®) ELISA
KRIBIOLISA™ Anti-Denosumab (PROLIA®) ELISA
KRIBIOLISA™ Anti-Atezolizumab (TECENTRIQ®) ELISA
KRIBIOLISA™ Anti-Daratumumab (DARZALEX®) ELISA
KRIBIOLISA™
ASSAY KITS
PD-1 / PD-L1
KRIBIOLISA™ is the Registered TradeMark of KRISHGEN BIOSYSTEMS KRIBIOLISA PD-1 ELISA

KRIBIOLISA PD-L1 ELISA

USA: 3380 Paseo Drive, Brea, CA 92823 | email: info@krishgen.com | tel: 213-2913096

India: Unit Nos#318/319, Shah & Nahar, Off Dr E Moses Road, Worli, Mumbai 400018. | email: sales@krishgen.com | tel: 22-49198700
 OUR PHILOSOPHY IS TO DELIVER THE BEST ASSAY AND
TOOLS FOR YOUR SCIENCE.
ASSAY KIT PARTICULARS :

KRIBIOLISA™ PD-1 ELISA KRIBIOLISA™ PD-L1 ELISA

KIT CATALOG NUMBER: KBBA50 KIT CATALOG NUMBER: KBBA52
TYPE OF ASSAY: ELISA, SANDWICH BASED TYPE OF ASSAY: ELISA, SANDWICH
SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE SAMPLE MATRIX: SERUM, PLASMA, CELL CULTURE
SUPERNATANT SUPERNATANT
CALIBRATOR RANGE: 0 - 10 NG/ML CALIBRATOR RANGE: 0 - 5 NG/ML

REGULATORY STATUS: REGULATORY STATUS:

IN USA : FOR RESEARCH USE IN USA : FOR RESEARCH USE
IN EUROPE : FOR RESEARCH USE IN EUROPE : FOR RESEARCH USE

VALIDATION: AS PER ICH AND FDA GUIDELINES FOR BIOLOGICAL ASSAYS

KRIBIOLISA™PD-1 ELISA
KRIBIOLISA™PD-L1 ELISA
High Sensitivity Assays:
Limit of Detection: 0.15 NG/ML Seven Point Calibration Curve
0.07 NG/ML for High Degree Of Accuracy

PD-1
PD-L1 PRINCIPAL OF THE ASSAY + KIT PARAMETERS

Drug Class: Immune Checkpoint KRIBIOLISA™ PD-1 ELISA

PD-1
Programmed Cell Death-1 (PD-1) is a receptor that is elevated on activat-
ed T cells, B cells and macrophages. PD-1 is a checkpoint co-inhibitor of
T cell-associated immune response. When T cell receptor (TCR) engages
with the foreign/cancer antigen, PD-1 is joined with its ligand, pro-
grammed death ligand-1 (PD-L1) on the antigen presenting cells simulta-
neously and triggers an inhibitory signal to suppress IL-2 production and
antigen specific CD8+ T cell proliferation. In addition, PD-1/PDL-1 binding
promotes regulatory T cells (Tregs) development and function. PD-L1 is
expressed abundantly in immune-privileged organs such as placenta,
eyes and testes and plays a role in tolerance.
Upregulation of PD-L1 has been found in many cancer types, such as bladder cancer, non-small cell lung cancer
(NSCLC), renal cancer, melanoma, ovarian cancer, and breast cancer. Evidences showed that the PD-1/PD-L1
pathway is associated with autoimmunity, cancer’s immune evasion, the antigen-specific CD4+ T cell exhaustion
during some chronic infection, and neurodegeneration in Alzheimer’s disease. PD-L2, another ligand of PD-1, is
mainly expressed in macrophages and dendritic cells and has a low constitutive basal expression. PD-L2 plays a
role in modulation of Th2 type of immune response, while PD-L1 is an important negative regulator to Th1 re-
sponse which is more relevant to cancer immunity. Soluble PD-1 (sPD-1) can be detected in blood.
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to PD-1 are precoated onto
microwells. Samples and standards are pipetted into microwells and PD-1 present in the sample are bound by the capture
antibody. Then, a HRP (horseradish peroxidase) conjugated antibody against PD-1 is pipetted and incubated. After wash-
ing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to mi-
crowells and color develops proportionally to the amount of PD-1 in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.
KRIBIOLISA™ PD-L1 ELISA
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to PD-1 are precoated onto
microwells. Samples and standards are pipetted into microwells and PD-1 present in the sample are bound by the capture
antibody. Then, a HRP (horseradish peroxidase) conjugated antibody against PD-1 is pipetted and incubated. After wash-
ing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to mi-
crowells and color develops proportionally to the amount of PD-1 in the sample. Color development is then stopped by
addition of stop solution. Absorbance is measured at 450 nm.
CALIBRATORS VALIDATION + KIT PARAMETERS
KRIBIOLISA™ PD-1 ELISA
The Calibrators have been standardized against PD-1 protein sourced commercially.

PD-L1 KRIBIOLISA™ PD-L1 ELISA

The Calibrators have been standardized against antibodies to PD-L1 protein sourced commercially.
Programmed Death-Ligand 1 (PD-L1) is a 40KD type I transmembrane protein found on various hematopoietic and non-
hematopoietic cells. PD-L1 and its receptor Programmed Death-1 (PD-1) are members in the extended B7/CD28 co-
stimulator superfamily of T cell immunity regulators. PD-1 is expressed by activated T-cell, pro B-cell and macrophage.
When the T-cell receptor (TCR) on activated T-cell engages with antigen presented by MHC, the binding of PD-1 on activat-
ed T-cell with PD-L1 on the antigen presenting cells occurs simultaneously. The ligation triggers the recruitment of Src ho- PERFORMANCE CHARACTERISTICS + KIT PARAMETERS
mology region 2 domain containing phosphatase 1 (SHP) and SHP-2 (Chemnitz et al., 2004) through the immunereceptor
tyrosine-based switch motif (ITSM) on the PD-1 cytoplasmic tail. The PD-L1/PD-1 pathway is thought to have a self-
protective function, which is exploited by tumor cells and chronic infectious agents to escape immunity (Riley, 2009). Upreg- KRIBIOLISA™ PD-1 ELISA
ulation of PD-L1 has been found to be associated with many cancer types, such as bladder cancer, non-small cell lung can- Sensitivity (LOD) : 0.15 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: PD-1, 100%
cer (NSCLC), renal cancer, melanoma, ovarian cancer, and breast cancer. High PD-L1 levels are related to tumor aggres-
KRIBIOLISA™ PD-L1 ELISA
siveness and higher mortality in patients with renal cell carcinoma, and related to significantly poorer prognosis and lower Sensitivity (LOD) : 0.07 NG/ML Precision: Inter/Intra Assay: < 10% Cross Reactivity: PD-L1, 100%
intraepithelial CD8+ T-lymphocyte count in patience with ovarian cancer. PD-L1 is also believed to play a role in the genera-
tion of regulatory T cells (Tregs), and in the enhancement of Treg cell function. PD-L1 co-stimulation can down-regulate the
ligand induced T-cell receptor on CD8+ T-cells.