WO2020049566A1 - Strep testing methods - Google Patents

Strep testing methods Download PDF

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Publication number
WO2020049566A1
WO2020049566A1 PCT/IL2019/050994 IL2019050994W WO2020049566A1 WO 2020049566 A1 WO2020049566 A1 WO 2020049566A1 IL 2019050994 W IL2019050994 W IL 2019050994W WO 2020049566 A1 WO2020049566 A1 WO 2020049566A1
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WIPO (PCT)
Prior art keywords
rst
saliva
alere
patient
technique
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Application number
PCT/IL2019/050994
Other languages
French (fr)
Inventor
Lazar Fruchter
Leah FORGOSH
Boaz Arieli
Original Assignee
Hero Scientific Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hero Scientific Ltd. filed Critical Hero Scientific Ltd.
Publication of WO2020049566A1 publication Critical patent/WO2020049566A1/en

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6888Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
    • C12Q1/689Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay

Definitions

  • Fig. 2 is a flowchart depicting a method for using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, for testing an unincubated sample of saliva not swabbed from a patient's throat for the presence of GAS, in accordance with some applications of the present invention;
  • a highly sensitive RST technique such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique
  • Clinical Trial data of the GAS amount found in total gargle from all 28 patients enrolled during phase 2 indicates that a 0.2 mL sample of unfiltered, unincubated gargle can be used with AlereTM i technology for detection of GAS, as can be seen in Table 1A, Table 1B, and Table 1C of Figs. 3A/1-3A/2, 3B, and 3C, respectively.
  • the data in Table 1 A represent the projected likelihood that AlereTM i technology is sensitive enough to detect GAS from a sample of unfiltered gargle without incubation.
  • the total GAS found in each gargle was used to determine how much GAS would be found in 0.1 mL and 0.2 mL gargle samples.
  • the average LOD of the AlereTM i device was used as the baseline for projected likelihood for whether testing the sample with AlereTM i would have yielded a positive or negative result.

Abstract

A method is provided, including receiving (24), from a patient, saliva not swabbed from the patient's throat. A rapid strep test (RST) is performed (26) on at least a portion of the saliva using a nucleic acid detection RST technique. The method does not include incubating the saliva before performing the RST. Other embodiments are also described.

Description

STREP TESTING METHODS
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application claims priority from US Provisional Application 62/727,208, filed September 5, 2018, which is assigned to the assignee of the present application and incorporated herein by reference.
FIELD OF THE INVENTION
Applications of the present invention relate to testing for the presence of particulates, such as bacteria, in fluids.
BACKGROUND
Streptococcal pharyngitis, streptococcal tonsillitis, or streptococcal sore throat (known colloquially as strep throat) is a type of pharyngitis caused by group A beta hemolytic streptococcus bacteria. Common symptoms include fever, sore throat, and enlarged cervical lymph nodes.
The rapid strep test is commonly used to test for the presence of group A streptococcus bacteria. In this test, a swab is streaked across the throat to collect bacteria, and is subsequently inserted into an extraction solution. The extraction solution extracts strep A carbohydrate antigen from the bacteria. A dipstick containing an antibody specific to strep A carbohydrate antigen is inserted into the mixture containing the antigen. The mixture migrates up the dipstick and reacts with the antibody, thus generating a line on the dipstick. The presence of this line indicates a positive test result.
Alere™ i (Abbott Laboratories, Waltham, Massachusetts, USA) is a fast and sensitive device for the rapid qualitative detection of Group A Streptococcal ("GAS") pharyngitis from throat swab samples, which utilizes a method of isothermal amplification and has a known low limit of detection (LOD). Alere™ i was recently renamed ID NOW™ Strep A 2.
SUMMARY OF THE INVENTION
In accordance with some applications of the present invention, a method is disclosed for receiving gargled fluid from a patient and testing for the presence of Group A Streptococcal ("GAS") bacteria by performing a rapid strep test (RST) on at least a portion of the gargled fluid, without first incubating the gargled fluid, using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, such as isothermal amplification, e.g., using Alere™ i, or real-time quantitative polymerase chain reaction (qPCR) assaying. Examples of nucleic acid detection techniques that do not involve nucleic acid amplification include nucleic acid nano-sensors and molecular hybridization techniques.
In accordance with other applications of the present invention, a method is disclosed for receiving saliva not swabbed from a patient's throat and testing for the presence of Group A Streptococcal ("GAS") bacteria by performing a rapid strep test (RST) on at least a portion of the saliva, without first incubating the saliva, using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, such as isothermal amplification, e.g., using Alere™ i, or real-time (qPCR) assaying. For some applications, the patient sucks on an absorbent element, e.g., a swab, or the absorbent element, e.g., swab is rubbed on the patient's tongue and/or cheek. In this manner, the saliva is received on the absorbent element, e.g., swab, e.g., a flocked swab, a cotton swab, or a polyester swab, from the patient's mouth, without swabbing the patient's throat. Alternatively, the saliva may be spit by the patient.
There is therefore provided, in accordance with some applications of the present invention, a method including:
receiving gargled fluid from a patient; and
performing a rapid strep test (RST) on at least a portion of the gargled fluid using a nucleic acid detection RST technique,
wherein the method does not include incubating the gargled fluid before performing the RST.
For some applications, performing the RST includes performing the RST on at least a portion of the gargled fluid using a nucleic acid amplification technique selected from the group consisting of: isothermal amplification and real-time polymerase chain reaction (qPCR) assaying.
For some applications, the RST technique is isothermal amplification.
For some applications, the RST technique is qPCR.
There is further provided, in accordance with some applications of the present invention, a method including:
receiving, from a patient, saliva not swabbed from the patient's throat; and performing a rapid strep test (RST) on at least a portion of the saliva using a nucleic acid detection RST technique,
wherein the method does not include incubating the saliva before performing the
RST.
For some applications, performing the RST includes performing the RST on at least a portion of the saliva using a nucleic acid amplification technique selected from the group consisting of: isothermal amplification and real-time polymerase chain reaction (qPCR) assaying.
For some applications, the RST technique is isothermal amplification.
For some applications, the RST technique is qPCR.
For some applications, receiving the saliva from the patient includes receiving saliva spit by the patient.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a flowchart depicting a method for using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, for testing an unincubated sample of gargled fluid for the presence of GAS, in accordance with some applications of the present invention;
Fig. 2 is a flowchart depicting a method for using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, for testing an unincubated sample of saliva not swabbed from a patient's throat for the presence of GAS, in accordance with some applications of the present invention;
Figs. 3A/1-3A/2, 3B, and 3C are tables that present results of an experiment conducted in accordance with an application of the present invention; and
Figs. 4A/1-4A/2 and 4B are tables that present additional results of the experiment conducted in accordance with an application of the present invention. DETAILED DESCRIPTION
Reference is now made to Fig. 1, which is a flowchart depicting a method for using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, such as isothermal amplification, e.g., using Alere™ i, or real-time (qPCR) assaying, for testing an unincubated sample of gargled fluid for the presence of GAS, in accordance with some applications of the present invention. In step 20 gargled fluid is received from a patient, and in step 22 an RST is performed on at least a portion of the gargled fluid, without first incubating the gargled fluid, by using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, such as isothermal amplification, e.g., using Alere™ i, or real-time (qPCR) assaying. Examples of nucleic acid detection techniques that do not involve nucleic acid amplification include nucleic acid nano-sensors and molecular hybridization techniques.
Results of a clinical trial performed by the inventors, including 28 patients, are shown in Tables 1A, IB, and 1C of Figs. 3A/1-3A/2, 3B, and 3C, respectively, of the experimental data set forth hereinbelow in the section entitled, "Measuring Group A Beta- Hemolytic Streptococcus Bacteria in Throat Gargle: Use of Alere™ i Technology for Fast Results without Filtration or Incubation.". Gargled fluid was collected from each of the 28 patients and inoculated onto blood plates. Beta-hemolytic colonies were counted using a light table. The total number of GAS in each sample of gargle fluid was used to determine how much GAS would be in 0.1 mL and 0.2 mL samples, respectively. The average limit of detection (LOD) of the Alere™ i device was used as the baseline for projecting a likelihood of whether testing the sample with Alere™ i would have yielded a positive or negative result.
As shown in Tables 1A and IB, when 0.1 mL of gargled fluid was used, the projected Alere™ i sensitivity was 84.2%, the data showing 16 projected true positives (i.e., a positive projected result with Alere™ i for a clinically GAS -positive patient), 9 projected true negative, and 3 projected false negatives (i.e., a negative projected result with Alere™ i for a clinically GAS-positive patient). As shown in Tables 1A and 1C, when 0.2 mL of gargled fluid was used, the projected Alere™ i sensitivity was 100%, the data showing 19 true positives and 9 true negative.
In light of these results, the projected results for testing a 0.1 mL sample of unfiltered, unincubated gargled fluid with Alere™ i are largely successful, and therefore the scope of the present invention includes at least a 0.1 mL, e.g., 0.15 mL, e.g., 0.2 mL, sample.
Reference is now made to Fig. 2, which is a flowchart depicting a method for using a highly sensitive RST technique, such as a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, such as isothermal amplification, e.g., using Alere™ i, or real-time (qPCR) assaying, for testing an unincubated sample of saliva not swabbed from a patient's throat for the presence of GAS, in accordance with some applications of the present invention. In step 24 saliva not swabbed from the patient's throat (i.e., saliva collected without swabbing the patient's throat) is received from a patient. (The distinction between "swab" as a verb and as a noun is noted. A "swab" (as a noun) may be used to obtain saliva without "swabbing" (as a verb) the patient's throat. For example, the patient may suck on a swab, or a swab may be dipped in a container into which gargle fluid or saliva has been placed.) In step 26 an RST is performed on at least a portion of the saliva, without first incubating the saliva, by using a nucleic acid detection RST technique, e.g., a nucleic acid amplification RST technique, such as isothermal amplification, e.g., using Alere™ i, or real-time (qPCR) assaying. For some applications, the patient sucks on an absorbent element, e.g., a swab, or the absorbent element, e.g., swab, is rubbed on the patient's tongue and/or cheek. In this manner, the saliva is received on the absorbent element, e.g., swab, e.g., a flocked swab, a cotton swab, or a polyester swab, from the patient's mouth, without swabbing the patient's throat.
Results of a clinical trial performed by the inventors, including twenty eight patients, are shown in Tables 2A and 2B of Figs. 4A/1-4A/2 and 4B, respectively, of the experimental data set forth hereinbelow in the section entitled, "Measuring Group A Beta- Hemolytic Streptococcus Bacteria in Saliva Sample: Use of Alere™ i Technology for Fast Results without Incubation." Twenty-eight patients were asked to suck on a flocked swab for about ten seconds. The saliva swabs were then inoculated onto blood plates, and beta- hemolytic colonies were counted using a light table. As illustrated by Table 2 A in the experimental data set forth in hereinbelow in the section entitled, "Measuring Group A Beta-Hemolytic Streptococcus Bacteria in Saliva Sample: Use of Alere™ i Technology for Fast Results without Incubation," all the saliva swabs from subjects who were clinically GAS-positive were found to contain a number of colony-forming units (CFUs) of GAS ranging from four to "too numerous to count." Using the GAS count from each of the blood plates and based on the average LOD of the Alere™ i, the projected Alere™ i sensitivity was 76.3%, the data showing 14 projected true positives (i.e., a positive projected result with Alere™ i for a clinically GAS- positive patient), nine projected true negative, 4 projected false negatives (i.e., a negative projected result with Alere™ i for a clinically GAS-positive patient), and one maybe. It is noted that in the sensitivity percentage calculation in Table 2B the "maybe" result is taken into consideration as 0.5 true positive and 0.5 true negative. Due to not being able to transfer all the saliva from a saliva swab to a blood plate, the GAS found on each saliva swab plate, as shown in Table 2 A, is an underestimation for the total amount of GAS contained in each saliva swab that would be available for analysis using Alere™ i.
In light of these results, the projected results for testing saliva swabs, without incubation, with Alere™ i are largely successful, especially given that the amount of the GAS used to generate the projected results for each blood plate is an underestimation of how much GAS was actually contained in each saliva swab that would be available for analysis using Alere™ i.
Measuring Group A Beta-Hemolytic Streptococcus Bacteria in Throat Gargle:
Use of Alere™ i Technology for Fast Results without Filtration or Incubation
In some applications of the present invention, the amount of group A streptococcus bacteria (GAS) present in throat gargles can be determined by culturing a sample of gargle fluid and culturing limiting dilutions of gargle fluid for colony counting. This assessment of total GAS in gargle can be used to estimate if a detection method with a known limit of detection ("LOD") would likely be able to detect GAS in a gargle sample.
Alere™ i is a fast and sensitive device for the rapid qualitative detection of GAS from throat swab samples, which utilizes a method of isothermal amplification and has a known low LOD (Alere™ i average LOD = 28 CFUs).
In a clinical experiment performed by the inventors, the use of Alere™ i technology for the detection of GAS from a sample of unfiltered throat gargle without incubation was tested. The Clinical Trial data is based on throat gargles obtained from patients with GAS pharyngitis who were enrolled in phase 2 of a Proof of Concept Clinical Trial (Protocol Number: STRP.P001, SNIH Clinical Trial Number: NCT03231098, Helsinki IRB Number: SZMC-0181-17). Materials and Methods
Growth conditions: The bacteria were routinely grown in a 37°C incubator, without agitation. Cultures were incubated for 12-75 hours.
Blood plate culture media: Standard 90 mm plate (Petri dishes) containing TSA + 5% sheep blood. Blood plates were purchased from Hylabs (Rehovot, Israel, Cat No. PD- 049).
Throat gargle: Throat gargles were obtained from patients enrolled in the phase 2 of the Clinical Trial by gargling 10-11 mL PBS for approximately 10 seconds.
Bacterial counts: 0.1 mL samples of throat gargles were inoculated onto blood plates without dilution and with using the appropriate limiting dilutions (dilutions of 10- fold to lOO-fold) and beta-hemolytic colonies were counted using a light table.
Summary of Results
Clinical Trial data of the GAS amount found in total gargle from all 28 patients enrolled during phase 2 indicates that a 0.2 mL sample of unfiltered, unincubated gargle can be used with Alere™ i technology for detection of GAS, as can be seen in Table 1A, Table 1B, and Table 1C of Figs. 3A/1-3A/2, 3B, and 3C, respectively. The data in Table 1 A represent the projected likelihood that Alere™ i technology is sensitive enough to detect GAS from a sample of unfiltered gargle without incubation. The total GAS found in each gargle was used to determine how much GAS would be found in 0.1 mL and 0.2 mL gargle samples. The average LOD of the Alere™ i device was used as the baseline for projected likelihood for whether testing the sample with Alere™ i would have yielded a positive or negative result.
As shown in Table 1B, if 0.1 mL gargle samples would have been tested using Alere™ i from the 28 patients in phase 2 of the Clinical Trial, it is likely that there would have been 16 true positives, 9 true negative, and 3 false negatives, resulting in a projected 84.2% sensitivity.
As shown in Table 1C, if 0.2 mL gargle sample would have been tested using Alere™ i from these 28 patients, it is likely that there would have been 19 true positives and 9 true negative, resulting in a projected 100% sensitivity.
These data support of the use of Alere™ i and other highly sensitive rapid detection methods with low LOD (including PCR-based methods) for use in identifying the presence of GAS in a sample of unfiltered throat gargle without incubation. Based on the gargle data from 28 patients enrolled in the Clinical Trial, the use of 0.2 mL gargle sample or greater is estimated to be sufficient to yield a positive result with high sensitivity when tested with the Alere™ i device.
Measuring Group A Beta-Hemolytic Streptococcus Bacteria in Saliva Sample:
Use of Alere™ i Technology for Fast Results without Incubation
In some applications of the present invention, the amount of group A streptococcus bacteria (GAS) present in saliva swab samples can be partially determined by culturing the saliva swab for colony counting. This assessment is only a partial determination of the total GAS present in the saliva swab, because culturing on a plate does not effectively remove all bacteria from a swab in comparison to complete emersion of swab in an elution buffer. However, this assessment can be used to form a rough estimate whether a detection method with a known limit of detection ("LOD") would likely be able to detect GAS in the saliva sample.
Alere™ i is a fast and sensitive device for the rapid qualitative detection of GAS from throat swab samples, which utilizes a method of isothermal amplification and has a known low LOD (Alere™ i average LOD = 28 CFUs).
In a clinical experiment performed by the inventors, the use of Alere™ i technology for the detection of GAS from unincubated saliva swab samples was tested. The Clinical Trial data is based on throat gargles obtained from patients with GAS pharyngitis who were enrolled in phase 2 of a Proof of Concept Clinical Trial (Protocol Number: STRP.P001, SNIH Clinical Trial Number: NCT03231098, Helsinki IRB Number: SZMC -0181-17).
Materials and Methods
Growth conditions : The bacteria were routinely grown in a 37°C incubator, without agitation. Cultures were incubated for 12-75 hours.
Blood plate culture media : Standard 90 mm plate (Petri dishes) containing TSA + 5% sheep blood. Blood plates were purchased from Hylabs (Rehovot, Israel, Cat No. PD- 049).
Flocked Swabs : Swabs with a tip of short nylon brush-like fibers designed for efficient absorption and elution, purchased from Puritan Diagnostics (Maine, USA, Cat No. 25-3306-H).
Saliva swab: Saliva swabs were obtained from patients enrolled in the Clinical Trial. Patients were asked to suck on a flocked swab for approximately 10 seconds. Saliva swabs obtained from Clinical Trial subjects were inoculated onto blood plates and beta-hemolytic colonies were counted using a light table.
Summary of Results
The amounts of GAS captured in saliva swab plates from 28 patients enrolled in phase 2 of the Proof of Concept Clinical trial indicate that unincubated saliva swab samples can be used with Alere™ i technology for detection of GAS, as seen in Table 2A and Table 2B of Figs. 4A/1-4A/2 and 4B, respectively. The data in Table 2A represent an underestimate of whether Alere™ i technology would be sensitive enough to detect GAS from each unincubated saliva swab clinical sample. The GAS found on each saliva swab plate was used as an underestimate for the total amount of GAS in the saliva swab. The average LOD of the Alere™ i device (28 CFUs) was used as the baseline for the projected test result of each saliva swab had they been tested with Alere™ i.
Table 2B presents an underestimated analysis of the 28 saliva swab clinical sample results had they been tested directly using Alere™ i. The calculated projected sensitivity is approximately 76.3% and specificity is approximately 100%.
These data support of the use of Alere™ i and other highly sensitive rapid detection methods with low LOD (including PCR-based methods) for use in identifying the presence of GAS in a saliva sample without incubation. The saliva swab plate data from 28 patients enrolled in the Clinical Trial is presented as a rough estimate for the total amount of GAS present in each saliva sample. It is important to note that the amount of GAS is a major underestimate for the total GAS in each case due to incomplete elution onto the test culture plate compared to more efficient elution into elution buffer. Therefore, the inventors hypothesize that the actual Alere™ i sensitivity for detection of GAS in saliva swab samples would be much higher than the projected Alere™ i sensitivity presented hereinabove.
In an embodiment, the techniques and apparatus described are combined with techniques and apparatus described in one or more of the following patent applications, which are assigned to the assignee of the present application and incorporated herein by reference: • PCT Publication WO 2018/158768 to Fruchter et al.;
• US Provisional Application 62/727,268, filed September 5, 2018; and/or
• an international application filed on even date herein with, entitled, "Testing for particulates."
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

1. A method comprising:
receiving, from a patient, saliva not swabbed from the patient's throat; and performing a rapid strep test (RST) on at least a portion of the saliva using a nucleic acid detection RST technique,
wherein the method does not comprise incubating the saliva before performing the
RST.
2. The method according to claim 1, wherein performing the RST comprises performing the RST on at least a portion of the saliva using a nucleic acid amplification technique selected from the group consisting of: isothermal amplification and real-time polymerase chain reaction (qPCR) assaying.
3. The method according to claim 2, wherein the RST technique is isothermal amplification.
4. The method according to claim 2, wherein the RST technique is qPCR.
5. The method according to claim 1, wherein receiving the saliva from the patient comprises receiving saliva spit by the patient.
6. A method comprising:
receiving gargled fluid from a patient; and
performing a rapid strep test (RST) on at least a portion of the gargled fluid using a nucleic acid detection RST technique,
wherein the method does not comprise incubating the gargled fluid before performing the RST.
7. The method according to claim 6, wherein performing the RST comprises performing the RST on at least a portion of the gargled fluid using a nucleic acid amplification technique selected from the group consisting of: isothermal amplification and real-time polymerase chain reaction (qPCR) assaying.
8. The method according to claim 7, wherein the RST technique is isothermal amplification.
9. The method according to claim 7, wherein the RST technique is qPCR.
PCT/IL2019/050994 2018-09-05 2019-09-05 Strep testing methods WO2020049566A1 (en)

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US62/727,208 2018-09-05

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021044417A1 (en) 2019-09-05 2021-03-11 Hero Scientific Ltd. Self-contained strep testing devices
WO2021181339A1 (en) 2020-03-11 2021-09-16 Hero Scientific Ltd. Testing devices
WO2021181338A1 (en) 2020-03-11 2021-09-16 Hero Scientific Ltd. Testing for viruses and cellular biomarkers
WO2021224925A1 (en) 2020-05-06 2021-11-11 Hero Scientific Ltd. Nasal-spray sampling
WO2022044002A1 (en) 2020-08-28 2022-03-03 Hero Scientific Ltd. Filtration testing devices
WO2022149135A2 (en) 2021-01-06 2022-07-14 Hero Scientific Ltd. Filtration sampling devices
WO2023095146A1 (en) 2021-11-29 2023-06-01 Hero Scientific Ltd. Improved test strip results
WO2023131948A2 (en) 2022-01-06 2023-07-13 Hero Scientific Ltd. Filtration sampling and testing devices
WO2024013747A2 (en) 2022-07-13 2024-01-18 Hero Scientific Ltd. Filtration sampling and testing devices

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100273177A1 (en) * 2006-12-08 2010-10-28 Piasio Roger N Methods and Devices for Testing Saliva
US20130023443A1 (en) * 2010-03-31 2013-01-24 Yamaguchi Technology Licensing Organization,Ltd. Method for detecting pneumonia causative bacteria using nucleic acid chromatography
US20130059290A1 (en) * 2009-09-25 2013-03-07 Alere San Diego, Inc. Detection of nucleic acids in crude matrices
US20150093749A1 (en) * 2012-02-29 2015-04-02 Vela Operations Pte. Ltd. Real-time pcr detection of streptococcus pyogenes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100273177A1 (en) * 2006-12-08 2010-10-28 Piasio Roger N Methods and Devices for Testing Saliva
US20130059290A1 (en) * 2009-09-25 2013-03-07 Alere San Diego, Inc. Detection of nucleic acids in crude matrices
US20130023443A1 (en) * 2010-03-31 2013-01-24 Yamaguchi Technology Licensing Organization,Ltd. Method for detecting pneumonia causative bacteria using nucleic acid chromatography
US20150093749A1 (en) * 2012-02-29 2015-04-02 Vela Operations Pte. Ltd. Real-time pcr detection of streptococcus pyogenes

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021044417A1 (en) 2019-09-05 2021-03-11 Hero Scientific Ltd. Self-contained strep testing devices
WO2021181339A1 (en) 2020-03-11 2021-09-16 Hero Scientific Ltd. Testing devices
WO2021181338A1 (en) 2020-03-11 2021-09-16 Hero Scientific Ltd. Testing for viruses and cellular biomarkers
WO2021224925A1 (en) 2020-05-06 2021-11-11 Hero Scientific Ltd. Nasal-spray sampling
WO2022044002A1 (en) 2020-08-28 2022-03-03 Hero Scientific Ltd. Filtration testing devices
WO2022149135A2 (en) 2021-01-06 2022-07-14 Hero Scientific Ltd. Filtration sampling devices
US11885722B2 (en) 2021-01-06 2024-01-30 Hero Scientific Ltd. Filtration sampling devices
US11921018B2 (en) 2021-01-06 2024-03-05 Hero Scientific Ltd. Filtration sampling devices
WO2023095146A1 (en) 2021-11-29 2023-06-01 Hero Scientific Ltd. Improved test strip results
WO2023131948A2 (en) 2022-01-06 2023-07-13 Hero Scientific Ltd. Filtration sampling and testing devices
WO2024013747A2 (en) 2022-07-13 2024-01-18 Hero Scientific Ltd. Filtration sampling and testing devices

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