66--OGRL LAB SAMPLING KITS
Laboratory Sampling Test Kits THIS IS A SOURCES SOUGHT NOTICE ONLY. NO FORMAL SOLICITATION IS BEING EQUESTED UNDER THIS NOTICE. This Sources Sought Notice is for market research purposes to identify i... Laboratory Sampling Test Kits THIS IS A SOURCES SOUGHT NOTICE ONLY. NO FORMAL SOLICITATION IS BEING EQUESTED UNDER THIS NOTICE. This Sources Sought Notice is for market research purposes to identify interested firms for the potential requirement detailed below. The North American Industry Classification System (NAICS) code is 325998 (All Other Miscellaneous Chemical Product and Preparation Manufacturing) and the size standard is 650 employees. The Government will review the information requested in this announcement to determine the type of set-aside (if any) for this requirement, should it come to fruition. NOTE 1: The Buy American Act (41 U.S.C. 8301-05) is the primary federal procurement law providing a preference for domestic goods and manufactured products. As such, the USGS is seeking information on sources that can supply the described instrument either mined, produced or manufactured in the U.S. in sufficient and reasonably available commercial quantities of satisfactory quality. NOTE 2: The full specifications and requirements will be provided with any solicitation that may be issued. The Government is not required to issue a solicitation. A. Introduction: The U.S. Geological Survey, (USGS) Kansas Water Science Center¿s Organic Geochemistry Research Laboratory (OGRL) has a requirement for 96-well plate enzyme-linked immunosorbent assay (ELISA) kits, cell lysis kits, and cyanotoxin standards equivalent to Gold Standard Diagnostics. B. Background: The USGS, OGRL ELISAs, cell-lysis kits, and cyanotoxin standards to support work focused on evaluating the potentially harmful effects of harmful algal bloom (HABs) toxins that are present in our Nation¿s water resources to protect public health in support of the USGS Environmental Health Mission Area Toxic Substances Hydrology Program priorities. Part of this research involves screening water samples to detect cyanotoxins. ELISA kits, cell-lysis kits, and cyanotoxin standards are essential tools in OGRL¿s research. The ELISA kits used in the OGRL act as rapid and reliable semi-quantitative screening tools for cyanotoxins. These kits have been a vital tool for cyanotoxins research and monitoring in the OGRL since at least 2003. OGRL strives to maintain national consistency in all environmental samples analyzed. The scientific analytical data from these samples is available and presented for use by other agencies and the public. It is extremely important that the supplies acquired hereunder be of high quality and will continue to provide consistency with the data that has been obtained, in some cases, for over a decade. Consistency in data is critical for the OGRL and USGS programs across the country for which the lab does analysis, and only high-quality items will allow for this. Inconsistent and inaccurate results would present an over or underestimation of the toxic dose potentially rendering people that rely on USGS¿ data for health protection to expend unnecessary resources, improperly treat toxic water bodies which costs millions of dollars for each treatment of a given waterbody or put people at unnecessary risk of toxin exposure. For this reason, it is imperative that the USGS OGRL maintain the same cross-reactivity in our ELISA measurements. Additionally, the ELISA kits currently in use by OGRL have been cross-validated against mass spectrometry. C. General Requirements: The Contractor shall provide ELISA kits, cell lysis kits, and cyanotoxin standards to meet all the salient characteristics to the OGRL. The Contractor shall be required to provide ELISA kits, cell lysis kits, and chemical standards pursuant to this contract as ordered from time-to-time during the term of this contract. The requirements and parts for each ELISA kit, cell lysing kits, and chemical standards are listed below. Several of the reagents are proprietary and every effort was made to identify what came in each kit. Listed part numbers are from Gold Standard Diagnostics. Enzyme-linked immunosorbent assays (ELISA), chemical cell lysis kits, and cyanotoxin standards are described below. The cyanotoxins that are screened using ELISA include: anatoxin-a, cylindrospermopsin, microcystin, and saxitoxins. The chemical cell lysis kits are used to lyse cells to release cyanotoxins contained within. The algal toxin standards, including dihydroanatoxin-a, homoanatoxin-a, 7-deoxy-cylindrospermopsin, 7-epi-cylindrospermopsin, 13C4-(+)-anatoxin-a; 15N5-cylindrospermopsin; 15N5-7-deoxy-cylindrospermopsin; and 15N5-7-epi-cylindrospermopsin are used for method development and to quantify cyanotoxins by high resolution mass spectrometry. D. Minimum Brand Name or Equal Salient Characteristics: 1. Anatoxin-a (VFDF) ELISA kit (p/n 520060): a. Salinity: no matrix effects noted up to 37 PPT. b. Methanol tolerance: <2.5% methanol. c. The results must be read using 450nm. The evaluation of the ELISA should be done using a 4-parameter curve fit with a 0.99 r2 as minimum acceptable curve fit. d. The plates must be 96 wells and be readable using a SprectraMax ABS Absorbance Microplate Reader. The plate wells must be optically clear and the absorbance of the blank wells at 450nm should not vary more than 5% RSD across an entire plate. e. Minimum Reporting Limit = 0.15µg/L; maximum reporting limit = 5.0µg/L. f. Cross Reactivities: (+)-anatoxin-a ¿ 100%; homoanatoxin-a ¿ 124.8%; (-)-anatoxin-a 0.3%. g. Required reagents and material: microtiter plate coated with secondary antibody; lyophilized anatoxin-a-horseradish peroxidase enzyme conjugate; conjugate diluent; lyophilized anti-anatoxin-antibody; antibody diluent; (+)-anatoxin-a calibration standards (six standards with a volume of 1ml each: 0, 0.15, 0.40, 1.0, 2.5, and 5.0µg/L); kit control standard (0.75µg/L); sample diluent (10x); wash buffer (5x); substrate (color) solution; and stop solution. h. Volume of sample required = 50µL. i. Accuracy limits: kit control standard must be ¿ ±25% of the stated value. Precision limits: the %RSD for all duplicates (blanks, controls, and samples) should be ¿ 35.4%. 2. Cylindrospermopsin ELISA kit (p/n 522011): a. Salinity: must be less than 20%. b. Methanol tolerance: <20% methanol. c. The following substances can have no significant effect on assay results: calcium chloride, magnesium chloride, magnesium sulfate, manganese sulfate, and sodium chloride up to 10,000 ppm; calcium sulfate, ferric sulfate, potassium phosphate, sodium nitrate, and zinc sulfate up to 1,000 ppm; copper chloride up to 100 ppm; Lugol¿s solution up to 0.01%. Additionally, the presence of sodium thiosulfate (up to 0.5mg/ml) and ascorbic acid (up to 1mg/ml) should not affect the assay. d. The results must be read using 450nm. The evaluation of the ELISA should be done using a 4-parameter curve fit with a 0.99 r2 as minimum acceptable curve fit. e. The plates must be 96 wells and be readable using a SpectraMax ABS Absorbance Microplate Reader. The plate wells must be optically clear and the absorbance of the blank wells at 450nm should not vary more than 5% RSD across an entire plate. f. Minimum reporting limit = 0.05µg/L; maximum reporting limit = 2.0µg/L. g. Cross reactivities: cylindrospermopsin - 100%; deoxy-cylindrospermopsin - 112%; and 7-epi-cylindrospermopsin ¿ 157%. h. Required reagents: microtiter 96 well plate; calibration standards (1.5ml each, seven in total, 0, 0.05, 0.10, 0.25, 0.50, 1.0, and 2.0µg/L); kit control (1.5ml, 0.75µg/L); sample diluent; lyophilized cylindrospermopsin-Horse Radish Peroxidase enzyme conjugate; conjugate diluent; Empty amber HDPE bottle for combining reconstituted Enzyme Conjugate; Antibody Solution (rabbit anti-Cylindrospermopsin); Wash Buffer (5X) Concentrate; Substrate (Color) Solution (TMB); and stop solution. i. Volume of sample required = 50µL. j. Accuracy limits: kit control standard must be ¿ ±25% of the stated value. Precision limits: the %RSD for all duplicates (blanks, controls, and samples) should be ¿ 35.4%. 3. Microcystin/Nodularins (ADDA) SAES ELISA kit (p/n 520011SAES): a. Salinity: no matrix effects observed up to 38 PPT salinity. b. Methanol tolerance: samples must not contain methanol concentrations > 1%. c. No matrix effects observed with samples which have been treated with sodium thiosulfate (¿ 10 mg/mL) or ascorbic acid (¿ 1 mg/mL). d. The results must be read using 450nm. The evaluation of the ELISA should be done using a 4-parameter curve fit with a 0.99 r2 as minimum acceptable curve fit. e. The plates must be 96 wells and be readable using a SpectraMax ABS Absorbance Microplate Reader. The plate wells must be optically clear and the absorbance of the blank wells at 450nm should not vary more than 5% RSD across an entire plate. f. Minimum reporting limit = 0.10µg/L; maximum reporting limit = 5.0µg/L. g. The assay must exhibit approximately equimolar cross reactivity (e.g. ~100%) for all cyanobacterial cyclic peptides toxic congeners including: microcystin-LR, microcystin-YR, microcystin-LF, desmethyl-microcystin-RR, nodularin-R, microcystin-RR, microcystin-LW, microcystin-LA and desmethyl-microcystin-LR. h. Required reagents: microtiter 96 well plate coated with analog of microcystins conjugated to a protein; calibration standard (1.5ml each, six in total: 0, 0.05, 0.15, 0.4, 1.5, 5.0µg/L); kit control (1.5ml, 0.75µg/L); Sample Diluent; Microcystins-ADDA SAES Antibody Solution; Microcystins-ADDA SAES Conjugate Solution; Wash Buffer (5X) Concentrate; Substrate (Color) Solution (TMB); and stop solution. i. Volume of sample required = 50µL. j. Accuracy limits: kit control standard must be ¿ ±25% of the stated value. Precision limits: the %RSD for all duplicates (blanks, controls, and samples) should be ¿ 35.4%. 4. Saxitoxin/Lyngbyatoxin (PSP) ELISA kit (p/n 52255B): a. Salinity: no matrix effects observed up to 27 PPT. b. Methanol tolerance: must be less than 20%. c. The results must be read using 450nm. The evaluation of the ELISA should be done using a 4-parameter curve fit with a 0.99 r2 as minimum acceptable curve fit. d. The plates must be 96 wells and be readable using a SpectraMax ABS Absorbance Microplate Reader. The plate wells must be optically clear and the absorbance of the blank wells at 450nm should not vary more than 5% RSD across an entire plate. e. Minimum reporting limit = 0.02µg/L; maximum reporting limit = 0.40µg/L. f. Cross reactivity ¿ saxitoxin -100%; Decarbamoyl STX - 29%; GTX 2 & 3 - 23%; GTX-5B - 23%; Lyngbyatoxin - 13%; Sulfo GTX 1 & 2 - 2.0%; Decarbamoyl GTX 2 & 3 - 1.4%; Neosaxitoxin - 1.3%; Decarbamoyl Neo STX - 0.6%; and GTX 1 & 4 <0.2%. g. Required reagents: Microtiter plate coated with a second antibody (anti-rabbit); calibration standards (6): 0, 0.02, 0.05, 0.1, 0.2, 0.4 ng/mL STX-diHCl, 1.5 mL each; kit control 0.075ng/mL STX-diHCl, 1.5 mL; Antibody Solution (rabbit anti-Saxitoxin); Saxitoxin- Horse Radish Peroxidase Conjugate Solution; Sample Diluent (10X) Concentrate; wash buffer (5X); substrate color solution (TMB); and stop solution. h. Volume of sample required = 50µL. i. Accuracy limits: kit control standard must be ¿ ±25% of the stated value. Precision limits: the %RSD for all duplicates (blanks, controls, and samples) should be ¿ 35.4%. 5. QuickLyse Cell lysis kit (p/n 529911): The chemical cell lysis kits are used to lyse cells to release cyanotoxins contained within cells. The AET laboratory is using an earlier NOAA validated method and therefore using the same lysing kits is vital for data comparison. The ingredients for this kit are proprietary and therefore cannot be listed here. 6. Cyanotoxin standards and isotopically labeled standards Cyanotoxin standards are used in AET laboratories to create and optimize methods and to quantitate cyanotoxins found in samples by high resolution mass spectrometry. In this laboratory, there are two methods used to quantify analytes via high resolution mass spectrometry: standard addition and isotope dilution. The toxins listed here (dihydroanatoxin-a, homoanatoxin-a, 7-deoxy-cylindrospermopsin, 7-epi-cylindrospermopsin, 13C4-(+)-anatoxin-a; 15N5-cylindrospermopsin; 15N5-7-deoxy-cylindrospermopsin; and 15N5-7-epi-cylindrospermopsin) have been purchased from the vendor we have purchased ELISA kits and cell lysing kits. The expected purity, isotope incorporation, part number, and amount are shown below. Analyte Gold Standard Minimum Isotope Concentration Diagnostic Purity Incorporation or amount/vial Part Number 13C4-(+)-anatoxin-a 300505 98% >99% 10µg/ml dihydroanatoxin-a 300655 97% -- 10µg/ml homoanatoxin-a 301295 98% -- 4µg/ml 15N5-cylindrospermopsin 300504 99% >99% 10µg/ml 15N5-7-epi-cylindrospermopsin 300506 97% >99% 5µg 15N5-7-deoxy-cylindrospermopsin 300508 88% >99% 5µg 7-epi-cylindrospermopsin 300651 96% -- 5µg 7-deoxy-cylindrospermopsin 300653 93% -- 5µg (End of Brand Name or Equal Specifications) All business concerns who believe they can responsibly provide this type of product should submit the following information to the Contracting Officer: 1. The firm shall specify the either the brand name or equal products that meets the minimum brand name or equal salient characteristics listed above along with product specification sheet and product brochure. 2. For equipment/supply requirements, business responses must include: (1) the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). 3. The firm shall specify that they are either a small business (8(a), HUBZone, SDVOSB, etc.) Or other than small business under the NAICS Code listed in the announcement. 4. The firm shall provide a point of contact name and e-mail information, and the firm¿s Cage Code, and SAM.gov UEI. NOTE 3: All information submitted in response to this announcement is voluntary ¿ the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Materials submitted to the Government for review will not be returned. Respondents will not be notified of the results of the evaluation. This is not a request for quotations. The Government does not intend to award a contract based on responses received under this announcement. In order to be responsive to this Notice, a firm must provide the appropriate documentation for consideration by February 22, 2024 at 2:30 p.m. (MDT). Responses that do not comply with these procedures will not be considered. Inquiries will only be accepted by e-mail to Lisa Williams at ldwilliams@usgs.gov
Data sourced from SAM.gov.
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